TY - CONF T1 - Precision cancer medicine: What has translated into clinical use in Belgium? T2 - Seminars in Cancer Biology Y1 - 2022 A1 - Marie Delnord A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Aline Antoniou A1 - Wannes Van Hoof A1 - Anouk Waeytens A1 - Marc Van den Bulcke JF - Seminars in Cancer Biology PB - Academic Press VL - 84 SN - 1044-579X ER - TY - JOUR T1 - PRECISION: the Belgian molecular profiling program of metastatic cancer for clinical decision and treatment assignment. JF - ESMO Open Y1 - 2022 A1 - J Thouvenin A1 - C Van Marcke A1 - L Decoster A1 - Gordana Raicevic A1 - K Punie A1 - Marc Van den Bulcke A1 - R Salgado A1 - Els Van Valckenborgh A1 - B Maes A1 - S Joris A1 - D Vander Steichel A1 - K Vranken A1 - S Jacobs A1 - F Dedeurwaerdere A1 - G Martens A1 - H Devos A1 - F P Duhoux A1 - M Rasschaert A1 - P Pauwels A1 - K Geboes A1 - J Collignon A1 - S Tejpar A1 - J-L Canon A1 - Michael Peeters A1 - A Rutten A1 - T Van de Mooter A1 - J Vermeij A1 - D Schrijvers A1 - W Demey A1 - W Lybaert A1 - J Van Huysse A1 - J Mebis A1 - A Awada A1 - K B M Claes A1 - Aline Hébrant A1 - J Van der Meulen A1 - B Delafontaine A1 - I Vanden Bempt A1 - J Maetens A1 - Maïté de Hemptinne A1 - S Rottey A1 - P Aftimos A1 - J De Grève KW - Belgium KW - Genomics KW - Humans KW - Medical Oncology KW - Neoplasms KW - Precision Medicine AB -

PRECISION is an initiative from the Belgian Society of Medical Oncology (BSMO) in collaboration with several stakeholders, encompassing four programs that aim to boost genomic and clinical knowledge with the ultimate goal to offer patients with metastatic solid tumors molecularly guided treatments. The PRECISION 1 study has led to the creation of a clinico-genomic database. The Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT) and GeNeo studies will increase the number of patients with advanced cancer that have comprehensive genotyping of their cancer. The PRECISION 2 project consists of investigator-initiated phase II studies aiming to provide access to a targeted drug for patients whose tumors harbor actionable mutations in case the matched drug is not available through reimbursement or clinical trials in Belgium.

VL - 7 CP - 4 M3 - 10.1016/j.esmoop.2022.100524 ER - TY - JOUR T1 - Predictive model for BNT162b2 vaccine response in cancer patients based on blood cytokines and growth factors. JF - Front Immunol Y1 - 2022 A1 - Angelina Konnova A1 - Fien H R De Winter A1 - Gupta, Akshita A1 - An Hotterbeekx A1 - Matilda Berkell A1 - Samir Kumar-Singh ED - Goossens, Herman ED - Surbhi Malhotra-Kumar KW - BNT162 Vaccine KW - COVID-19 KW - Cytokines KW - Female KW - Humans KW - Intercellular Signaling Peptides and Proteins KW - Neoplasms KW - Placenta Growth Factor KW - vaccines AB -

BACKGROUND: Patients with cancer, especially hematological cancer, are at increased risk for breakthrough COVID-19 infection. So far, a predictive biomarker that can assess compromised vaccine-induced anti-SARS-CoV-2 immunity in cancer patients has not been proposed.

METHODS: We employed machine learning approaches to identify a biomarker signature based on blood cytokines, chemokines, and immune- and non-immune-related growth factors linked to vaccine immunogenicity in 199 cancer patients receiving the BNT162b2 vaccine.

RESULTS: C-reactive protein (general marker of inflammation), interleukin (IL)-15 (a pro-inflammatory cytokine), IL-18 (interferon-gamma inducing factor), and placental growth factor (an angiogenic cytokine) correctly classified patients with a diminished vaccine response assessed at day 49 with >80% accuracy. Amongst these, CRP showed the highest predictive value for poor response to vaccine administration. Importantly, this unique signature of vaccine response was present at different studied timepoints both before and after vaccination and was not majorly affected by different anti-cancer treatments.

CONCLUSION: We propose a blood-based signature of cytokines and growth factors that can be employed in identifying cancer patients at persistent high risk of COVID-19 despite vaccination with BNT162b2. Our data also suggest that such a signature may reflect the inherent immunological constitution of some cancer patients who are refractive to immunotherapy.

VL - 13 M3 - 10.3389/fimmu.2022.1062136 ER - TY - JOUR T1 - The Belgian practice and attitudes towards introducing genomics in clinical oncology JF - Belgian journal of medical oncology Y1 - 2021 A1 - Marc Van den Bulcke A1 - Wannes Van Hoof A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Gordana Rajcevic A1 - Kristof Van Assche VL - 15 CP - 4 ER - TY - RPRT T1 - IPAAC Rapport WP4 : Cancer control policy interview survey Y1 - 2021 A1 - Regine Kiasuwa A1 - Laure Bakker A1 - Marc Van den Bulcke KW - cancer KW - policymaking KW - sustainability AB -

From July 2018 to January 2020, the Innovative Partnership for Action Against Cancer (iPAAC) Work Package 4 (WP4) performed a survey among European Union (EU) Member States to capture their experience and challenges regarding the implementation of cancer control policies. In total, 28 countries were visited, and the meeting minutes were inductively coded using NVivo qualitative analysis software to provide the core data for this report (https://www.ipaac.eu/res/file/outputs/wp4/ipaac_wp4_ccpis_methodological...).

Two important and consistent rationale for action were found: quality and equity. Through all cancer control domains, the objectives are the same: ensure quality and tackle inequities.

When it comes to primary prevention, all countries reported having pursued innovative approaches to better inform and communicate with key stakeholders, especially related to children, adolescents and young adults (AYAs) and lower socio-economic groups. A recurrent issue concerns the sustainability of primary prevention actions. A vicious circle exists due to the difficulty in measuring short-term impacts, which in turn, does not provide support for the provision of structural budgets. Register-based collection of structured and validated data of lifestyles and interventions from electronic data sources in health care would be a key to evaluation and to generate evidence-based recommendations.

A second important challenge relates to the interference of the corporate giants of the tobacco, alcohol and food industries. Regulatory actions as well as inter-ministerial and inter-sectorial platforms have proven their efficacy to mitigate the influence of these corporate interests and promote the pursuit and maintenance of healthy lifestyles.

Regarding cancer screening, the extent of implementation of screening programs varies widely among EU Member States. The most often reported challenges concern test selection, non-appropriate governance and/or legal frameworks and the effectiveness of population-based screening programs. Some countries, as well as the scientific community, are investigating the possibility of shifting to high-risk stratified screening programme. Some groups have been found to have systematically lower compliance to organized screening programs. Special attention should be given to the means of reaching, informing and inviting these specific populations. The involvement of community health professionals (pharmacists or nurses) and the training of community lay workers have been reported by several countries to better inform the population and raise the participation of target groups to screening.

Cancer diagnostics and treatment are of high importance for both quality and equity. Most countries struggle with controlling the rise of the costs of innovation that put the sustainability of their systems at risk. Also, the rapid pace of some innovations can require regular adjustments in reimbursement schemes and decision-making processes. EU cooperation on these two matters is highly sought and needed.

Cancer care provision and organization is at the heart of action in most EU countries. It regulates the ‚what and how‘ for cancer patients and their family. Waiting times, lack of cancer care professionals, cultural habits and quality control are recurrent challenges reported by EU countries. In addition, the lack of knowledge and the persistent need to identify best practices, especially for long-term care have been raised. Comprehensive cancer care networks, patient pathways and coordinated activities have been reported as the current ways to improve and ensure quality and equity in the provision of cancer care. More efforts are needed to investigate (evidence-based) improvements that focus on a more patient-centered provision of care, especially for rehabilitation and palliative care. Rare cancers are specific priorities for these networks, especially in relation to European Reference Networks (ERNs).

Cancer information systems intersect all dimensions of cancer control and are mainly organized through cancer registries. However, their mandate and subsequent ability to support evidence-based cancer control policy varies widely. The possibility to link with other health, administrative or socio-economical information sources is key but requires legal, ethical and technical adjustments. Enhancing digitalization, data integration and interoperability ‘by design’ is crucial and requires global strategies and resources. In a context of increasing prevalence the lack of data on the whole disease trajectory, including quality of life and survivorship, is considered critical. Also, patient and carers perspectives need to be integrated to ensure meeting their needs and support development of patient-centered interventions.

Overall, EU countries are engaged in many cancer control efforts, with differing foci according to specific national needs, political agendas and resources. However, maximum capacity seem to have been reached in many domains and the support from the European Commission (EC) would help to overcome persistent challenges. Three types of support are required. First support for research, including epidemiology and health services research leading to the identification of best practices and the development of guidance. Second, support for knowledge exchange among EU countries on cancer control policy implementation. Third, legal frameworks, i.e. regulations, have the power to ensure coherent activities and provide binding force to expected good quality practice. To ensure improved effectiveness and cost-effectiveness, these three key types of support need to be organized and developed in parallel, integrated and well documented.

PB - Sciensano UR - https://www.ipaac.eu/res/file/outputs/wp4/ccpis-report.pdf ER - TY - JOUR T1 - Poor antibody response to BioNTech/Pfizer COVID-19 vaccination in SARS-CoV-2 naïve residents of nursing homes. JF - Clin Infect Dis Y1 - 2021 A1 - Pieter Pannus A1 - Kristof Y Neven A1 - Stéphane De Craeye A1 - Heyndrickx, Leo A1 - Sara Vande Kerckhove A1 - Daphnée Georges A1 - Johan Michiels A1 - Antoine Francotte A1 - Marc Van den Bulcke A1 - Maan Zrein A1 - Steven Van Gucht A1 - Marie-Noëlle Schmickler A1 - Mathieu Verbrugghe A1 - André Matagne A1 - Isabelle Thomas A1 - Katelijne Dierick A1 - Joshua A Weiner A1 - Margaret E Ackerman A1 - Stanislas Goriely A1 - Maria Goossens A1 - Ariën, Kevin K A1 - I Desombere A1 - Arnaud Marchant AB -

BACKGROUND: Residents of nursing homes (NH) are at high risk of COVID-19 related morbidity and death and may respond poorly to vaccination because of old age and frequent comorbidities.

METHODS: Seventy-eight residents and 106 staff members, naïve or previously infected with SARS-CoV-2, were recruited in NH in Belgium before immunization with two doses of 30µg BNT162b2 mRNA vaccine at day 0 and day 21. Binding antibodies (Ab) to SARS-CoV-2 receptor binding domain (RBD), spike domains S1 and S2, RBD Ab avidity, and neutralizing Ab against SARS-CoV-2 wild type and B.1.351 were assessed at days 0, 21, 28, and 49.

RESULTS: SARS-CoV-2 naïve residents had lower Ab responses to BNT162b2 mRNA vaccination than naïve staff. These poor responses involved lower levels of IgG to all spike domains, lower avidity of RBD IgG, and lower levels of Ab neutralizing the vaccine strain. No naïve resident had detectable neutralizing Ab to the B.1.351 variant. In contrast, SARS-CoV-2 infected residents had high responses to mRNA vaccination, with Ab levels comparable to infected staff. Cluster analysis revealed that poor vaccine responders not only included naïve residents but also naïve staff, emphasizing the heterogeneity of responses to mRNA vaccination in the general population.

CONCLUSIONS: The poor Ab responses to mRNA vaccination observed in infection naïve residents and in some naïve staff members of NH suggest suboptimal protection against breakthrough infection, especially with variants of concern. These data support the administration of a third dose of mRNA vaccine to further improve protection of NH residents against COVID-19.

M3 - 10.1093/cid/ciab998 ER - TY - JOUR T1 - Precision cancer medicine: What has translated into clinical use in Belgium? JF - Semin Cancer Biol Y1 - 2021 A1 - Marie Delnord A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Aline Antoniou A1 - Wannes Van Hoof A1 - Anouk Waeytens A1 - Marc Van den Bulcke KW - cancer KW - EVALUATION KW - implementation KW - Precision Medicine AB -

RATIONALE: In 2016, Belgium launched the Next Generation Sequencing (NGS) Roadbook, consisting in 10 Actions, across the health care system, to facilitate the uptake of NGS in routine clinical practice. We compiled feedback on deployment of the NGS Roadbook from governmental stakeholders and beneficiaries: health policy makers, insurance providers, pathologists, geneticists, and oncologists.

MAIN FINDINGS: The Roadbook ensured the establishment of a Commission on Personalized Medicine and NGS testing guidelines. A national benchmarking trial ensued, and 10 networks of hospitals and laboratories adopted a reimbursement convention with the Belgian Health Insurance Agency. The Healthdata.be platform centralizes the collection of NGS metrics, and citizens were consulted on their views about NGS and genomics.

CONCLUSION: The Roadbook facilitated the implementation of NGS in routine (hemato-)oncology care in Belgium. Some challenges remain linked to data sharing and access by a wider range of stakeholders. Next steps include continuous monitoring of health outcomes and the budgetary impact.

M3 - 10.1016/j.semcancer.2021.06.010 ER - TY - JOUR T1 - Reduced humoral immune response after BNT162b2 coronavirus disease 2019 messenger RNA vaccination in cancer patients under antineoplastic treatment. JF - ESMO Open Y1 - 2021 A1 - M Peeters ED - L Verbruggen ED - L Teuwen ED - G Vanhoutte ED - S Raats ED - Isolde Van der Massen ED - Sigrid C.J. De Keersmaecker ED - Y Debie ED - S Anguille KW - Antineoplastic Agents KW - BNT162 Vaccine KW - COVID-19 KW - COVID-19 Vaccines KW - Humans KW - Immunity, Humoral KW - Neoplasms KW - Prospective Studies KW - RNA, Messenger KW - SARS-CoV-2 KW - Vaccination AB -

BACKGROUND: Cancer patients are at a higher risk of developing severe coronavirus disease 2019 (COVID-19). However, the safety and efficacy of COVID-19 vaccination in cancer patients undergoing treatment remain unclear.

PATIENTS AND METHODS: In this interventional prospective multicohort study, priming and booster doses of the BNT162b2 COVID-19 vaccine were administered 21 days apart to solid tumor patients receiving chemotherapy, immunotherapy, targeted or hormonal therapy, and patients with a hematologic malignancy receiving rituximab or after allogeneic hematopoietic stem cell transplantation. Vaccine safety and efficacy (until 3 months post-booster) were assessed. Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) receptor-binding domain (RBD) antibody levels were followed over time (until 28 days after the booster) and in vitro SARS-CoV-2 50% neutralization titers (NT50) toward the wild-type Wuhan strain were analyzed 28 days after the booster.

RESULTS: Local and systemic adverse events (AEs) were mostly mild to moderate (only 1%-3% of patients experienced severe AEs). Local, but not systemic, AEs occurred more frequently after the booster dose. Twenty-eight days after the booster vaccination of 197 cancer patients, RBD-binding antibody titers and NT50 were lower in the chemotherapy group {234.05 IU/ml [95% confidence interval (CI) 122.10-448.66] and 24.54 (95% CI 14.50-41.52), respectively} compared with healthy individuals [1844.93 IU/ml (95% CI 1383.57-2460.14) and 122.63 (95% CI 76.85-195.67), respectively], irrespective of timing of vaccination during chemotherapy cycles. Extremely low antibody responses were seen in hematology patients receiving rituximab; only two patients had RBD-binding antibody titers necessary for 50% protection against symptomatic SARS-CoV-2 infection (<200 IU/ml) and only one had NT50 above the limit of detection. During the study period, five cancer patients tested positive for SARS-CoV-2 infection, including a case of severe COVID-19 in a patient receiving rituximab, resulting in a 2-week hospital admission.

CONCLUSION: The BNT162b2 vaccine is well-tolerated in cancer patients under active treatment. However, the antibody response of immunized cancer patients was delayed and diminished, mainly in patients receiving chemotherapy or rituximab, resulting in breakthrough infections.

VL - 6 CP - 5 M3 - 10.1016/j.esmoop.2021.100274 ER - TY - JOUR T1 - BELGIAN CANCER BAROMETER 2020 Methodology for the working groups Y1 - 2020 A1 - Regine Kiasuwa A1 - M. Van Den Broecke A1 - Marc Van den Bulcke KW - cancer KW - cancer screening AB -

Introduction

The Belgian Cancer Barometer 2020 (BCB2020) is a project commissioned and funded by the Belgian Foundation Against Cancer. The Belgian Cancer Centre of Sciensano is the project coordinator and works in close collaboration with the Belgian Cancer Registry and the College of Oncology. Although not a member of the Steering Committee, the Belgian Healthcare Knowledge Centre (KCE) is also involved in supporting the working groups with existing evidence collected by the KCE on economic evaluation.

The BCB 2020 aims to provide a political and epidemiological state-of-play of cancer control in Belgium. The remaining challenges for patients, professionals and policy-makers will be identified and recommendations on how to overcome these challenges will be made.

The BCB2020 will encompass five domains, also purpose of the five BCB2020 working groups:

Four transversal topics will structure each domain:

The inclusion of patient perception is key in identifying remaining challenges in cancer control in Belgium within the BCB2020. In providing an epidemiological and political state-of-play, an evidence-based approach (scientific justification) will be used and international comparisons will be made (European level).
In addition to patients, other relevant stakeholders will be surveyed/ questioned on their perspectives concerning the previously stated domains and on their views on (remaining) challenges and possible recommendations.

During three preliminary meetings and five preparatory meetings with members of the Steering Committee, the framework and objectives of the project have been discussed and agreed on. Following a close look at the scientifc literature and Belgian regulatory frameworks, the Steering Committee decided to focus on three aspects: an epidemiological and political state of play for each domain; the capture of the perspective of patients, relatives and the general public and, the formulation of recommendations to improve cancer control in Belgium (including the identification of needs for future research).

Within a bit less than one year, experts (also including patients and informal caregivers?)/ experienced professionals in relevant fields of study/work will be invited to participate in working groups organized by domains and by topics within these domains.
As for the final result of the project, a comprehensive report will be written mainly targetting policy-makers but also the general public as the reading audience.

ER - TY - JOUR T1 - NGS for (Hemato-) Oncology in Belgium: Evaluation of Laboratory Performance and Feasibility of a National External Quality Assessment Program JF - Cancers Y1 - 2020 A1 - Thomas Delcourt A1 - Kevin Vanneste A1 - Mohamed Rida Soumali A1 - Wim Coucke A1 - V Ghislain A1 - Aline Hébrant A1 - Els Van Valckenborgh A1 - Sigrid C.J. De Keersmaecker A1 - Nancy Roosens A1 - P Van de Walle A1 - Marc Van den Bulcke A1 - Aline Antoniou KW - next-generation sequencing; hemato-oncology; oncology; external quality assessment; cancer AB -

Next-generation sequencing (NGS) is being integrated into routine clinical practice in the field of (hemato-) oncology to search for variants with diagnostic, prognostic, or therapeutic value at potentially low allelic frequencies. The complex sequencing workflows used require careful validation and continuous quality control. Participation in external quality assessments (EQA) helps laboratories evaluate their performance and guarantee the validity of tests results with the ultimate goal of ensuring high-quality patient care. Here, we describe three benchmarking trials performed during the period 2017–2018 aiming firstly at establishing the state-of-the-art and secondly setting up a NGS-specific EQA program at the national level in the field of clinical (hemato-) oncology in Belgium. DNAsamples derived from cell line mixes and artificially mutated cell lines, designed to carry variants of clinical relevance occurring in solid tumors, hematological malignancies, and BRCA1/BRCA2 genes, were sent to Belgian human genetics, anatomic pathology, and clinical biology laboratories, to be processed following routine practices, together with surveys covering technical aspects of the NGS workflows. Despite the wide variety of platforms and workflows currently applied in routine clinical practice, performance was satisfactory, since participating laboratories identified the targeted variants with success rates ranging between 93.06% and 97.63% depending on the benchmark, and few false negative or repeatability issues were identified. However, variant reporting and interpretation varied, underlining the need for further standardization. Our approach showcases the feasibility of developing and implementing EQA for routine clinical practice in the field of (hemato-) oncology, while highlighting the challenges faced.

VL - 12 CP - 11 M3 - 10.3390/cancers12113180 ER - TY - JOUR T1 - Towards a European health research and innovation cloud (HRIC) JF - Genome Medicine Y1 - 2020 A1 - F.M. Aarestrup A1 - A. Albeyatti A1 - W. J. Armitage A1 - C. Auffray A1 - L. Augello A1 - R. Balling A1 - N. Benhabiles A1 - G. Bertolini A1 - J. G. Bjaalie A1 - M. Black A1 - N. Blomberg A1 - Petronille Bogaert A1 - M. Bubak A1 - B. Claerhout A1 - L. Clarke A1 - B. De Meulder A1 - G. D’Errico A1 - A. Di Meglio A1 - N. Forgo A1 - C. Gans-Combe A1 - A. E. Gray A1 - I. Gut A1 - A. Gyllenberg A1 - G. Hemmrich-Stanisak A1 - L. Hjorth A1 - Y. Ioannidis A1 - S. Jarmalaite A1 - A. Kel A1 - F. Kherif A1 - J. O. Korbel A1 - C. Larue A1 - M. Laszlo A1 - A. Maas A1 - L. Magalhaes A1 - I. Manneh-Vangramberen A1 - E. Morley-Fletcher A1 - C. Ohmann A1 - P. Oksvold A1 - N. P. Oxtoby A1 - I. Perseil A1 - V. Pezoulas A1 - O. Riess A1 - H. Riper A1 - J. Roca A1 - P. Rosenstiel A1 - P. Sabatier A1 - F. Sanz A1 - M. Tayeb A1 - G. Thomassen A1 - Johan Van Bussel A1 - Marc Van den Bulcke A1 - Herman Van Oyen AB -

The European Union (EU) initiative on the Digital Transformation of Health and Care (Digicare) aims to provide the conditions necessary for building a secure, flexible, and decentralized digital health infrastructure. Creating a European Health Research and Innovation Cloud (HRIC) within this environment should enable data sharing and analysis for health research across the EU, in compliance with data protection legislation while preserving the full trust of the participants. Such a HRIC should learn from and build on existing data infrastructures, integrate best practices, and focus on the concrete needs of the community in terms of technologies, governance, management, regulation, and ethics requirements. Here, we describe the vision and expected benefits of digital data sharing in health research activities and present a roadmap that fosters the opportunities while answering the challenges of implementing a HRIC. For this, we put forward five specific recommendations and action points to ensure that a European HRIC: i) is built on established standards and guidelines, providing cloud technologies through an open and decentralized infrastructure; ii) is developed and certified to the highest standards of interoperability and data security that can be trusted by all stakeholders; iii) is supported by a robust ethical and legal framework that is compliant with the EU General Data Protection Regulation (GDPR); iv) establishes a proper environment for the training of new generations of data and medical scientists; and v) stimulates research and innovation in transnational collaborations through public and private initiatives and partnerships funded by the EU through Horizon 2020 and Horizon Europe.

VL - 12 CP - 1 M3 - 10.1186/s13073-020-0713-z ER - TY - JOUR T1 - Algorithms for molecular testing in solid tumours JF - Belgian Journal of Medical Oncology (BJMO Y1 - 2019 A1 - Aline Hébrant A1 - M Lammens A1 - C Van den Broeck A1 - N. D’Haene A1 - J Van den Oord A1 - A. Vanderstichele A1 - A Dendooven A1 - P Neven A1 - K Punie A1 - G Floris A1 - J Van der Meulen A1 - H A Poirel A1 - C Dooms A1 - S Rottey A1 - T Boterberg A1 - L Brochez A1 - MC Burlacu A1 - G Costante A1 - D Creytens A1 - De Paepe, P A1 - R De Pauwn A1 - B Decallonne A1 - F Dedeurwaerdere A1 - H Denys A1 - L Ferdinande A1 - R Forsyth A1 - M Garmyn A1 - T Gevaert A1 - J De Grève A1 - E Govaerts A1 - E Hauben A1 - J Kerger A1 - O Kholmanskikh Van Criekingen A1 - V Kruse A1 - Y Lalami A1 - L Lapeire A1 - P Lefesvre A1 - JP Machiels A1 - B Maes A1 - G Martens A1 - M Remmelink A1 - I Salmon A1 - R Sciot A1 - S Tejpar A1 - K Van de Vijver A1 - L Van de Voorde A1 - I Van den Berghe A1 - A Van den Bruel A1 - K Vandecasteele A1 - L Vanwalleghem A1 - K Vermaelen A1 - R Salgado A1 - E Wauters A1 - B Weynand A1 - Els Van Valckenborgh A1 - G Raicevic A1 - Marc Van den Bulcke A1 - P Pauwels AB -

In order to advise the Federal Government on the reimbursement of molecular tests related to Personalised Medicine in Oncology, the Commission of Personalised Medicine (ComPerMed), represented by Belgian experts, has developed a methodology to classify molecular testing in oncology. The different molecular tests per cancer type are represented in algorithms and are annotated with a test level reflecting their relevance based on current guidelines, drug approvals and clinical data. The molecular tests are documented with recent literature, guidelines and a brief technical description. This methodology was applied on different solid tumours for which molecular testing is a clear clinical need.

VL - 13 CP - 7 ER - TY - JOUR T1 - Diagnostic testing in myeloid malignancies by next-generation sequencing: recommendations from the commission personalised medicine JF - Belgian Journal of Hematology Y1 - 2019 A1 - Els Van Valckenborgh A1 - E Boone A1 - A Camboni A1 - JP Defour A1 - B Denys A1 - H Devos A1 - L Dewispelaere A1 - Guy Froyen A1 - Aline Hébrant A1 - P Heimann A1 - P Hermans A1 - E Heylen A1 - K Jacobs A1 - F Lambert A1 - Marie Le Mercier A1 - Els Lierman A1 - H Louagie A1 - B Maes A1 - MB Maes A1 - G Martens A1 - L Michaux A1 - Friedel Nollet A1 - H A Poirel A1 - G Raicevic A1 - P Saussoy A1 - T Tousseyn A1 - Marc Van den Bulcke A1 - P Vandenberghe A1 - Karl Vandepoele A1 - P Vannuffel A1 - T Venken A1 - K Vermeulen AB -

Molecular diagnostics have an increasing impact on diagnosis, risk stratification and targeted treatment in haemato-oncology. In the framework of a pilot study for the implementation of next-generation sequencing in the Belgian healthcare system, the Commission of Personalised Medicine was founded to give professional and evidence-based advice on the molecular analysis in haemato-oncology. This paper describes its recommendations for NGS analysis in myeloid malignancies. In addition, the minimally required set of genes that must be analysed is defined and algorithms for molecular workflow in myeloid malignancies are proposed.

VL - 10 CP - 6 ER - TY - JOUR T1 - Molecular test algorithms for breast tumours JF - Belgian Journal of Medical Oncology Y1 - 2019 A1 - Aline Hébrant A1 - K Punie A1 - FP Duhoux A1 - C Colpaert A1 - G Floris A1 - K Lambein A1 - P Neven A1 - M Berlière A1 - R Salgado A1 - M Chintinne A1 - K Dahan A1 - S Dedeurwaerdere A1 - J De Grève A1 - A de Leener A1 - H Denys A1 - R de Putter A1 - L Desmyter A1 - M Baldewijns A1 - D Feret A1 - C Fontaine A1 - C Galant A1 - P Hilbert A1 - J Janssens A1 - D Larsimont A1 - P Lefesvre A1 - T Sticca A1 - MD Tkint de Roodenbeke A1 - I Vanden Bempt A1 - C Van den Broeck A1 - I Vandernoot A1 - C Sotiriou A1 - J Van Dorpe A1 - H Antoine-Poirel A1 - Els Van Valckenborgh A1 - Gordana Raicevic A1 - Marc Van den Bulcke A1 - P Aftimos AB -

In order to advise the Federal Government on all matters related to personalised medicine in oncology, including the reimbursement of molecular tests, the Commission of Personalized Medicine (ComPerMed) has applied, for the breast tumours, the same methodology as previously applied for the digestive tumours. Meaning, the different molecular tests, represented in the shape of algorithms, are annotated with test levels — which aim to reflect their relevance based on current available data and to define the reimbursement — and are documented with recent literature, guidelines and a brief technical description.

VL - 13 CP - 2 ER - TY - JOUR T1 - The genetic structure of the Belgian population JF - Human Genomics Y1 - 2018 A1 - Jimmy Van den Eynden A1 - Tine Descamps A1 - Els Delporte A1 - Nancy Roosens A1 - Sigrid C.J. De Keersmaecker A1 - Vanessa De Wit A1 - Joris Robert Vermeesch A1 - Goetghebeur, Els A1 - Jean Tafforeau A1 - Stefaan Demarest A1 - Marc Van den Bulcke A1 - Herman Van Oyen KW - genetic variability KW - population genomics KW - public health genomics VL - 12 CP - 1 M3 - 10.1186/s40246-018-0136-8 ER - TY - JOUR T1 - Opportunities and challenges in oncology and molecular testing: the Belgian strategy JF - Belg J Med Oncol Y1 - 2018 A1 - Aline Hébrant A1 - Els Van Valckenborgh A1 - Roberto Salgado A1 - Guy Froyen A1 - Frank Hulstaert A1 - Dominique Roberfroid A1 - Sabine Tejpar A1 - Anne Jouret-Mourin A1 - Marc Van den Bulcke A1 - Anouk Waeytens AB - Molecular diagnostics in cancer aiming at improving diagnosis, prognosis and treatment are constantly exposed to new opportunities and challenges. The Belgian Commission of Personalised Medicine (ComPer-Med) has been created to advise the Federal Government on all matters related to personalised medicine in oncology, including the reimbursement of molecular tests. Here, we propose the Belgian strategy for molecular testing within a scientific based framework and its implementation in the Belgian healthcare system. For each tested biomarker a clinical test level is attached, which is key to establish the relevance of the test and to define the reimbursement. VL - 12 CP - 2 ER - TY - JOUR T1 - Perspectives on the integration of Immuno-Oncology Biomarkers and drugs in a Health Care setting. JF - Semin Cancer Biol Y1 - 2018 A1 - K Vermaelen A1 - A Waeytens A1 - O Kholmanskikh A1 - Marc Van den Bulcke A1 - Els Van Valckenborgh KW - Antineoplastic Agents KW - Biomarkers, Tumor KW - Delivery of Health Care KW - Humans KW - Immunotherapy KW - Medical Oncology KW - Neoplasms AB -

Immunotherapies, specifically checkpoint inhibitors, are becoming an important component in cancer care with the most application now in melanoma and lung cancer patients. Some drawbacks that converge with this new evolution are the rather low response rates to these drugs and their high cost with a significant economic impact on the health care system. These major challenges can likely be circumvented by implementing a "personalized immuno-oncology" approach to accomplish a selection of optimal responders based on biomarkers. In this paper we first discuss the legal framework for the development of valuable in vitro diagnostics. Based on a case study in lung cancer, the clinical validity and utility requirements of predictive immuno-oncology biomarkers is highlighted and an overview is given on the evolution towards multiplex or omics-based assays together with its challenges and pitfalls. Finally, some initiatives between the public and private sector are pinpointed to sustain the future access to innovative medicines in cancer therapy at a reasonable cost.

VL - 52 CP - Pt 2 M3 - 10.1016/j.semcancer.2017.11.011 ER - TY - JOUR T1 - Roadbook for the implementation of next-generation sequencing in clinical practice in oncology and hemato-oncology in Belgium. JF - Arch Public Health Y1 - 2018 A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Aline Antoniou A1 - Wannes Van Hoof A1 - Johan Van Bussel A1 - Patrick Pauwels A1 - Roberto Salgado A1 - Waltruda van Doren A1 - Anouk Waeytens A1 - Marc Van den Bulcke AB -

In the field of oncology research, next-generation sequencing has contributed significantly to the discovery of DNA mutations associated with diagnosis and prognosis. It also aids in the development of targeted therapies to specific mutations and the rise of personalized medicine. As part of molecular diagnostics in cancer patients, analysis by next-generation sequencing is becoming part of routine clinical practice. The introduction of this complex technology in a healthcare system comes with multiple challenges and requires a clear action plan. Such an action plan, as outlined in this paper, was developed in Belgium and includes steps in ensuring the quality and indications of NGS testing, installing data registration and tackling ethical issues. A final step is to perform a pilot study to control the access, quality, harmonization and expertise in DNA testing. This action plan can serve as a guide for similar initiatives by other countries to facilitate NGS implementation in clinical practice.

VL - 76 M3 - 10.1186/s13690-018-0295-z ER - TY - Generic T1 - BelPHG-21: a pilot study on genetic variability in the Belgian population Y1 - 2017 A1 - Tine Descamps A1 - Els Delporte A1 - J Vermeesch A1 - Els Goetghebeur A1 - Clement, Lieven A1 - Jean Tafforeau A1 - Stefaan Demarest A1 - Herman Van Oyen A1 - Marc Van den Bulcke A1 - Jimmy Van den Eynden KW - public health genomics JF - European Public Health Conference CY - Stockholm ER - TY - JOUR T1 - CanCon European Guide on Quality Improvement in Comprehensive Cancer Control - Chapter 1: Introduction JF - CanCon Y1 - 2017 A1 - Albreht, Tit A1 - Marc Van den Bulcke A1 - Regine Kiasuwa KW - cancer KW - cancer control SN - ISBN: 978-961-7002-28-7 ER - TY - JOUR T1 - CanCon European Guide on Quality Improvement in Comprehensive Cancer Control JF - CanCon Y1 - 2017 A1 - Albreht, Tit A1 - Marc Van den Bulcke A1 - Regine Kiasuwa KW - cancer KW - cancer control AB -

Cancon Guide is the main delivery of the joint action. The quality improvement of cancer care is at the heart of Guide. Cancon is officially titled European Guide on Quality Improvement in Comprehensive Cancer Control.

The Guide aims to help to reduce not only the cancer burden throughout the EU but also the inequalities in cancer control and care that exist between Member states. The Guide is meant for governments, parliamentarians, health care providers and funders, and cancer care professionals at every level. 

SN - ISBN: 978-961-7002-28-7 ER - TY - JOUR T1 - CanCon European Guide on Quality Improvement in Comprehensive Cancer Control - Chapter 1: Introduction JF - CanCon Y1 - 2017 A1 - T. Albreht A1 - Regine Kiasuwa A1 - Marc Van den Bulcke KW - cancer control KW - cancon ER - TY - RPRT T1 - European guide on quality improvement in comprehensive cancer control Y1 - 2017 A1 - Albreht, Tit A1 - Regine Kiasuwa A1 - Marc Van den Bulcke ER - TY - JOUR T1 - The Belgian NGS guidelines for (haemato)-oncology: 2016- version 01 JF - BSMO J Y1 - 2016 A1 - Aline Hébrant A1 - Froyen,G. A1 - Maes,B. A1 - Salgado,R. A1 - Le Mercier,M. A1 - D'Haene,N. A1 - Sigrid C.J. De Keersmaecker A1 - Claes,K. A1 - Van der Meulen,J. A1 - Aftimos,P. A1 - Van Houdt,J. A1 - Cuppens,K. A1 - Kevin Vanneste A1 - Dequeker,E. A1 - Van Dooren,S. A1 - Van Huysse,J. A1 - Nollet,F. A1 - van Laere,S. A1 - Denys,B. A1 - V Ghislain A1 - C . Van Campenhout A1 - Marc Van den Bulcke KW - / KW - Belgian KW - Guidelines KW - NGS KW - Version AB - / VL - / U1 - 5785 ER - TY - Generic T1 - Symposium NGS 2016 - Introductie (NL) Y1 - 2016 A1 - Marc Van den Bulcke KW - Next-generation sequencing (NGS) KW - NGS KW - oncology KW - personalized medicine KW - treatment AB -

Introductie Symposium NGS 2016 

JF - Symposium NGS 2016 PB - Sciensano CY - Brussels, Belgium ER - TY - Generic T1 - Symposium NGS 2016 - ‘Next generation sequencing’ technology in routine analysis in Belgian healthcare system (EN) Y1 - 2016 A1 - Marc Van den Bulcke KW - Next-generation sequencing (NGS) KW - NGS KW - oncology KW - personalized medicine KW - treatment AB -

'Next generation sequencing’ technology in routine analysis in Belgian healthcare system.

JF - Symposium NGS 2016 PB - Sciensano CY - Brussels, Belgium ER - TY - JOUR T1 - Greater patient access to immuno-oncology therapies-what can policymakers do? JF - Ecancermedicalscience Y1 - 2015 A1 - de Lorenzo, Francesco A1 - Wait, Suzanne A1 - Karaca, Burçak A1 - Britten, Cedrik M A1 - Marc Van den Bulcke VL - 9 U1 - http://www.ncbi.nlm.nih.gov/pubmed/25729428?dopt=Abstract M3 - 10.3332/ecancer.2015.ed48 ER - TY - RPRT T1 - European Guide for Quality National Cancer Control Programmes Y1 - 2014 A1 - Albreht, Tit A1 - Borras, Josep M A1 - Fiona Conroy A1 - Miriam Dalmas A1 - Antonio Federici A1 - Lydia Gorgojo A1 - Meggan Harris A1 - Marjetka Jelenc A1 - Regine Kiasuwa A1 - Martin Martin-Moreno A1 - Travado, Luzia A1 - Marc Van den Bulcke ER - TY - JOUR T1 - Inter-laboratory Testing of GMO Detection by Combinatory SYBR®Green PCR Screening (CoSYPS) JF - Food analytical methods Y1 - 2014 A1 - E. Barbau-Piednoir A1 - Stragier,P. A1 - Nancy Roosens A1 - Mazzara,M. A1 - Savini,C. A1 - Van den Eede,G. A1 - Marc Van den Bulcke KW - combinatory KW - CoSYPS KW - detection KW - GMO KW - GMO detection KW - ON KW - PCR KW - SCREENING AB - available on line VL - 7 U1 - 4617 M3 - 10.1007/s12161-014-9837-3 ER - TY - JOUR T1 - Policy statement on multidisciplinary cancer care. JF - Eur J Cancer Y1 - 2014 A1 - Borras, Josep M A1 - Albreht, Tit A1 - Audisio, Riccardo A1 - Briers, Erik A1 - Casali, Paolo A1 - Esperou, Hélène A1 - Grube, Birgitte A1 - Hamoir, Marc A1 - Henning, Geoffrey A1 - Kelly, Joan A1 - Knox, Susan A1 - Nabal, Maria A1 - Pierotti, Marco A1 - Lombardo, Claudio A1 - van Harten, Wim A1 - Poston, Graeme A1 - Prades, Joan A1 - Sant, Milena A1 - Travado, Luzia A1 - Valentini, Vincenzo A1 - van de Velde, Cornelis A1 - van den Bogaert, Saskia A1 - Marc Van den Bulcke A1 - van Hoof, Elke A1 - van den Neucker, Ingrid A1 - Wilson, Robin KW - Consensus KW - Europe KW - Health Care Sector KW - HEALTH POLICY KW - Humans KW - Medical Oncology KW - Neoplasms KW - Patient-Centered Care AB -

BACKGROUND: Cancer care is undergoing an important paradigm shift from a disease-focused management to a patient-centred approach, in which increasingly more attention is paid to psychosocial aspects, quality of life, patients' rights and empowerment and survivorship. In this context, multidisciplinary teams emerge as a practical necessity for optimal coordination among health professionals and clear communication with patients. The European Partnership for Action Against Cancer (EPAAC), an initiative launched by the European Commission in 2009, addressed the multidisciplinary care from a policy perspective in order to define the core elements that all tumour-based multidisciplinary teams (MDTs) should include. To that effect, a working group conference was held in January 2013 within the EPAAC Work Package 7 (on Healthcare) framework.

METHODS: The consensus group consisted of high-level representatives from the following European scientific societies, patient associations and stakeholders: European CanCer Organisation (ECCO), European SocieTy for Radiology & Oncology (ESTRO), European Society for Medical Oncology (ESMO), European Society of Surgical Oncology (ESSO), International Society of Geriatric Oncology (SIOG), European Association for Palliative Care (EAPC), European Oncology Nursing Society (EONS), International Psycho-Oncology Society (IPOS),European Cancer Patient Coalition (ECPC), EuropaColon, Europa Donna - The European Breast Cancer Coalition, Association of European Cancer Leagues (ECL), Organisation of European Cancer Institutes (OECI), EUSOMA - European Society of Breast Cancer Specialists, European Hospital and Healthcare Federation (HOPE) and EPAAC Work Packages 5 (Health promotion and prevention), 7, 8 (Research), 9 (Information systems) and 10 (Cancer plans). A background document with a list of 26 core issues drawn from a systematic review of the literature was used to guide the discussion. Five areas related to MDTs were covered: care objectives, organisation, clinical assessment, patients' rights and empowerment and policy support. Preliminary drafts of the document were widely circulated for consultation and amendments by the working group before final approval.

RESULTS: The working group unanimously formulated a Policy Statement on Multidisciplinary Cancer Care to define the core elements that should be implemented by all tumour-based MDTs. This document identifies MDTs as the core component in cancer care organisation and sets down the key elements to guide changes across all European health systems.

CONCLUSION: MDTs are an essential instrument of effective cancer care policy, and their continued development crucial to providing patients the care they need and deserve. While implementation must remain in local hands, European health systems can still benefit from having a basis for an effective multidisciplinary model of cooperation. This policy statement is intended to serve as a reference for policymakers and healthcare providers who wish to improve the services currently provided to the cancer patients whose lives and well-being depend on their action.

VL - 50 CP - 3 U1 - http://www.ncbi.nlm.nih.gov/pubmed/24321260?dopt=Abstract M3 - 10.1016/j.ejca.2013.11.012 ER - TY - JOUR T1 - The GMOseek matrix: a decision support tool for optimizing the detection of genetically modified plants JF - BMC Bioinformatics Y1 - 2013 A1 - A. Block A1 - Frédéric Debode A1 - L. Grohmann A1 - Hulin,Julie A1 - Isabel Taverniers A1 - L. Kluga A1 - E. Barbau-Piednoir A1 - Sylvia Broeders A1 - Ingrid Huber A1 - Marc Van den Bulcke A1 - Heinze,P. A1 - Berben,G. A1 - U. Busch A1 - Nancy Roosens A1 - Eric Janssen A1 - Jana Zel A1 - Kristina Gruden A1 - Morisset,D. KW - ALL KW - an KW - analysi KW - analysis KW - application KW - applications KW - AS KW - at KW - Commercialization KW - composition KW - data KW - Database KW - Decision KW - detection KW - detection method KW - Development KW - Dna KW - effective KW - genetically KW - Genetically modified KW - genetically modified plant KW - Genetically modified plants KW - Genome KW - GMO KW - GMO detection KW - GMOs KW - GMOseek KW - GMOseek matrix KW - INFORMATION KW - IS KW - matrix KW - method KW - methods KW - occurrence KW - ON KW - ORIGIN KW - plant KW - plant origin KW - Plants KW - PRODUCTS KW - result KW - results KW - SCREENING KW - specific KW - status KW - Strategies KW - Strategy KW - Target KW - Targets KW - Transgene KW - use AB - Background: Since their first commercialization, the diversity of taxa and the genetic composition of transgenesequences in genetically modified plants (GMOs) are constantly increasing. To date, the detection of GMOs andderived products is commonly performed by PCR-based methods targeting specific DNA sequences introducedinto the host genome. Information available regarding the GMOs' molecular characterization is dispersed and notappropriately organized. For this reason, GMO testing is very challenging and requires more complex screeningstrategies and decision making schemes, demanding in return the use of efficient bioinformatics tools relying onreliable information.Description: The GMOseek matrix was built as a comprehensive, online open-access tabulated database whichprovides a reliable, comprehensive and user-friendly overview of 328 GMO events and 247 different geneticelements (status: 18/07/2013). The GMOseek matrix is aiming to facilitate GMO detection from plant origin atdifferent phases of the analysis. It assists in selecting the targets for a screening analysis, interpreting the screeningresults, checking the occurrence of a screening element in a group of selected GMOs, identifying gaps in theavailable pool of GMO detection methods, and designing a decision tree. The GMOseek matrix is an independentdatabase with effective functionalities in a format facilitating transferability to other platforms. Data were collectedfrom all available sources and experimentally tested where detection methods and certified reference materials(CRMs) were available.Conclusions: The GMOseek matrix is currently a unique and very valuable tool with reliable information on GMOsfrom plant origin and their present genetic elements that enables further development of appropriate strategies forGMO detection. It is flexible enough to be further updated with new information and integrated in differentapplications and platforms. VL - 14 CP - 256 U1 - 35191 M3 - http://dx.doi.org/10.1186/1471-2105-14-256 ER - TY - RPRT T1 - Advanced Analysis of Real Time PCR data Y1 - 2012 A1 - A. Lievens A1 - S. Van Aelst A1 - Marc Van den Bulcke A1 - Goetghebeur,E. A1 - Nancy Roosens KW - analysi KW - analysis KW - data KW - PCR KW - real time PCR KW - time PB - WIV-ISP CY - Brussels, Belgium VL - 2010-2011 SN - ISSN D/2012/2505/19 U1 - 38801 ER - TY - JOUR T1 - Detecting un-authorized genetically modified organisms (GMOs) and derived materials4841 JF - Biotechnol.Adv. Y1 - 2012 A1 - Holst-Jensen,A. A1 - Bertheau,Y. A1 - M. De Loose A1 - L. Grohmann A1 - Hamels,S. A1 - Hougs,L. A1 - Morisset,D. A1 - Pecoraro,S. A1 - Pla,M. A1 - Marc Van den Bulcke A1 - Wulff,D. KW - 2010 KW - a KW - ALL KW - approach KW - approaches KW - AS KW - bias KW - Commercialization KW - Control KW - Countries KW - Coverage KW - data KW - detection KW - Development KW - dissemination KW - diversity KW - EU KW - European KW - European Union KW - factors KW - Field KW - GEM KW - Genetic KW - genetically KW - Genetically engineered organism KW - Genetically modified KW - Genetically modified organism KW - Genetically modified organisms KW - genetically modified plant KW - Genetically modified plants KW - global KW - GMO KW - GMO screening KW - GMOs KW - identify KW - INFORMATION KW - Institute KW - IS KW - IT KW - Laboratories KW - legal KW - Light KW - limitation KW - Limitations KW - maize KW - Matrix approach KW - Norway KW - norwegian KW - Observation KW - OECD KW - ON KW - Paper KW - period KW - plant KW - Plants KW - present KW - production KW - relevance KW - REVIEW KW - SENSITIVITY KW - Soybean KW - specific KW - State KW - technology KW - Term KW - time KW - Un-approved GEM KW - Un-approved GMO KW - unauthorized GMO KW - Unknown GMO AB - Genetically modified plants, in the following referred to as genetically modified organisms or GMOs, have been commercially grown for almost two decades. In 2010 approximately 10% of the total global crop acreage was planted with GMOs (James, 2011). More than 30 countries have been growing commercial GMOs, and many more have performed field trials. Although the majority of commercial GMOs both in terms of acreage and specific events belong to the four species: soybean, maize, cotton and rapeseed, there are another 20+ species where GMOs are commercialized or in the pipeline for commercialization. The number of GMOs cultivated in field trials or for commercial production has constantly increased during this time period. So have the number of species, the number of countries involved, the diversity of novel (added) genetic elements and the global trade. All of these factors contribute to the increasing complexity of detecting and correctly identifying GMO derived material. Many jurisdictions, including the European Union (EU), legally distinguish between authorized (and therefore legal) and un-authorized (and therefore illegal) GMOs. Information about the developments, field trials, authorizations, cultivation, trade and observations made in the official GMO control laboratories in different countries around the world is often limited, despite several attempts such as the OECD BioTrack for voluntary dissemination of data. This lack of information inevitably makes it challenging to detect and identify GMOs, especially the un-authorized GMOs. The present paper reviews the state of the art technologies and approaches in light of coverage, practicability, sensitivity and limitations. Emphasis is put on exemplifying practical detection of un-authorized GMOs. Although this paper has a European (EU) bias when examples are given, the contents have global relevance VL - On line U1 - 4841 M3 - 10.1016/j.biotechadv.2012.01.024 ER - TY - BOOK T1 - Development of a molecular platform for GMO detection in food and feed on the basis of "combinatory qPCR" technology4843 T2 - Polymerase Chain Reaction Y1 - 2012 A1 - Sylvia Broeders A1 - N. Papazova A1 - Marc Van den Bulcke A1 - Nancy Roosens ED - Patricia Hernandez-Gomez KW - a KW - detection KW - Development KW - feed KW - food KW - GMO KW - GMO detection KW - Molecular KW - ON KW - polymerase chain reaction KW - technology JF - Polymerase Chain Reaction PB - =InTech CY - Janeza Trdine 9, 51000 Rijeka, Croatia SN - ISBN 978-953-51-0612-8 CP - 18 U1 - 4843 M3 - DOI: 10.5772/37898 ER - TY - JOUR T1 - Enhanced analysis of real-time PCR data by using a variable efficiency model: FPK-PCR. JF - Nucleic Acids Res Y1 - 2012 A1 - Lievens, Antoon A1 - Van Aelst, S A1 - Marc Van den Bulcke A1 - Goetghebeur, E KW - DNA, Plant KW - Fluorescence KW - Kinetics KW - Logistic Models KW - Real-Time Polymerase Chain Reaction KW - Soybeans AB -

Current methodology in real-time Polymerase chain reaction (PCR) analysis performs well provided PCR efficiency remains constant over reactions. Yet, small changes in efficiency can lead to large quantification errors. Particularly in biological samples, the possible presence of inhibitors forms a challenge. We present a new approach to single reaction efficiency calculation, called Full Process Kinetics-PCR (FPK-PCR). It combines a kinetically more realistic model with flexible adaptation to the full range of data. By reconstructing the entire chain of cycle efficiencies, rather than restricting the focus on a 'window of application', one extracts additional information and loses a level of arbitrariness. The maximal efficiency estimates returned by the model are comparable in accuracy and precision to both the golden standard of serial dilution and other single reaction efficiency methods. The cycle-to-cycle changes in efficiency, as described by the FPK-PCR procedure, stay considerably closer to the data than those from other S-shaped models. The assessment of individual cycle efficiencies returns more information than other single efficiency methods. It allows in-depth interpretation of real-time PCR data and reconstruction of the fluorescence data, providing quality control. Finally, by implementing a global efficiency model, reproducibility is improved as the selection of a window of application is avoided.

VL - 40 CP - 2 U1 - http://www.ncbi.nlm.nih.gov/pubmed/22102586?dopt=Abstract M3 - 10.1093/nar/gkr775 ER - TY - JOUR T1 - Four new SYBR®Green qPCR screening methods for the detection of Roundup Ready(r), LibertyLink(r), and CryIAb traits in genetically modified products362 JF - Eur Food Res Technol Y1 - 2012 A1 - E. Barbau-Piednoir A1 - A. Lievens A1 - Els Vandermassen A1 - G.E. Mbongolo-Mbella A1 - Amaya Leunda A1 - Nancy Roosens A1 - Myriam Sneyers A1 - Marc Van den Bulcke KW - a KW - ALL KW - an KW - analysi KW - analysis KW - application KW - AS KW - at KW - Bacillus KW - Bacillus thuringiensis KW - Cost KW - COSTS KW - CoSYPS KW - detection KW - Efficiency KW - Feed/food analysis KW - genetically KW - Genetically modified KW - Genetically modified organism KW - Genetically modified organisms KW - global KW - GM KW - GMO KW - GMO detection KW - Herbicide resistance KW - identification KW - Insect resistance KW - IS KW - LEVEL KW - levels KW - method KW - methods KW - PCR KW - present KW - PRODUCTS KW - qPCR KW - Quantitative real-time PCR KW - r KW - RANGE KW - result KW - results KW - Sample KW - Samples KW - SCREENING KW - Screening method KW - SENSITIVITY KW - specific KW - specificity KW - SYBR(r)Green KW - SYBRgreen KW - Target KW - Targets KW - Test KW - Traits AB - SYBR(r)Green qPCR methods for the detection of the Roundup Ready (r) "CP4-EPSPS", LibertyLink (r) "PAT" and "BAR" and the Bacillus thuringiensis "CryIAb" traits as present in genetically modified organisms (GMO) were developed. Their specificity, sensitivity, and PCR method efficiency were determined. All methods are specific and generate amplicons of 108, 73, 109, and 69 bp, respectively, for "CP4-EPSPS", "CryIAb", "PAT" and "BAR" targets. They perform well at low target levels and can detect down to 5 copies of their respective targets extracted from a sample. The PCR efficiency of the methods ranges between 91 and 109%. Due to their trait-specific nature, these methods allow an efficient screening between the different GMO. In this way, the number of possible GMO candidates present in a sample can be reduced what results in lower global costs due to limiting of further the number of analytical identification steps. The application of these methods in CoSYPS GMO analysis is illustrated using two GEMMA proficiency test samples and a reference material from the GM rapeseed event RF3. This set of SYBR(r)Green qPCR trait-specific methods represents a very interesting novel set of GMO analysis methods allowing cost-effective identification of GM materials in products. VL - 234 SN - 1438-2377 CP - 1 U1 - 38507 M3 - DOI: 10.1007/s00217-011-1605-7 ER - TY - BOOK T1 - The modular approach in GMO quality control and enforcement support systems.453 T2 - Genetically Modified and Non-Genetically Modified Food Supply Chains. Co-existence and traceability. Y1 - 2012 A1 - Marc Van den Bulcke A1 - Bellocchi,G. A1 - Berben,G. A1 - Burns,M. A1 - Kankar,K. A1 - De Giacomo,M. A1 - Kristina Gruden A1 - Holst-Jensen,A. A1 - Malcewsky,A. A1 - Mazzara,M. A1 - Onori,R. A1 - N. Papazova A1 - Parlouer,E A1 - Isabel Taverniers A1 - Trapmann,S. A1 - Wulff,D. A1 - Zhang,D. ED - Bertheau,Y. KW - approach KW - approaches KW - co-existence KW - coexistence KW - Control KW - food KW - Food Supply KW - genetically KW - Genetically modified KW - GMO KW - modular KW - Quality KW - Quality Control KW - System KW - Systems KW - traceability JF - Genetically Modified and Non-Genetically Modified Food Supply Chains. Co-existence and traceability. PB - Wiley-Blackwell CY - ="UK" SN - 987-1-4443-37778-5 CP - 4 U1 - 39015 M3 - not availabel ER - TY - JOUR T1 - Simulation of between repeat variability in real time PCR reactions. JF - PLoS One Y1 - 2012 A1 - Lievens, Antoon A1 - Van Aelst, Stefan A1 - Marc Van den Bulcke A1 - Goetghebeur, Els KW - Algorithms KW - Analysis of Variance KW - Computer Simulation KW - Models, Statistical KW - Real-Time Polymerase Chain Reaction KW - Reproducibility of Results KW - Sensitivity and Specificity AB -

While many decisions rely on real time quantitative PCR (qPCR) analysis few attempts have hitherto been made to quantify bounds of precision accounting for the various sources of variation involved in the measurement process. Besides influences of more obvious factors such as camera noise and pipetting variation, changing efficiencies within and between reactions affect PCR results to a degree which is not fully recognized. Here, we develop a statistical framework that models measurement error and other sources of variation as they contribute to fluorescence observations during the amplification process and to derived parameter estimates. Evaluation of reproducibility is then based on simulations capable of generating realistic variation patterns. To this end, we start from a relatively simple statistical model for the evolution of efficiency in a single PCR reaction and introduce additional error components, one at a time, to arrive at stochastic data generation capable of simulating the variation patterns witnessed in repeated reactions (technical repeats). Most of the variation in C(q) values was adequately captured by the statistical model in terms of foreseen components. To recreate the dispersion of the repeats' plateau levels while keeping the other aspects of the PCR curves within realistic bounds, additional sources of reagent consumption (side reactions) enter into the model. Once an adequate data generating model is available, simulations can serve to evaluate various aspects of PCR under the assumptions of the model and beyond.

VL - 7 CP - 11 U1 - http://www.ncbi.nlm.nih.gov/pubmed/23189123?dopt=Abstract M3 - 10.1371/journal.pone.0047112 ER - TY - JOUR T1 - Towards a Pathogenic Escherichia coli Detection Platform Using Multiplex SYBR(R)Green Real-Time PCR Methods and High Resolution Melting Analysis418 JF - PLoS.One. Y1 - 2012 A1 - Kagkli,D.M. A1 - Folloni,S. A1 - E. Barbau-Piednoir A1 - Van den Eede,G. A1 - Marc Van den Bulcke KW - a KW - ALL KW - analysi KW - analysis KW - application KW - article KW - at KW - Attention KW - bacteria KW - Biology KW - Case KW - consumer KW - detection KW - detection method KW - developing KW - Development KW - discrimination KW - disease KW - Diseases KW - dye KW - e KW - electronic KW - Escherichia coli KW - European KW - European Commission KW - food KW - Food Safety KW - gene KW - Genes KW - genomic KW - Genomics KW - Germany KW - Group KW - health KW - HRM KW - im KW - Institute KW - IS KW - ITALY KW - journal KW - method KW - methods KW - Molecular KW - Molecular biology KW - Monitoring KW - need KW - Order KW - outbreak KW - outbreaks KW - pathogenic KW - PCR KW - protection KW - protein KW - real time PCR KW - Real-time PCR KW - report KW - Research KW - SAFETY KW - Sample KW - Samples KW - SB - IM KW - Shiga Toxin KW - STEC KW - strain KW - SYBR(r)Green KW - Temperature KW - toxin KW - Traits KW - use KW - virulence KW - VTEC AB - Escherichia coli is a group of bacteria which has raised a lot of safety concerns in recent years. Five major intestinal pathogenic groups have been recognized amongst which the verocytotoxin or shiga-toxin (stx1 and/or stx2) producing E. coli (VTEC or STEC respectively) have received a lot of attention recently. Indeed, due to the high number of outbreaks related to VTEC strains, the European Food Safety Authority (EFSA) has requested the monitoring of the "top-five" serogroups (O26, O103, O111, O145 and O157) most often encountered in food borne diseases and addressed the need for validated VTEC detection methods. Here we report the development of a set of intercalating dye Real-time PCR methods capable of rapidly detecting the presence of the toxin genes together with intimin (eae) in the case of VTEC, or aggregative protein (aggR), in the case of the O104:H4 strain responsible for the outbreak in Germany in 2011. All reactions were optimized to perform at the same annealing temperature permitting the multiplex application in order to minimize the need of material and to allow for high-throughput analysis. In addition, High Resolution Melting (HRM) analysis allowing the discrimination among strains possessing similar virulence traits was established. The development, application to food samples and the flexibility in use of the methods are thoroughly discussed. Together, these Real-time PCR methods facilitate the detection of VTEC in a new highly efficient way and could represent the basis for developing a simple pathogenic E. coli platform VL - 7 CP - 6 U1 - 418 M3 - 10.1371/journal.pone.0039287 [doi];PONE-D-12-04306 [pii] ER - TY - JOUR T1 - Application of the Modular Approach to an In-House Validation Study of Real-Time PCR Methods for the Detection and Serogroup Determination of Verocytotoxigenic Escherichia coli4844 JF - Appl.Environ.Microbiol. Y1 - 2011 A1 - Kagkli,D.M. A1 - Weber,T.P. A1 - Marc Van den Bulcke A1 - Folloni,S. A1 - Tozzoli,R. A1 - Morabito,S. A1 - Ermolli,M. A1 - Gribaldo,L. A1 - Van den Eede,G. KW - a KW - Agent KW - Agents KW - an KW - application KW - approach KW - approaches KW - AS KW - Biology KW - cause KW - conditions KW - consumer KW - CONSUMPTION KW - Control KW - criteria KW - detection KW - e KW - Efficiency KW - electronic KW - Escherichia coli KW - European KW - European Commission KW - food KW - Food Microbiology KW - Food Safety KW - gene KW - Genes KW - genomic KW - Genomics KW - hazard KW - health KW - Human KW - Indicator KW - INFECTION KW - infections KW - Institute KW - IS KW - ITALY KW - journal KW - Laboratories KW - Limit of Detection KW - method KW - methods KW - microbiology KW - modular KW - Molecular KW - Molecular biology KW - Monitoring KW - ON KW - outbreak KW - outbreaks KW - parameters KW - PCR KW - performance KW - Plasmids KW - PROCESSES KW - protection KW - RANGE KW - real time PCR KW - Real-time PCR KW - regulation KW - Research KW - SAFETY KW - specificity KW - strain KW - study KW - toxin KW - VALIDATION KW - Validation study KW - VTEC AB - European Commission regulation 2073/2005 on the microbiological criteria for food requires that Escherichia coli is monitored as an indicator of hygienic conditions. Since verocytotoxigenic E. coli (VTEC) strains often cause food-borne infections by the consumption of raw food, the Biological Hazards (BIOHAZ) panel of the European Food Safety Authority (EFSA) recommended their monitoring in food as well. In particular, VTEC strains belonging to serogroups such as O26, O103, O111, O145, and O157 are known causative agents of several human outbreaks. Eight real-time PCR methods for the detection of E. coli toxin genes and their variants (stx(1), stx(2)), the intimin gene (eae), and five serogroup-specific genes have been proposed by the European Reference Laboratory for VTEC (EURL-VTEC) as a technical specification to the European Normalization Committee (CEN TC275/WG6). Here we applied a "modular approach" to the in-house validation of these PCR methods. The modular approach subdivides an analytical process into separate parts called "modules," which are independently validated based on method performance criteria for a limited set of critical parameters. For the VTEC real-time PCR module, the following parameters are being assessed: specificity, dynamic range, PCR efficiency, and limit of detection (LOD). This study describes the modular approach for the validation of PCR methods to be used in food microbiology, using single-target plasmids as positive controls and showing their applicability with food matrices VL - 77 CP - 19 U1 - 4844 M3 - AEM.05357-11 [pii];10.1128/AEM.05357-11 [doi] ER - TY - JOUR T1 - SYBR®Green qPCR methods for detection of endogenous reference genes in commodity crops: a step ahead in combinatory screening of Genetically Modified Crops in food and feed products JF - Eur.Food Res.Technol. Y1 - 2011 A1 - G.E. Mbongolo-Mbella A1 - A. Lievens A1 - E. Barbau-Piednoir A1 - Myriam Sneyers A1 - Amaya Leunda A1 - Nancy Roosens A1 - Marc Van den Bulcke KW - an KW - approach KW - approaches KW - at KW - Biomedical and Life Sciences KW - criteria KW - crops KW - detection KW - Development KW - Efficiency KW - EU KW - European KW - European Union KW - feed KW - food KW - gene KW - Genes KW - Genetically modified KW - Genetically modified crop KW - genetically modified crops KW - Genetically modified organism KW - Genetically modified organisms KW - GMO KW - IS KW - Laboratories KW - maize KW - method KW - methods KW - Network KW - Oilseed rape KW - Order KW - PCR KW - performance KW - polymerase chain reaction KW - PRODUCTS KW - qPCR KW - SCREENING KW - Soybean KW - Strategies KW - Strategy KW - sugar AB - Identification of crops present in food and/or feed matrices represents an important step in the screening strategies targeting genetically modified organisms (GMO). Soybean, maize, oilseed rape, rice, cotton, sugar beet and potato are to date the most important sources of genetically modified materials imported in the European Union (EU). In order to allow detection of their presence in an integrated screening approach, a set of SYBR-«Green real-time polymerase chain reaction (qPCR) methods has been developed which can be used under the same assay conditions and at similar efficiency for each of the abovementioned crops. Each qPCR method is shown to meet the performance criteria (i.e. specificity, limit of detection and PCR efficiency) set by the European Network of GMO Laboratories (ENGL). When combined with the equivalent qPCR methods targeting GMO elements, these crop-specific SYBR-«Green qPCR methods can aid the development of an efficient tool for determining GMO presence in food and/or feed products VL - 232 SN - 14382377 CP - 3 U1 - 345 M3 - http://dx.doi.org/10.1007/s00217-010-1408-2 ER - TY - RPRT T1 - Development of a molecular detection platform for GMO detection in food based on "combinatory qPCR" technology Y1 - 2010 A1 - Nancy Roosens A1 - E. Barbau-Piednoir A1 - A. Lievens A1 - G.E. Mbongolo-Mbella A1 - D. Van Geel A1 - Els Vandermassen A1 - Amaya Leunda A1 - Sylvia Broeders A1 - Myriam Sneyers A1 - Marc Van den Bulcke KW - a KW - detection KW - Development KW - food KW - GMO KW - GMO detection KW - Molecular KW - molecular detection KW - ON KW - technology PB - WIV-ISP; PBB CY - Brussels, Belgium SN - D/2010/2505/52 U1 - 38867 ER - TY - JOUR T1 - New approaches in GMO detection399 JF - Anal.Bioanal.Chem. Y1 - 2010 A1 - Querci,M. A1 - Marc Van den Bulcke A1 - Jana Zel A1 - Van den Eede,G. A1 - Broll,H. KW - a KW - Algorithms KW - an KW - analysi KW - analysis KW - approach KW - approaches KW - aspects KW - at KW - Biology KW - challenge KW - consumer KW - Control KW - Countries KW - decision support systems KW - detection KW - detection strategies KW - Development KW - Diffusion KW - European KW - future KW - gene KW - Genes KW - Genetic KW - genetically KW - Genetically modified KW - Genetically modified organism KW - Genetically modified organisms KW - genetically modified plant KW - Genetically modified plants KW - genomic KW - Genomics KW - GMO KW - GMO detection KW - GMOs KW - health KW - high-throughput systems KW - Institute KW - IS KW - IT KW - ITALY KW - M KW - Matrix approach KW - Molecular KW - Molecular biology KW - Multiple KW - ON KW - Paper KW - plant KW - Plants KW - present KW - protection KW - Requirements KW - Research KW - result KW - results KW - REVIEW KW - Sample KW - Selection KW - Strategies KW - Strategy KW - System KW - Systems KW - Target KW - Targets KW - technology KW - TESTING KW - time KW - use AB - The steady rate of development and diffusion of genetically modified plants and their increasing diversification of characteristics, genes and genetic control elements poses a challenge in analysis of genetically modified organisms (GMOs). It is expected that in the near future the picture will be even more complex. Traditional approaches, mostly based on the sequential detection of one target at a time, or on a limited multiplexing, allowing only a few targets to be analysed at once, no longer meet the testing requirements. Along with new analytical technologies, new approaches for the detection of GMOs authorized for commercial purposes in various countries have been developed that rely on (1) a smart and accurate strategy for target selection, (2) the use of high-throughput systems or platforms for the detection of multiple targets and (3) algorithms that allow the conversion of analytical results into an indication of the presence of individual GMOs potentially present in an unknown sample. This paper reviews the latest progress made in GMO analysis, taking examples from the most recently developed strategies and tools, and addresses some of the critical aspects related to these approaches. VL - 396 SN - online ISSN 1618-2650 - print ISSN 1618-2642 CP - 6 U1 - 399 M3 - 10.1007/s00216-009-3237-3 ER - TY - Generic T1 - NRL-GMO: GMODetec research project (2007-2010)408 Y1 - 2010 A1 - E. Barbau-Piednoir A1 - A. Lievens A1 - Amaya Leunda A1 - Nancy Roosens A1 - Marc Van den Bulcke A1 - Myriam Sneyers A1 - Frédéric Debode A1 - Jansens,E. A1 - Berben,G. A1 - Ruttink,T. A1 - Isabel Taverniers A1 - M. De Loose KW - abstract KW - GMO KW - Project KW - Research AB - No abstract JF - LabInfo VL - 5 CP - December 2010 U1 - 38491 ER - TY - JOUR T1 - SYBR®Green qPCR screening methods for the presence of "35S promoter" and "NOS terminator" elements in food and feed products400 JF - Eur.Food.Res.Technol. Y1 - 2010 A1 - E. Barbau-Piednoir A1 - A. Lievens A1 - G.E. Mbongolo-Mbella A1 - Nancy Roosens A1 - Myriam Sneyers A1 - Amaya Leunda A1 - Marc Van den Bulcke KW - 35S promotor KW - a KW - at KW - Belgium KW - biosafety KW - Biotechnology KW - Brussels KW - crops KW - Efficiency KW - feed KW - food KW - food and feed analysis KW - genetically KW - Genetically modified KW - Genetically modified crop KW - genetically modified crops KW - GMO detection KW - health KW - Institute KW - LEVEL KW - levels KW - low level KW - M KW - method KW - methods KW - n KW - NOS terminator KW - PCR KW - Plasmids KW - PRODUCTS KW - public KW - public health KW - Public-health KW - qPCR KW - recombinant KW - SBB KW - SCREENING KW - Screening method KW - Short KW - specific KW - SYBR(r)Green KW - Target KW - Targets KW - Temperature KW - VIRUS AB - The Cauliflower Mosaic Virus "35S promotor" (p35S) and the Agrobacterium "Nopaline Synthase" terminator (tNOS) are the most represented generic recombinant elements in commercial genetically modified crops to date. A set of four new SYBR VL - 230 SN - 14382377 CP - 3 U1 - 38490 M3 - 10.1007/s00217-009-1170-5 ER - TY - JOUR T1 - A theoretical introduction to "combinatory SYBRGreen qPCR screening", a matrix-based approach for the detection of materials derived from genetically modified plants. JF - Anal Bioanal Chem Y1 - 2010 A1 - Marc Van den Bulcke A1 - Lievens, Antoon A1 - Barbau-Piednoir, Elodie A1 - Guillaume Mbongolo Mbella A1 - Nancy Roosens A1 - Myriam Sneyers A1 - Amaya Leunda KW - Algorithms KW - Animal Feed KW - Fluorescent Dyes KW - Food Analysis KW - Food, Genetically Modified KW - Models, Theoretical KW - Organic Chemicals KW - Plants, Genetically Modified KW - polymerase chain reaction AB -

The detection of genetically modified (GM) materials in food and feed products is a complex multi-step analytical process invoking screening, identification, and often quantification of the genetically modified organisms (GMO) present in a sample. "Combinatory qPCR SYBRGreen screening" (CoSYPS) is a matrix-based approach for determining the presence of GM plant materials in products. The CoSYPS decision-support system (DSS) interprets the analytical results of SYBRGREEN qPCR analysis based on four values: the C(t)- and T(m) values and the LOD and LOQ for each method. A theoretical explanation of the different concepts applied in CoSYPS analysis is given (GMO Universe, "Prime number tracing", matrix/combinatory approach) and documented using the RoundUp Ready soy GTS40-3-2 as an example. By applying a limited set of SYBRGREEN qPCR methods and through application of a newly developed "prime number"-based algorithm, the nature of subsets of corresponding GMO in a sample can be determined. Together, these analyses provide guidance for semi-quantitative estimation of GMO presence in a food and feed product.

VL - 396 CP - 6 U1 - http://www.ncbi.nlm.nih.gov/pubmed/19960341?dopt=Abstract M3 - 10.1007/s00216-009-3286-7 ER - TY - JOUR T1 - Use of pJANUS-02-001 as a calibrator plasmid for Roundup Ready soybean event GTS-40-3-2 detection: an interlaboratory trial assessment. JF - Anal Bioanal Chem Y1 - 2010 A1 - Lievens, A A1 - Bellocchi, G A1 - De Bernardi, D A1 - William Moens A1 - Savini, C A1 - Mazzara, M A1 - Van den Eede, G A1 - Marc Van den Bulcke KW - Animal Feed KW - Calibration KW - Plant Lectins KW - Plants, Genetically Modified KW - Plasmids KW - polymerase chain reaction KW - Soybean Proteins KW - Soybeans AB -

Owing to the labelling requirements of food and feed products containing materials derived from genetically modified organisms, quantitative detection methods have to be developed for this purpose, including the necessary certified reference materials and calibrator standards. To date, for most genetically modified organisms authorized in the European Union, certified reference materials derived from seed powders are being developed. Here, an assessment has been made on the feasibility of using plasmid DNA as an alternative calibrator for the quantitative detection of genetically modified organisms. For this, a dual-target plasmid, designated as pJANUS-02-001, comprising part of a junction region of genetically modified soybean event GTS-40-3-2 and the endogenous soybean-specific lectin gene was constructed. The dynamic range, efficiency and limit of detection for the soybean event GTS-40-3-2 real-time quantitative polymerase chain reaction (Q-PCR) system described by Terry et al. (J AOAC Int 85(4):938-944, 2002) were shown to be similar for in house produced homozygous genomic DNA from leaf tissue of soybean event GTS-40-3-2 and for plasmid pJANUS-02-001 DNA backgrounds. The performance of this real-time Q-PCR system using both types of DNA templates as calibrator standards in quantitative DNA analysis was further assessed in an interlaboratory trial. Statistical analysis and fuzzy-logic-based interpretation were performed on critical method parameters (as defined by the European Network of GMO Laboratories and the Community Reference Laboratory for GM Food and Feed guidelines) and demonstrated that the plasmid pJANUS-02-001 DNA represents a valuable alternative to genomic DNA as a calibrator for the quantification of soybean event GTS-40-3-2 in food and feed products.

VL - 396 CP - 6 U1 - http://www.ncbi.nlm.nih.gov/pubmed/20016879?dopt=Abstract M3 - 10.1007/s00216-009-3346-z ER - TY - Generic T1 - Co-Extra: Europees project over co-existentie en traceerbaarheid van GGO en niet-GGO productieketens Y1 - 2009 A1 - Didier Breyer A1 - Nancy Roosens A1 - Berben,G. A1 - Isabel Taverniers A1 - Marc Van den Bulcke A1 - Myriam Sneyers KW - Co-Extra KW - coexistence KW - de KW - GMO KW - IS KW - production KW - SBB KW - SIGMEA AB - Co-Extra is een Europees project dat in april 2005 van start ging en in september 2009 wordt beëindigd. Er werkenmeer dan 200 wetenschappers aan mee die verbonden zijn aan 51 multidisciplinaire onderzoeksteams en eenaantal privé-bedrijven uit 18 landen (Europa, Brazilië, Argentinië en Rusland). Het project beschikt over een totaalbudget van 22 miljoen euro, waarvan 13 miljoen wordt betaald door de Europese Commissie via een fi nancieringsregelingvoor het 6de Europese kaderprogramma voor onderzoek.De belangrijkste doelstelling van Co-Extra bestaat erin de tools te verstrekken die nodig zijn voor de implementatievan co-existentie en traceerbaarheid met als doel de co-existentie van productieketens met GGO-producten,met gangbare producten of met producten uit de biologische landbouw te garanderen. Dit geïntegreerdeproject vormt een aanvulling op twee andere Europese projecten : SIGMEA dat vooral betrekking heeft op deco-existentie op het niveau van de landbouwproductie en Transcontainer dat zich toespitst op "biocontainment". JF - LabInfo VL - 3 CP - November 2009 U1 - 2806 ER - TY - Generic T1 - Co-Extra: Projet européen sur la coexistence et la traçabilité des filières OGM et non-OGM Y1 - 2009 A1 - Didier Breyer A1 - Nancy Roosens A1 - Berben,G. A1 - Isabel Taverniers A1 - Marc Van den Bulcke A1 - Myriam Sneyers KW - Co-Extra KW - coexistence KW - de KW - Europe KW - GMO KW - LE KW - OGM KW - production KW - programme KW - SBB KW - SIGMEA AB - Co-Extra est un projet européen qui a débuté en avril 2005 et fi nira en septembre 2009. Il regroupe plus de 200scientifi ques appartenant à 51 équipes de recherche multidisciplinaires ainsi que plusieurs compagnies privées,provenant de 18 pays (Europe, Brésil, Argentine et Russie). Le projet dispose d'un budget total de 22 millionsd'euros dont 13 millions à charge de la Commission européenne via un fi nancement lié au 6ème programme-cadrede recherche communautaire.L'objectif principal de Co-Extra est de fournir les outils nécessaires à l'implémentation de la coexistence et de latraçabilité en vue d'assurer la coexistence des fi lières utilisant des produits OGM, conventionnels ou dérivés del'agriculture biologique. Ce projet intégré complète deux autres programmes européens: SIGMEA qui porte principalementsur la coexistence au niveau de la production agricole et Transcontainer focalisé sur les méthodes debioconfi nement. JF - LabInfo VL - 3 CP - Novembre 2009 U1 - 2804 ER - TY - Generic T1 - European project Co-Extra: GM and non-GM supply chains: their co-existence and traceability Y1 - 2009 A1 - Didier Breyer A1 - Nancy Roosens A1 - Berben,G. A1 - Isabel Taverniers A1 - Marc Van den Bulcke A1 - Myriam Sneyers KW - abstract KW - co-existence KW - Co-Extra KW - coexistence KW - European KW - GM KW - GMO KW - Project KW - traceability AB -

No abstract

JF - LabInfo PB - xx CY - Brussels VL - 3 U1 - 363 ER - TY - Generic T1 - Matrix Approach in GMO analysis Y1 - 2009 A1 - Marc Van den Bulcke KW - analysi KW - analysis KW - approach KW - approaches KW - ENGL KW - GMO KW - matrix KW - Matrix approach KW - meeting JF - ENGL meeting PB - NA CY - NA CP - Co-extra project commit, e U1 - 365 U2 - 22/04/2009 ER - TY - Generic T1 - Modular Approach Implemented: Pros, Cons and Future Perspectives Y1 - 2009 A1 - Marc Van den Bulcke A1 - Bellocchi,G. A1 - Berben,G. A1 - Burns,M. A1 - Cankar,K. A1 - De Giacomo,M. A1 - Kristina Gruden A1 - Holst-Jensen,A. A1 - Malcewsky,A. A1 - Mazzara,M. A1 - Onori,R. A1 - N. Papazova A1 - Parlouer,E A1 - Isabel Taverniers A1 - Wulff,D. A1 - Zhang,D. KW - approach KW - approaches KW - Co-Extra KW - Congresses KW - future KW - International KW - modular JF - Co-extra International Congress PB - NA CY - NA CP - Co-extra International Congress U1 - 377 U2 - 03/06/2009 ER - TY - Generic T1 - Towards an integrated Real-Time Q-PCR platform for GMO detection at low level presence Y1 - 2009 A1 - A. Lievens A1 - Amaya Leunda A1 - Piednoir,E. A1 - Myriam Sneyers A1 - Marc Van den Bulcke KW - an KW - at KW - Co-Extra KW - Congresses KW - detection KW - GMO KW - GMO detection KW - International KW - LEVEL KW - low level KW - qPCR JF - Co-extra International Congress PB - NA CY - NA CP - Co-extra International Congress U1 - 376 U2 - 03/06/2009 ER - TY - Generic T1 - Use of pJANUS-02-001 as calibrator plasmid for GTS40-3-2 (Roundup Ready soybean) detection: an inter-laboratory trial assessment Y1 - 2009 A1 - A. Lievens A1 - De Bernardi,D. A1 - William Moens A1 - Marc Van den Bulcke A1 - Bellocchi,G. A1 - Savini,C. A1 - Mazzara,M. A1 - Van den Eede,G. KW - an KW - AS KW - assessment KW - Co-Extra KW - Congresses KW - detection KW - International KW - Soybean KW - use JF - Co-extra International Congress PB - NA CY - NA CP - Co-extra project committee U1 - 375 U2 - 30/06/2009 ER - TY - Generic T1 - Codex alimentarius Y1 - 2008 A1 - Marc Van den Bulcke KW - alimentation KW - Communication KW - de JF - Groupe de communication NRL PB - NA CY - NA CP - NRL U1 - 386 U2 - 30/10/2008 ER - TY - Generic T1 - Combinatory SYBR®Green Real-Time PCR screening as a risk management tool for low level presence of materials derived from Genetically Modified Plants384 Y1 - 2008 A1 - E. Barbau-Piednoir A1 - Els Vandermassen A1 - D. Van Geel A1 - Marc Van den Bulcke A1 - Nancy Roosens ED - Co-extra project committee KW - a KW - AS KW - Co-Extra KW - combinatory KW - conference KW - genetically KW - Genetically modified KW - genetically modified plant KW - Genetically modified plants KW - LEVEL KW - low level KW - management KW - PCR KW - plant KW - Plants KW - real time PCR KW - Real-time PCR KW - risk KW - risk management KW - SCREENING JF - Final CO-EXTRA conference CP - CO-EXTRA project comittee U1 - 384 U2 - 2008 ER - TY - Generic T1 - COSYPS: Combinatory SybrGreen Screening for FM food and Feed. Y1 - 2008 A1 - Marc Van den Bulcke ED - ENGL KW - combinatory KW - CoSYPS KW - ENGL KW - feed KW - food KW - meeting KW - SCREENING KW - SYBRgreen JF - ENGL meeting CP - ENGL U1 - 389 U2 - 13/11/2008 ER - TY - Generic T1 - Development of an integrated platform for the detetcion of materials derived from Genetically Modified Crops in food and feed products Y1 - 2008 A1 - Marc Van den Bulcke KW - an KW - analysi KW - analysis KW - conference KW - crops KW - Development KW - feed KW - food KW - genetically KW - Genetically modified KW - Genetically modified crop KW - genetically modified crops KW - global KW - GMO KW - ON KW - PRODUCTS JF - 1st Global Conference on GMO analysis PB - NA CY - NA CP - JRC European Commission U1 - 385 U2 - 24/06/2008 ER - TY - Generic T1 - Effect of different storage conditions on PCR amplificability of genomic DNA extracted from pellets containing maize MON 810 maize Y1 - 2008 A1 - Piednoir,E. A1 - Els Vandermassen A1 - D. Van Geel A1 - Marc Van den Bulcke A1 - Nancy Roosens ED - Co-extra project committee KW - Co-Extra KW - conditions KW - conference KW - Dna KW - effect KW - genomic KW - maize KW - ON KW - PCR KW - STORAGE JF - Final CO-EXTRA conference CP - CO-EXTRA project comittee U1 - 391 U2 - 2008 ER - TY - Generic T1 - Future use of Micro-arrays in enforcement Y1 - 2008 A1 - Marc Van den Bulcke KW - Biology KW - dissemination KW - future KW - meeting KW - method KW - methods KW - ON KW - traceability KW - use KW - Workshop JF - Trace meeting: TRACE DISSEMINATION WORKSHOP ON "MOLECULAR BIOLOGY METHODS FOR TRACEABILITY PURPOSES" PB - NA CY - NA CP - BfR U1 - 390 U2 - 19/12/2008 ER - TY - Generic T1 - NRL course Bottlenecks in GMO analysis Y1 - 2008 A1 - Marc Van den Bulcke KW - analysi KW - analysis KW - Communication KW - de KW - GMO JF - Groupe de communication NRL PB - NA CY - NA CP - NRL U1 - 388 U2 - 30/10/2008 ER - TY - BOOK T1 - Challenges for future research in GMO detection T2 - Towards a safer food supply in Europe Y1 - 2007 A1 - Berben,G. A1 - F. Debode A1 - M. De Loose A1 - E. Janssen A1 - N. Papazova A1 - Myriam Sneyers A1 - I. Taverniers A1 - Amaya Leunda A1 - Adinda De Schrijver A1 - Marc Van den Bulcke ED - C.Van Peteghem KW - event-specific identification KW - fingerprinting KW - GMO characterization KW - Method validation KW - qualitative PCR KW - QUALITY ASSURANCE KW - Quantitative real-time PCR KW - SCREENING AB - This article reviews several research challenges for GMO detection as some pending questions still exist and need more research efforts to be solved. The question of how to apply validation in a modular scheme is handled. It is followed by the problem of how to manage the detection of an always increasing number of new events and the fact that in such a context screening will probably be more and more important. The issue of detection of unauthorized GMOs with special attention to unknown GMOs is considered. Some technical limitations in result expression with respect to botanical impurities or stacked events are also addressed. Finally the establishment of plasmid reference calibrants as alternative to the current plant-derived certified reference materials, their distribution and utilisation are discussed. JF - Towards a safer food supply in Europe PB - Belgian Science Policy CY - Brussels SN - 978-90-8756-032-4 U1 - 38512 ER - TY - JOUR T1 - Detection of genetically modified plant products by protein strip testing: An evaluation of real-life samples JF - Eur. Food Res. Technol. Y1 - 2007 A1 - Marc Van den Bulcke A1 - Adinda De Schrijver A1 - De Bernardi,D. A1 - Y. Devos A1 - G.E. Mbongolo-Mbella A1 - Amaya Leunda A1 - W. Moens A1 - Myriam Sneyers AB - The determination of the presence of genetically modified plant material by the detection of expressed genetically engineered proteins using lateral flow protein strip tests has been evaluated in different matrices. The presence of five major genetically engineered proteins (CP4-EPSPS, CryIAb, Cry9C, PAT/pat and PAT/bar protein) was detected at low levels in seeds, seed/leaf powder and leaf tissue from genetically modified soy, maize or oilseed rape. A comparison between "protein strip test" (PST) and "polymerase chain reaction" (PCR) analysis of genetically modified food/feed samples demonstrates complementarities of both techniques. -® Springer-Verlag 2007 VL - 225 CP - 1 U1 - 2797 M3 - http://dx.doi.org/ ER - TY - BOOK T1 - Regulatory/legal framework of GMO detection2801 T2 - Towards a safer food supply in Europe Y1 - 2007 A1 - Marc Van den Bulcke A1 - Myriam Sneyers ED - Carlos Van Peteghem KW - a KW - AS KW - Commercialization KW - Control KW - detection KW - detection method KW - EU KW - Europe KW - feed KW - food KW - Food Supply KW - GMO KW - GMO detection KW - GMOs KW - IS KW - labeling KW - method KW - methods KW - plant KW - production KW - PRODUCTS KW - Quantification KW - regulation KW - relative KW - SBB KW - threshold KW - traceability KW - treshold KW - website AB - In the EU, the production and commercialization of GMOs and GMO-containing or -derived food and feed products are regulated by the 'Food and Feed' Regulation (EC)No 1829/2003 and the 'Labeling and Traceability' Regulation (EC) No 1830/2003.Labelling is mandatory above a 0.9% threshold GMO percentage, relative peringredient (and translated as plant taxa for analytical purposes). Analytical methods fordetection and accurate quantification of GMO contents in derived food and feedproducts, require robust detection methods and adequate reference materials asidentifier and quantifier controls. JF - Towards a safer food supply in Europe PB - Belgian Science Policy CY - Brussels SN - 978-90-8756-032-4 U1 - 39014 ER - TY - PAT T1 - Transgenic plant event detection Y1 - 0 A1 - Marc Van den Bulcke A1 - A. Lievens A1 - Amaya Leunda A1 - G.E. Mbongolo-Mbella A1 - Piednoir,E. A1 - Myriam Sneyers KW - detection KW - Development KW - feed KW - food KW - plant KW - Plants KW - PRODUCTS KW - Transgenic CP - 29/01/2008 ER -