In short
Sciensano is researching the feasibility of using NGS in routine clinical diagnosis in the field of oncology and hemato-oncology in Belgium. Next Generation Sequencing (NGS) is a complex and innovative technique that makes it possible to detect the variants in a cancer accurately and quickly, with one single test, by analyzing the entire genome or the relevant regions of the genome. We use a step-by-step process, within the context of a Belgian Health Care Knowledge Center (KCE) study.
Project description
A tumor develops due to changes (mutations) that occur in the DNA of a normal cell. Molecular tests detect these changes in the DNA, which means these tests are of major importance for cancer diagnosis and prognosis. They also play a substantial role in selecting those patients who may derive the greatest benefit from a treatment that specifically targets the change that has occurred (targeted therapy). This is known as personalized medicine. The implementation of complex and new technologies in the clinical routine is a major challenge in several countries, however, and demands that attention is paid to a number of key aspects, such as high quality standards, harmonized interpretation, collaboration within and between networks, as well as the ethical and legal aspects.
A step-by-step process was applied in Belgium in which the feasibility of using NGS in routine clinical diagnosis in oncology and hemato-oncology was first assessed in a KCE study, in cooperation with the Cancer Center (Sciensano).
The conclusions of this assessment were discussed and approved by the key stakeholders in Belgium (e.g. representatives of public organizations active in healthcare, patient associations and health insurers) in 2015.
The Cancer Center then outlined the conclusions derived from the feasibility study in a roadbook entitled “Introduction of Next-Generation Sequencing in routine diagnostics in oncology and hemato-oncology in Belgium”.
The roadbook, which was officially approved by the Ministry of Social Affairs and Public Health in 2015, sets out the actions required in order to introduce NGS into clinical practice (see results).
Results
Measures taken from the Belgian roadbook for the implementation of next-generation sequencing in clinical practice in oncology and hemato-oncology include:
Action 1: Establish a commission: Personalized Medicine Commission (ComPerMed)
- The “Personalized Medicine Commission ” (ComPerMed,) was established at the end of 2016. The Cancer Center serves as the scientific secretariat and coordinator of this commission.
Action 2: Development of guidelines for NGS
Action 3: Development of criteria for NGS
- The ComPerMed compiles Belgian scientific expertise on molecular detection in oncology and hemato-oncology, with its primary purpose being to determine the clinical usefulness of genetic variants. ComPerfMed’s projects have led to technical guidelines that set out the quality criteria for using NGS in the clinical routine in oncology and hemato-oncology on the one hand, as well as clinical guidelines concerning the genes or specific regions to be analyzed with NGS in relevant cancers and hematological malignancies on the other hand.
Action 4&5: Develop and organize benchmarking trials and external quality assessments for NGS
- In collaboration with Sciensano’s Quality Department, we are conducting studies for solid tumors and hematological malignancies that assess the quality of the NGS tests in Belgian laboratories for the detection of genetic anomalies in tumor samples.
Action 6: Implement NGS registration, storage and data management
- In collaboration with Healthdata.be, we have developed a technical platform for the central collection and storage of NGS data.
Action 7: NGS education and training
- NGS is a new development, with education and training therefore required. The molecular pathology working group took the initiative initially by offering pathologists a two-day course. Attending this course is compulsory for all pathology residents.
Action 8: Informed consent, legal and ethical implications for the use of NGS in molecular diagnostics
The use of NGS technology in clinical practice is associated with new legal and ethical aspects. Patients and citizens are involved in ethical debates on the use of genomic information in healthcare.
Informed Consent
The use of NGS- technology in clinical practice gives rise to new legal and ethical issues. Understanding where patients stand on NGS technology, what they find important and what they do or do not want to know, is essential for making an informed decision. We involved patients and citizens in ethical debates on the use of genomic information in healthcare. (NGS project).
55 patients came together in 11 focus groups to share their experiences and information needs concerning NGS applications in oncology.
To simplify informed consent, Sciensano has compiled a series of recommendations in the form of guidelines. To obtain balanced guidelines, the Cancer Center (Sciensano) will look at the analysis of the data from the focus groups, as well as international guidelines and legal and ethical arguments.
In accordance with these focus groups and to inform the general public about NGS technology, the cancer center produced an information video, which can currently be found on YouTube.
Action 9: Pilot Study ‘NGS in routine diagnostics’
- The aim of the pilot study is to introduce NGS technology into our public health system, and this is being achieved through an agreement (convention) between private and public laboratories and hospitals and the NIHDI (Belgian National Institute for Health and Disability Insurance) to reimburse NGS tests in oncology and hemato-oncology.
Action 10: Expand networks for NGS
- The reimbursement of the NGS test is linked to the ComPerMed-guidelines, to centralized registration of the NGS data, as well as to the hospitals’ and laboratories’ obligation to form NGS networks. The networks’ goal is to promote quality and the exchange of expertise, as well as optimize turnaround time and cost efficiency. The criteria that are taken into consideration when forming NGS networks are: the number of hospitals, the number of NGS analyses for cancer patients based on the number of multidisciplinary oncology consultants (MOC), and the presence of a competent permanent team.
