Future of Personalised Medicine: Quality Assurance of Oncology Biomarker Testing is Essential

Future of personalised medicine: quality assurance of oncology biomarker testing is essentialTumour specific mutations play an increasing role in the selection of targeted therapy. However testing for
these mutations is not straightforward and errors occur. This could lead to a denial of treatment to patients who
would actually benefit from it, or a superfluous use of high-priced therapeutic agents and unnecessary sideeffects in patients who have no benefit of the drug. Evidence based criteria for an optimal diagnostic setting for
such tests are lacking.
This project will monitor the performance of laboratories that participate to different external quality
assessment (EQA) programs for oncology biomarker testing. Based on the outcome of this analysis, the quality
assessment of the testing process in medical laboratories will be optimised and patient safety in personalised
medicine will be better guaranteed.
The project is divided in four parts:
• To identify indicators related to a higher quality assurance of diagnostic biomarker testing.
• To define critical parameters for the choice, introduction, validation and implementation of different NGS
based approaches, to further improve the introduction of NGS in the Belgium laboratories.
• To optimise the communication of the test result by improving the diagnostic report for biomarker testing
results.
• To identify and create tools and to develop recommendations to increase the quality assurance for rapid
introduction of biomarker testing. This is to ensure the patient safety in the field of personalised medicine
The first part consists of a longitudinal analysis to find associations between a successful EQA participation and
characteristics of the participating laboratories. The follow-up in time of laboratories that changed, or will
change, to a next generation sequencing (NGS) method will get special attention. This method is becoming the
new standard in molecular pathology analysis and we want to analyse whether there is a negative influence on
the laboratory’s performance and how this can be avoided. The longitudinal analysis, in addition to the
elaboration on NGS data was not yet done before and shows the innovative aspect of this project.
Goal 2 aims to give a clear overview of the possibilities and drawbacks of NGS, as a guide for laboratories
that want to make an informed step towards implementation of NGS.
Thirdly, the post-analytical phase of the testing process is tackled. The currently existing guidelines and
recommendations with regard to the writing of a report in medical laboratories do not meet the expectations.
Goal 3 aims to gather information about the view and thoughts from every party involved in order to formulate
specific guidelines. Also here, there is a focus on labs implementing NGS. With this technique, additional
information must be present in the report to make a well-informed therapy decision. On the other hand, the
report must remain clear and comprehensible. For now, no consensus is reached and labs report according to
their own system.
The further elaboration of the findings will lead to the proposition of tools to increase quality assurance in
personalised medicine. Incorrect therapy choices must be avoided at all times, on the one hand to increase