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Future of Personalised Medicine: Quality Assurance of Oncology Biomarker Testing is Essential
Boek - Dissertatie
Future of personalised medicine: quality assurance of oncology biomarker testing is essential
Tumour specific mutations play an increasing role in the selection of targeted therapy. However testing forthese mutations is not straightforward and errors occur. This could lead to a denial of treatment to patients whowould actually benefit from it, or a superfluous use of high-priced therapeutic agents and unnecessary side
effects in patients who have no benefit of the drug. Evidence based criteria for an optimal diagnostic setting forsuch tests are lacking.This project will monitor the performance of laboratories that participate to different external qualityassessment (EQA) programs for oncology biomarker testing. Based on the outcome of this analysis, the qualityassessment of the testing process in medical laboratories will be optimised and patient safety in personalisedmedicine 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 NGSbased 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 testingresults.• To identify and create tools and to develop recommendations to increase the quality assurance for rapidintroduction of biomarker testing. This is to ensure the patient safety in the field of personalised medicineThe first part consists of a longitudinal analysis to find associations between a successful EQA participation andcharacteristics of the participating laboratories. The follow-up in time of laboratories that changed, or willchange, to a next generation sequencing (NGS) method will get special attention. This method is becoming thenew standard in molecular pathology analysis and we want to analyse whether there is a negative influence onthe laboratory's performance and how this can be avoided. The longitudinal analysis, in addition to theelaboration 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 laboratoriesthat 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 andrecommendations 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 formulatespecific guidelines. Also here, there is a focus on labs implementing NGS. With this technique, additionalinformation must be present in the report to make a well-informed therapy decision. On the other hand, thereport must remain clear and comprehensible. For now, no consensus is reached and labs report according totheir own system.The further elaboration of the findings will lead to the proposition of tools to increase quality assurance inpersonalised medicine. Incorrect therapy choices must be avoided at all times, on the one hand to increase
Tumour specific mutations play an increasing role in the selection of targeted therapy. However testing forthese mutations is not straightforward and errors occur. This could lead to a denial of treatment to patients whowould actually benefit from it, or a superfluous use of high-priced therapeutic agents and unnecessary side
effects in patients who have no benefit of the drug. Evidence based criteria for an optimal diagnostic setting forsuch tests are lacking.This project will monitor the performance of laboratories that participate to different external qualityassessment (EQA) programs for oncology biomarker testing. Based on the outcome of this analysis, the qualityassessment of the testing process in medical laboratories will be optimised and patient safety in personalisedmedicine 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 NGSbased 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 testingresults.• To identify and create tools and to develop recommendations to increase the quality assurance for rapidintroduction of biomarker testing. This is to ensure the patient safety in the field of personalised medicineThe first part consists of a longitudinal analysis to find associations between a successful EQA participation andcharacteristics of the participating laboratories. The follow-up in time of laboratories that changed, or willchange, to a next generation sequencing (NGS) method will get special attention. This method is becoming thenew standard in molecular pathology analysis and we want to analyse whether there is a negative influence onthe laboratory's performance and how this can be avoided. The longitudinal analysis, in addition to theelaboration 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 laboratoriesthat 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 andrecommendations 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 formulatespecific guidelines. Also here, there is a focus on labs implementing NGS. With this technique, additionalinformation must be present in the report to make a well-informed therapy decision. On the other hand, thereport must remain clear and comprehensible. For now, no consensus is reached and labs report according totheir own system.The further elaboration of the findings will lead to the proposition of tools to increase quality assurance inpersonalised medicine. Incorrect therapy choices must be avoided at all times, on the one hand to increase
Jaar van publicatie:2019