Quality in Molecular Oncology Testing Laboratories in Europe: a View from Different Angles

Increased knowledge about the molecular mechanisms involved in cancer pathogenesis has led to the development of novel targeted therapies for various cancer types. In order to have an effective treatment, knowledge about the mutation status of certain genes is often required. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) decided, for example, that wild-type RAS status is required prior to cetuximab or panitumumab therapy for metastatic colorectal cancer (mCRC).  The reliability and accuracy of such biomarker testing is of utmost importance for clinical decision-making and patient care, especially since the enormous increase of high-throughput sequencing methodologies. False positive and negative results might lead to the denying of treatment to a patient who would have benefited from it or the overuse of these high-priced therapeutic agents, which can even cause adverse events.

The Biomedical Quality Assurance (BQA) research group from the KU Leuven provides external quality assessment (EQA) schemes for cystic fibrosis, mCRC and non-small-cell lung cancer in collaboration with the European Society of Pathology (ESP).

The ultimate aim of this project is to improve patient safety, which will emerge from enhancing laboratory performance during EQA participation and daily practice. First, the impact of tumor cell percentage on the accuracy of biomarker testing as well as on the interpretation of the test result will be assessed. In a second part, ‘difficult test samples’ such as samples containing too few tumor cells or with poor DNA quality, will be identified. Furthermore, it will be evaluated how laboratories react on such samples and whether those ‘difficult samples’ belong to an EQA scheme. The last goal of the project is to map the network of molecular diagnostic laboratories. The focus will be on requesting the tests, reporting of the test results and the subsequent interpretation by the oncologist and the use of referral laboratories.

Results and new insights will be used for optimization of the test procedure and the organization of medical laboratories in order to improve patient safety.