Experts from BIO Deutschland’s Working Group on Diagnostics Meet in Berlin

The experts from BIO Deutschland’s Working Group on Diagnostics met in Berlin in March to discuss the topic of companion diagnostics. In an introductory lecture on the subject, Christiane Chène (Dr. Regenold GmbH) presented the regulations on companion diagnostics in the USA and compared them with the situation in Europe. After the presentation, the participants discussed the current and expected regulatory parameters for diagnostic manufacturers. To date, there are no specific regulations in Europe on the tests that diagnose whether a therapy will have a successful outcome for a patient in a specific case. However, the experts from the working group expect the first regulations on companion diagnostics to be introduced as part of the revision of the Medical Devices Directive and the In Vitro Diagnostic Medical Devices Directive.

The participants also discussed the idea of showcasing the advantages of personalised medicine from the perspective of diagnostic manufacturers. There are currently many signs that using diagnostics at an early stage can have a significant impact on therapeutic success and thus lead to cost savings. The working group will gather data and facts that prove the positive influence of such tests in order to emphasise the favourable impact of innovative diagnostics on medical drug therapy and prevention. In the long term, the group plans to draft a position paper based on the data gathered.

After the meeting, the working group’s experts made use of the opportunity to obtain information on the topics of evaluation, regulation and reimbursement of innovative diagnostics at the DiagnostikNET BB innovation forum. The lectures and discussions demonstrated the difficulties in the field, particularly as regards billing for innovative tests. The system currently and specifically thwarts innovations. Improving these conditions is a priority of the group’s work.

Members of BIO Deutschland are welcome to request a copy of the minutes of the meeting from the association’s office.