On 27th and 28th April 2022, the 12th Clinical Biomarker & CDx Summit Europe took place where the latest trends in CDx were discussed.
Experts highlighted that there are still some uncertainties regarding the details and the impact of the upcoming EU-IVDR on the industry
Janssen & Illumina announced a strategic partnership, showing the importance of pharma and diagnostics companies working closely together to advance CDx
Norbert Farkas, Founder & Managing Partner of CENTIVIS AG, facilitated a roundtable discussion to address the main reimbursement challenges raised by industry experts
On 27th & 28th April 2022, various experts from research, pharma, and diagnostics came together at the 12th Clinical Biomarker & CDx Summit Europe to discuss the latest trends in CDx and to explore synergies.
EU-IVDR’s implications are not yet fully transparent
One of the main discussion points among industry experts was the upcoming EU-IVDR, highlighted by a talk by TÜV Süd. While it became clear that the EU-IVDR will require the industry to invest more into clinical trials and evidence generation, stronger regulatory oversight is generally seen as positive for further ensuring patient safety and improving outcomes. Even though not all the details and implications of the EU-IVDR are fully transparent yet, the industry is confident that it can adapt to the new requirements and find appropriate solutions.
Strategic partnerships are key to advancing CDx
Furthermore, the discussions between the industry experts showed that formerly complex and expensive technologies have become more affordable. Thanks to relentless research and product development, they have found their way into routine clinical testing. Pharma companies, for example, rely more than ever on technologies such as NGS to stratify their patients for therapy selection. The need for high-quality testing was underlined by the strategic partnership announced by Illumina and Janssen. The partnership focuses on enabling personalized, highly effective therapies across tumor types, early detection, monitoring, and effective & efficient drug discovery processes.
Advancing Diagnostics Access – Diagnostics Reimbursement Challenges & Potential Solutions in Europe
CDx reimbursement has become more and more important to enable appropriate patient and therapy selection.
During an interactive session, Norbert Farkas, Founder & Managing Partner at CENTIVIS AG, presented the principles of diagnostics funding in Europe and facilitated a roundtable discussion to address the main reimbursement challenges raised by the audience, consisting of leading market access experts.
The top 3 challenges brought up and discussed by the audience:
Missing guidance regarding the exact evidence requirements by authorities
NGS acceptance in other oncology indications other than NSCLC
Limited public funding
Potential solutions discussed:
Authorities should hold advisory boards, ideally on the EU level, to provide specific guidance on evidence requirements in addition to clear publications of recommendations
The industry needs to pool interests to collect and develop evidence to justify tumor agnostic NGS/CGP usage and path the way for access
Pharmaceutical and diagnostic companies need to demonstrate the high unmet clinical need to raise awareness among decision-makers and get them to create appropriate reimbursement opportunities.
Overall, the conference was a valuable opportunity to meet various experts within the field of CDx, exchange ideas, and lay the foundation for the future of CDx. Once again, we would like to thank the organizers Hanson Wade for the opportunity to present a market access overview and we look forward to future conferences.