European approval for Oncobit’s cancer marker tests

University of Zurich spinoff Oncobit AG is developing cancer monitoring tests to improve personalized cancer treatment. It has received certification under the In Vitro Diagnostics Regulation (IVDR) for its Oncobit PM melanoma test suite, paving the way to CE-mark the test and offer it for clinical use. 

Oncobit's proprietary melanoma marker test Oncobit PM is designed to detect specific cancer markers in the tumor-derived fraction of circulating cell-free DNA (ctDNA) isolated from the blood of melanoma patients. The tests detect specific cancer hotspot mutations in the BRAF, NRAS, GNAQ, GNA11 and SF3B1 genes, which are critical for cutaneous and uveal melanoma. Oncobit PM is minimally invasive, cost-effective, has a fast turnaround time and is designed for personalized monitoring of disease progression and response to treatment in melanoma patients. 

The startup has now received certification under the In Vitro Diagnostics Regulation (IVDR) which confirms that Oncobit PM meets the stringent European regulatory requirements for safety, quality and performance. It underscores the company's commitment to providing reliable and state-of-the-art cancer monitoring solutions and is critical for market entry not only in Europe but also in Australia.  

"Achieving IVDR certification is a significant milestone for Oncobit, especially as IVDR certification can be challenging, and we are thrilled to offer the first IVDR-certified ctDNA monitoring solution for these melanoma markers," said Dr. Claudia Scheckel, CEO of Oncobit. "This certification not only validates the robustness and reliability of our tests, but also underscores our commitment to improving personalized cancer care. We are committed to providing healthcare professionals with the precise tools they need to make informed decisions and improve patient outcomes." 

The startup has two different customer segments for Oncobit PM. On the one hand, hHospitals use Oncobit PM reagents to perform the test on-site and use our cloud-based software for automated and unbiased analysis. The tests are already established in hospitals in Germany and Switzerland and are used for clinical trials, but also for patient monitoring in Switzerland. The team also offers the Oncobit PM test as a service for pharmaceutical companies or cancer centers and cooperates with locations in Europe and the USA. In addition to the high performance of the tests, the advantage for Oncobit's customers and partners is that they can use the fully validated and certified tests in their studies that are also available and certified for routine clinical use. “This facilitates the transfer of results to the clinical setting”, elaborated Björn Biedermann, Oncobit's Chief Business Officer.

This news comes just weeks after Oncobit signed a service agreement with UK biotech company Immunocore to improve the analysis of treatment response in clinical trials.  

(Press release / SR)