Date: 2016-01-07
Type of information: Development agreement
Compound: liquid biopsy RAS biomarker test
Company: Merck KGaA (Germany) Biocartis (Belgium)
Therapeutic area: Cancer - Oncology - Diagnostic
Type agreement: development commercialisation
Action mechanism:
Disease: metastatic colorectal cancer
Details: * On January 7, 2016, Merck KGaA announced that it has signed a collaboration agreement with Biocartis for the development and commercialization of a new liquid biopsy RAS biomarker test for patients with metastatic colorectal cancer (mCRC). The test will be developed on Biocartis’ fully automated molecular diagnostics system, Idylla™, which is designed to offer accurate and reliable molecular information from virtually any biological sample in virtually any setting. The new test aims to support clinical practice in performing integrated liquid biopsy RAS biomarker tests, independently of the laboratories’ volume of testing or level of expertise.
The Idylla™ system is a fully automated sample-to-result PCR-based (polymerase chain reaction) molecular diagnostics system. It is designed to offer real-time, reliable and sensitive molecular diagnostic tests. Whereas most of today’s solutions only look for the most prevalent RAS mutations, the Idylla™ RAS test, comprising two Idylla™ cartridges, will be designed to detect an extended panel of RAS mutations. In addition, the new test will also provide a BRAF V600 mutation analysis directly integrated with the Idylla™ RAS test, to allow clinicians to evaluate BRAF and RAS mutation status simultaneously. Based on a direct sample of only 2 ml of blood plasma, the test aims to provide high sensitivity and ease-of-use. The test will be designed to require less than 2 minutes of hands-on time and a turnaround time of approximately 2 hours, enabling clinical decision-making in a timely manner.
Merck KGaA and Biocartis plan to implement the Idylla™ liquid biopsy RAS test in numerous medical centers across the world, excluding the U.S., China and Japan. The test will be available for Research Use Only (RUO) in H2 2016 and is shortly thereafter planned to be submitted for a CE Mark. A concordance study is currently also being undertaken to substantiate the value of the test.
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