Merck has signed a collaboration agreement with Biocartis NV for the development and commercialization of a new liquid biopsy RAS biomarker test for patients with metastatic colorectal cancer, or mCRC. The test will be developed on Biocartis' innovative, 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.

Understanding metastatic colorectal cancer (mCRC) patients' individual biomarker status is key to support timely treatment decision-making. The Biocartis technology will be complementary to other technology previously developed, and will allow for liquid biopsy RAS offerings to a wide range of lab segments, regardless of size and expertise levels. 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. The test will be available for Research Use Only (RUO) in second half of 2016 and is shortly thereafter planned to be submitted for a CE Mark.