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7 Jan 2016

Merck and Biocartis to collaborate on new liquid biopsy technology for RAS biomarker testing

Merck becomes first pharmaceutical company to collaborate with multiple diagnostic providers to support RAS biomarker testing.

Merck 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’ 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. “Through this collaboration, our desire is to have more metastatic colorectal cancer patients gain access to liquid biopsy RAS testing, regardless of their geographical location,” said Rehan Verjee, Chief Marketing and Strategy Officer of Merck’s biopharma business. “As the first pharmaceutical company to collaborate with multiple diagnostic providers of liquid biopsy RAS testing, we are living our commitment to supporting patients and physicians by going beyond treatment. 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.

“Today, complex diagnostic laboratory infrastructure and specialized expertise requirements are important barriers when it comes to the implementation of personalized medicine on a global scale.” said Rudi Pauwels, CEO Biocartis. “We are pleased to partner with Merck, who supports us in putting personalized medicine into daily practice with this collaboration, through the development of rapid and accurate tests on the Idylla system. After having already launched solid biopsy RAS tests, the Idylla liquid biopsy RAS test is a logical next step in our rapidly expanding menu of oncology tests.”

Merck and Biocartis plan to implement the Idylla liquid biopsy RAS test in numerous medical centers across the world, excluding the US, 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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