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Merck KGaA, Sysmex Inostics Partner on Development of CRC Biomarker Test

NEW YORK (GenomeWeb) – Merck KGaA today said that it will collaborate with Sysmex Inostics on the development of a RAS biomarker mutation test for metastatic colorectal cancer.

The partners will develop the blood-based test using Sysmex Inostics' BEAMing technology, an ultra-sensitive digital PCR approach that can detect cancer cell DNA directly from blood. Though the firms didn't specifically say so, comments from a Merck official suggest the test may be developed as a companion diagnostic for Erbitux (cetuximab), a colorectal cancer treatment marketed in the US by Bristol-Myers Squibb along with Eli Lily and its Imclone Systems unit, and outside of the US and Canada by Merck Serono.

"As a company, we have embraced the principles of personalized medicine and predictive biomarkers," Belen Garijo, president and CEO of Merck Serono, said in a statement. "This collaboration reflects our commitment to leveraging our expertise in personalized medicine and predictive biomarkers in order to enhance Erbitux's value proposition for patients, physicians, and payers."

In the US, Qiagen sells its therascreen KRAS RGQ PCR Kit as a companion diagnostic test for Erbitux. It received marketing clearance from the US Food and Drug Administration for the test two years ago.

Merck noted that roughly half of metastatic colorectal cancer patients have RAS wild-type tumors, and studies have shown that anti-epidermal growth factor receptor therapies, such as Erbitux, can improve outcomes in those patients.

Hamburg, Germany-based Sysmex Inostics said last fall that it would collaborate with Bayer Healthcare on a companion diagnostic for undisclosed anti-cancer therapies being developed by Bayer.