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Merck KGaA, AmoyDx Partner on Colorectal Cancer Test for Chinese Market

NEW YORK (GenomeWeb) – Germany-based Merck KGaA announced today that it has partnered with Amoy Diagnostics to develop and commercialize a liquid biopsy test for metastatic colorectal cancer for the Chinese market.

According to Merck, the test will be based on AmoyDx's proprietary real-time PCR technology known as ADx-SuperARMS — short for AmoyDx super amplification refractory mutation system — and will identify mutations in the RAS gene family.

The partners expect to roll out the test in Chinese medical centers in 2017, expanding to other markets including Argentina, India, Mexico, Taiwan, Hong Kong, Brazil, and Russia by 2019. The test will initially be available for research use only, and will be submitted for CE marking later this year by Xiamen, China-based AmoyDx. Additionally, the companies anticipate conducting a concordance study to verify the test's accuracy compared with existing tissue-based methodologies.

Additional terms of the arrangement were not disclosed.

"It is now well-accepted within the oncology community that understanding the individual RAS biomarker status of metastatic colorectal cancer patients is key to supporting timely treatment decision making," Rehan Verjee, chief marketing and strategy officer for Merck's biopharma business, said in a statement. "China is a key market for us, and our collaboration with AmoyDx will support our goal of improving care for patients with metastatic colorectal cancer by providing access to state-of-the-art, reliable, and accurate testing technology."

Merck recently completed a Phase III study in nearly 400 Chinese patients with RAS wild-type colorectal cancer demonstrating that a combination of its antibody-based cancer drug Erbitux and the chemotherapy regimen FOLFOX could improve clinical outcomes compared with FOLFOX alone.

The drugmaker has also partnered with a number of other companies on RAS biomarker assays, including Sysmex Inostics and Biocartis.