Merck, a leading science and technology company, has signed a new collaboration agreement with Xiamen based Amoy Diagnostics Co., Ltd. (AmoyDx) 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 using AmoyDx real-time polymerase chain reaction (PCR) technology, ADx-SuperARMS, and will be made available in China in 2017.

The ADx-SuperARMS (AmoyDx-Super-Amplification-Refractory Mutation System) technology is designed to support clinical practice in performing specific gene-mutation analysis; the liquid biopsy RAS biomarker test is easy to perform, provides results within 120 minutes, and has been validated on several PCR platforms that are commonly used in diagnostic laboratories, when assessing for KRAS, NRAS and BRAF along with other mutations and gene signatures.

"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, and results of the recent TAILOR study in China further support the efficacy of targeted therapies such as cetuximab in RAS wild-type patients," said Rehan Verjee, chief marketing and strategy officer of Merck's biopharma business. "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 to enable a higher standard of care in China."

ADx-SuperARMS is an innovative mutation detection technology developed by AmoyDx, and is one of the key technologies recommended by the Consensus Group for KRAS Gene Mutation Detection in Colorectal Carcinoma (part of the China Pathology Quality Control Center). ADx-SuperARMS detects mutations in blood samples that contain as little as 0.2% mutant DNA in a background of wild-type genomic DNA. The ADx-SuperARMS test is designed to offer highly accurate molecular diagnostic screening for clinical practices; cards pre-loaded with PCR reagents mean a faster, more sensitive and easier to operate protocol than traditional gene sequencing approaches. The test requires a single patient blood sample to perform a RAS mutation analysis and can provide results in 120 minutes, which will enable clinicians to make treatment decisions in a timely manner.

"At AmoyDx, we pride ourselves on providing highly reliable and effective diagnostic solutions to clinical practices, which will help inform clinical decision-making and make a difference to patients with metastatic colorectal cancer," said Dr Li-Mou Zheng, CEO of AmoyDx. "As our understanding of personalized medicine evolves, we are excited that we are able to collaborate with Merck, to offer an extension to our ADx-SuperARMS testing technology capabilities that will see RAS biomarker testing available in Asia and more markets around the world."

Merck and AmoyDx plan to implement the ADx-SuperARMS liquid biopsy RAS test in Chinese medical centers in 2017, with a plan to expand into other markets such as Argentina, India, Mexico, Taiwan, Hong Kong, Brazil, and Russia by 2019. The test will be available initially for Research Use Only (RUO) and AmoyDx will submit the assay for CE Mark Approval in 2016. A concordance study will also be undertaken to verify the accuracy of the test, compared with existing tissue-based methodologies.

Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors. Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux (cetuximab), can improve outcomes in patients with RAS wild-type mCRC. Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually. An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer. Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.

Amoy Diagnostics Co., Ltd. (AmoyDx) is the pioneer in leading the technology development and industrialization of molecular diagnostics of Chinese oncology precision medicine.