By using AmoyDx real-time polymerase chain reaction (PCR) technology, the companies will develop the new test, which is expected to be launched in China in 2017.
The AmoyDx-super-amplification-refractory mutation system (ADx-SuperARMS) will be used to carry out specific gene-mutation analysis.
The ADx-SuperARMS detects mutations in blood samples, which contain a as little as 0.2% mutant DNA in a background of wild-type genomic DNA.
Expected to provide results within 120 minutes, the liquid biopsy RAS biomarker test has been validated on several PCR platforms that are commonly used in diagnostic laboratories.
The companies intend to implement the ADx-SuperARMS liquid biopsy RAS test in Chinese medical centers in the next year, and plan to introduce in other markets such as Argentina, India, Mexico, Taiwan, Hong Kong, Brazil, and Russia by 2019.
AmoyDx is planning to submit the new test for CE mark approval in this year, making it initially available for research use only (RUO).
Merck biopharma business chief marketing and strategy officer Rehan Verjee said: “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.”
AmoyDx CEO Dr. Li-Mou Zheng said: “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.”
Image: Merck and AmoyDx to develop and commercialize new liquid biopsy RAS biomarker test. Photo: courtesy of AMOY DIAGNOSTICS CO., LTD.
