Merck has entered into an agreement with Amoy Diagnostics (AmoyDx) to develop and commercialise the new ADx-SuperARMS liquid biopsy RAS test for metastatic colorectal cancer (mCRC).
The test will be developed based on AmoyDx real-time polymerase chain reaction (PCR) technology, AmoyDx-Super-Amplification-Refractory Mutation System (ADx-SuperARMS).
ADx-SuperARMS has been approved by the Consensus Group for KRAS Gene Mutation Detection in Colorectal Carcinoma, part of the China Pathology Quality Control Centre.
It is a mutation detection technology which identifies mutations in blood samples containing a low 0.2% mutant DNA in the presence of wild-type genomic DNA.
The liquid biopsy test is easy to use and is expected to provide clinical practices with accurate molecular diagnostic screening.
It features cards pre-loaded with polymerase chain reaction (PCR) which facilitates a faster and sensitive mode of operation.
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.
“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.”
Merck and AmoyDx are planning to introduce the ADx-SuperARMS liquid biopsy RAS test in Chinese medical centres next year.
The test will initially be available for research use only (RUO) while AmoyDx apply for the CE Mark Approval of the test this year.