The approval allows AmoyDx to market the KRAS test for clinical use in China and can currently be used for research purposes only in countries other than China
The assay is based on proprietary technology, Adx-ARMS, which uses a patented two-step process to detect genetic changes, or mutations, in the KRAS gene.
The KRAS test kits are assembled in AmoyDx’s GMP-certified manufacturing plant.
Global Operations executive VP David Whyte said this is significant because it is the first molecular diagnostics test to be approved in China for use in personalized clinical testing for cancer patients.
"More importantly, it is a new tool for physicians and other health care providers to help them make more informed decisions on how best to combat their patients’ cancers," Whyte said.
Amoy Diagnostics president Zheng said they are proud that the company has developed a test that can shed light on the molecular mechanisms driving growth of individuals’ tumors.
