NEW YORK (GenomeWeb News) – Chinese molecular diagnostics firm Amoy Diagnostics today announced the Chinese State Food and Drug Administration has approved its KRAS mutation detection kit.
The Xiamen-based firm can now market its KRAS test for clinical use in China. In a statement, AmoyDx said the KRAS kit is the first molecular diagnostic assay to receive approval in China for use in personalized clinical testing in oncology.
The test "is a new tool for physicians and other healthcare providers to help them make more informed decisions on how best to combat their patients' cancers," David Whyte, executive vice president of global operations for AmoyDx, said in a statement.
The assay is based on the company's ADx-ARMS technology, which uses a two-step process to detect mutations in the KRAS gene. The method has been validated on several PCR platforms including the Roche Light Cycler 480 I and Light Cycler 480 II; Stratagene MX 3000P and 3005P; Applied Biosystems StepOne Plus 7300 and 7500; and Bio-Rad IQ5 and CFX96.
AmoyDx has also developed and validated test kits for EGFR and BRAF mutations based on the ADx-ARMS technology. It said that it anticipates SFDA approvals for the tests soon. It has applied for the CE Mark for its KRAS, EGFR, and BRAF assays.