Amoy Diagnostics has received market approval from China's State Food and Drug Administration (SFDA) for its KRAS mutation detection kit. The assay is based on technology developed in AmoyDx’ laboratory.
The technology, called ADx-ARMS, uses a two-step process to detect genetic mutations in the KRAS gene. The method has outstanding sensitivity and accuracy and has been validated on PCR instruments from several manufacturers, according to the company. The KRAS test kits are assembled in AmoyDx’ GMP-certified manufacturing plant.
AmoyDx has developed procedures for KRAS testing using the following machines: Roche Light Cycler 480 I and Light Cycler 480 II; Stratagene MX 3000P and 3005P; Applied Biosystems StepOnePlus, 7300, and 7500; and Bio-Rad's IQ5 and CFX96.
AmoyDx has also developed and validated test kits for EGFR and BRAF mutations based on the ADx ARMS technology. SFDA approvals for these tests are anticipated soon, the firm notes. The company also applied in Europe for CE marks for the KRAS, EGFR, and BRAF tests.