Amoy Diagnostics announced today that its EGFR and BRAF mutation detection kits received market approval from China’s State Food and Drug Administration (SFDA). The SFDA is the competent authority for regulating drugs and in vitro diagnostics in mainland China. The approval allows AmoyDx to market the EGFR and BRAF tests for clinical use in China.
The assays are based on proprietary technology developed in AmoyDx’s laboratory in Xiamen, China. The technology, called “ADx-ARMS”, uses a patented two-step process to detect mutations in the EGFR and BRAF genes. The method has excellent sensitivity and accuracy, and has been validated on PCR instruments from several manufacturers. The test kits are assembled in AmoyDx’s ISO13485-certified, GMP-compliant manufacturing plant.
The AmoyDx EGFR assay tests for somatic gain-of-function mutations in the tyrosine kinase domain that are associated with sensitivity to the small-molecule kinase inhibitors gefitinib or erlotinib. It also detects the T790M mutation that is associated with resistance to treatment. EGFR mutations are found in cancers of the lung, colon, cervix and esophagus.
The AmoyDx BRAF test detects the mutation that causes the V600E amino acid substitution in the BRAF protein. The BRAF V600E mutation is found predominantly in malignant melanoma, sporadic colorectal tumors showing mismatch repair defects in microsatellites, low-grade ovarian serous carcinoma and thyroid papillary cancer. Therapeutic agents targeting activated BRAF are in development in a number of companies.
“Amoy Diagnostics is well positioned to provide companion diagnostic tests for therapeutic agents targeting the EGFR pathway” said David Whyte, PhD, vice president of global development at Amoy Diagnostics. “The EGFR kit provides the most comprehensive coverage of mutations available in an SFDA-approved assay. We have partnered with AstraZeneca to introduce our EGFR kits to clinicians in mainland China through a series of workshops, and we are now focused on expanding our market to include clinical labs, pharmaceutical companies and research institutions outside of China”.
AmoyDx also recently received SFDA approval for its KRAS mutation detection kit. The company has applied in Europe for CE marks for the EGFR, KRAS and BRAF tests.
AmoyDx has developed procedures for EGFR and BRAF testing using the following machines: Roche Light Cycler 480 I & Light Cycler 480 II; Stratagene MX 3000P & 3005P; Applied Biosystems StepOnePlus, 7300, 7500 & 7900; Bio-Rad IQ5 & CFX96.
AmoyDx has a rich pipeline of molecular tests that are being developed in its ISO 13485-certified laboratory. The portfolio of tests focuses on cancer-related somatic mutations (EGFR, KRAS, BRAF, KIT, PIK3CA, JAK2, ABL1, PDGFR1, TP53) chemotherapy response (gene expression levels for ERCC1, RRM1, TYMS transcripts), and infectious disease agents (Ureaplasma urealytica, Chlamidia trachomatis and Hepatitis B virus quantitative assay). Custom assays can also be designed, manufactured and packaged in a wholly-owned GMP-compliant facility. Please see the website at http://www.amoydx.com/en for more details.