Amoy Diagnostics obtained CE Mark approval for its EGFR, KRAS, and BRAF mutation detection kits. All three assays were previously sanctioned in China.
The AmoyDx EGFR assay tests for somatic gain-of-function mutations in the tyrosine kinase domain. These variations are associated with sensitivity to small molecule kinase inhibitors such as Iressa. The drug, made by AstraZeneca, is a first-line treatment for EGFR mutation-positive advanced non-small-cell lung cancer.
AmoyDx is a supplier of EGFR mutation detection kits for AstraZeneca in China. The companies are working together to train oncologists, thoracic surgeons, pathologists, and other hospital staff in China.
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.
The AmoyDx KRAS test reportedly detects the seven most common activating mutations of the KRAS gene in cancer tissue. KRAS mutations occur in colorectal and lung adenocarcinomas as well as cancers derived from other tissues.
AmoyDx’ molecular tests are based on technology called ADx-ARMS developed at its laboratory in Xiamen, China. ADx-ARMS uses a two-step process to detect mutations in tumor DNA. AmoyDx says that the method has been validated on PCR instruments from several manufacturers including: Roche Light Cycler 480 I and Light Cycler 480 II, Stratagene MX 3000P and 3005P, and Applied Biosystems StepOnePlus, 7300, and 7500. All of the RT-PCR assays are currently being validated on the ABI 7900 instrument.
AmoyDx offerings include kits for mutation status of JAK2, ABL, PIK3CA, KIT, PDGFRA, and P53 genes. The tests include gene-expression assays to predict chemotherapy response: ERCC1 for platinum-based chemotherapy, TYMS for 5-FU based chemotherapy, and RRM1 for gemcitabine. The company also offers RT-PCR tests for chlamydia and Uu infections. Custom assays can also be designed, manufactured, and packaged in a wholly owned GMP-compliant ISO13485-certified facility.