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Amoy Diagnostics Gets China OK for Cancer MDx Tests

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Amoy Diagnostics this week received marketing approval from China's State Food and Drug Administration for its EGFR and BRAF tests for clinical use.

The AmoyDx EGFR assay tests for mutations in the tyrosine kinase domain associated with sensitivity to the kinase inhibitors gefitinib (Iressa) and erlotinib (Tarceva). According to the Ziamen, China-based firm, the test also detects the T790M mutation that is associated with resistance to treatment.

The AmoyDx BRAF test detects the mutation that causes the V600E amino acid substitution in the BRAF protein, which is found primarily in malignant melanoma. The firm noted that several drug firms are developing therapies targeting the BRAF mutation.

David Whyte, VP of global development for Amoy, noted in a statement that the firm has partnered with AstraZeneca, which sells Iressa, to introduce the EGFR kits to clinicians in mainland China.

Amoy said that the assays can run on Roche's LightCycler 480 I and LightCycler 480 II; Stratagene's MX 3000P and 3005P; Applied Biosystems' StepOnePlus, 7300, 7500, and 7900; and Bio-Rad's IQ5 and CFX96.

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