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AmoyDx Wins Chinese Regulatory Approval for BRCA Mutation Test

NEW YORK (GenomeWeb) – Amoy Diagnostics said today that the Chinese National Medical Products Administration (NMPA) has approved its BRCA1 and BRCA2 gene mutation detection kit.

The next-generation sequencing-based kit is designed for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including ovarian cancer and breast cancer, and is the first BRCA gene mutation detection product approved in China, AmoyDx said.

The Xiamen, China-based company added that the kit can also be used as a companion diagnostic for AstraZeneca and Merck's PARP inhibitor Lynparza (olaparib), which is indicated for use in cancer patients with BRCA1 or BRCA2 mutations.

In November, the NMPA approved AmoyDx's Essential NGS panel for the detection of gene mutations in non-small cell lung cancer and colorectal cancer patients. The company also received Chinese approval for its SuperARMS EGFR mutation analysis test as a companion diagnostic for EGFR TKI-based non-small cell lung cancer drugs last year.