2018-07-11| Trials & Approvals

CFDA processes priority review of BGI’s BRCA1/2 gene testing kit

by GeneOnline
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The BRCA1/2 gene mutation detection kit by the BGI Wuhan Ltd., a subsidiary of the Beijing Genomics Institute (BGI), received the priority reviewing notice from the Centre of Medical Device Evaluation, China Food and Drug Administration (CFDA) [1]. This BRCA1/2 gene testing kit is the first genetic test to be listed on the innovative medical device priority reviewing process.

By Joanne Shih

This BRCA1/2 gene mutation detection kit is performed with BGI’s in-house high-throughput sequencer and with combinatorial probe anchor synthesis (cPAS)-based sequencing method. This kit is designed for detecting germline variant of the exon and adjacent intron regions of BRCA1 and BRCA2 genes in patients with clinically diagnosed ovarian cancer and breast cancer.

The existence of BRCA1 and BRCA2 mutations is highly related to the efficacy of poly (ADP-ribose) polymerase (PARP) inhibitors when treating cancer. Therefore, being able to quantify the gene mutations in patients with BRCA-related cancers will allow clinicians to make more accurate treatment decision and advance the outcome of targeted therapy that uses PARP inhibitors.

If this BGI’s gene testing kit receive further approval from CFDA, it will be the first gene testing kit guiding the use of PARP inhibitors and may be beneficial to a large number of cancer patients.


  1. Centre of Medical Device Evaluation.CFDA:
  2. Okuma HS, Yonemori K. BRCA Gene Mutations and Poly(ADP-Ribose) Polymerase Inhibitors in Triple-Negative Breast Cancer. DOI. 10.1007/978-981-10-6020-5_13


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