FDA approves first second-generation gene sequencing diagnostic kit

On December 19, 2016, the US Food and Drug Administration (FDA) approved Foundation Medicine's FoundationFocus CDxBRCA product, becoming the first companion diagnostic kit based on second-generation sequencing on the market.

The product is approved for the identification of patients with advanced ovarian cancer who carry the BRCA mutation, and these patients are more likely to respond to the PARP inhibitor Rubraca (rucaparib) produced by Clovis Oncology. At the same time, the FDA has accelerated the approval of the new Rubara drug, which is indicated for patients with advanced ovarian cancer who have been treated with two or more chemotherapies and carry harmful BRCA1 and BRCA2 gene mutations. FoundationFocus CDxBRCA is a companion diagnostic kit for the detection of BRCA1 and BRCA2 mutations using formalin-fixed paraffin-embedded (FFPE) ovarian tumor tissue using NGS technology. The results of this test can be used to identify ovarian cancer patients who are considering treatment with Rubraca. If the patient has a positive result for a BRCA1/2 deleterious mutation, it may be appropriate to receive Rubraca treatment.

According to the latest statistics from the National Cancer Institute, more than 22,000 women will be diagnosed with ovarian cancer, and more than 14,000 women will die from the disease. Among them, 15% to 20% of ovarian cancer patients carry BRCA mutations. FoundationFocus CDxBRCA can be used to detect such mutations in a patient's tumor tissue.

Previously, in December 2014, the FDA approved AstraZeneca's PARP inhibitor Lynparza (olaparib) and Myriad Genetics' companion diagnostic product, BRACAnalysis CDx, for the identification of patients with advanced ovarian cancer who received more than three lines of chemotherapy and had a BRCA mutation. Myriad's companion diagnosis can detect germline mutations based on patient blood, where PCR and Sanger sequencing are used to analyze single nucleotide mutations and Indel, and multiplex PCR is used to assess large fragment deletions and duplications.

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