FDA approves liquid biopsy test for somatic, germline mutations
medwireNews: The US FDA has granted approval for a next-generation sequencing (NGS) diagnostic blood test that can identify alterations in genes associated with cancer and targeted therapies.
The FoundationOne Liquid CDx (Foundation Medicine Inc, Cambridge, Massachusetts, USA) has been approved as a companion diagnostic test for identification of EGFR exon 19 deletions and exon 21 L858R alterations for use of gefitinib, osimertinib, and erlotinib in patients with non-small-cell lung cancer.
The test is also able to identify alterations in BRCA1 or BRCA2 in metastatic castration-resistant prostate cancer patients who may be suitable for rucaparib treatment.
Patients who test negative with the liquid biopsy should be directed to routine biopsy and an approved tumour tissue test, the FDA advises.
Commenting on the announcement in a press release, Mark Socinski (AdventHealth Cancer Institute, Orlando, Florida, USA) said the approval “helps expand access to important genomic information needed for physicians to make more informed decisions about targeted approaches for their parents and is another important step toward making comprehensive genomic testing a part of routine clinical cancer care.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of the Springer Nature Group