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The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.
The test is approved to gauge germline BRCA mutations in advanced breast cancer patients who may benefit from treatment with Pfizer's PARP inhibitor Talzenna.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
Among companies whose tests were greenlighted by the FDA last month, Quidel received clearances for a test to detect and differentiate influenza types A and B, and for a separate test for Lyme disease.
Alere received FDA 510(k) clearances for four tests, including those for influenza A and B, strep A, and RNA-based respiratory syncytial virus.
The firm noted that the premarket approval means that the three major viral load assays that most laboratories run for patients are now available on a single system.
The firm has completed a US clinical trial for a test that detects antibodies to HIV types 1 and 2 and Treponema pallidum, the causative agent for syphilis.
The agency has granted the drug and CDx priority review, which Myriad expects to conclude during its fiscal third-quarter ending March 31, 2018.