PMA

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.

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.

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 agency has granted the drug and CDx priority review, which Myriad expects to conclude during its fiscal third-quarter ending March 31, 2018.

The RealTime PCR instrument identifies AML patients with IDH2 mutations who can be treated with Celgene's Idhifa.

The so-called universal CDx approved by the FDA can gauge alterations across multiple genes associated with response to three lung cancer treatments. 

The firm said the assay provides flexible automation and accurately identifies all six HCV genotypes as well as subtypes 1a and 1b.

Hologic said that HCV therapeutic options are evolving rapidly, and the approval will enable physicians to quickly decide on the best treatments.

Thermo Fisher developed the NGS-based multi-marker assay in collaboration with Novartis and Pfizer to match lung cancer patients with targeted drugs.