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.
Myriad filed the first PMA module with the FDA, though based on the agency's feedback it's unclear whether it will view myChoice HRD as a companion or complementary test.
Roche's Cobas EGFR v2 mutation test will be able to identify advanced NSCLC patients with EGFR mutations who are likely to benefit from the next-generation treatment.
The non-small cell lung cancer drug now has two FDA-approved companion tests, Abbott's FISH test and Ventana's IHC test, for identifying patients most likely to benefit from treatment.
The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.
Using gene drives to control invasive species might be too risky, an initial advocate of the approach says.
In Science this week: intellectual property experts argue patent battles such as the one over CRISPR are wasteful, and more.
Researchers have grown tumors in 3D cell cultures to better understand cancer, the Economist reports.