PMA

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.

NEW YORK (GenomeWeb News) ─ Myriad Genetics has submitted to the US Food and Drug Administration the first module of its premarket approval application for BRACAnalysis as a companion test for AstraZeneca's breast cancer PARP inhibitor olaparib.

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The Jackson Laboratory has filed a complaint accusing Nanjing University of breeding and re-selling its mouse models, the Hartford Courant reports.

Oxford researchers are turning to virtual reality to visualize genes and regulatory elements, Phys.org says.

In Science this week: neutrophils rely on microRNA to protect against lung inflammation, and more.

China is moving forward with plans to sequence a million citizens, the Wall Street Journal reports.