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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.

One of the applications seeks premarket approval to run the Vitros immunodiagnostic HIV combo assay on the Vitros 3600 system.

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

The company has started a clinical validation study for a PSA test running on the Claros 1 platform and expects to file for a PMA later this year.

The QuantiFeron-TB Gold Plus uses immunoassay technology to detect the release of interferon-gamma as a proxy for latent tuberculosis infection.

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.

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