PMA

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.

NEW YORK (GenomeWeb News) – Exact Sciences said after the close of the market Tuesday that the US Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the firm's premarket approval application for its Col

NEW YORK (GenomeWeb News) – Roche today said that it has submitted a Premarket Approval supplement to the US Food and Drug Administration seeking the addition of a cervical cancer primary screening indication for its cobas HPV Test.

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A fire at a Manchester hospital may have destroyed lab equipment and data, the Guardian reports.

Researchers generate a genetic database from skeletal remains from the 1845 Franklin Expedition to the Arctic, Live Science reports.

Researchers in China have begun another trial using CRISPR/Cas9 approaches in cancer patients, according to the Wall Street Journal.

In Science this week: human DNA found in sediments from archeological sites lacking bones, and more.