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NEW YORK (GenomeWeb) – Myriad Genetics said it has submitted the first module of its premarket approval application for myChoice HRD CDx with the US Food and Drug Administration.

The firm is seeking approval of myChoice HRD as a test that can identify patients with ovarian, fallopian, or peritoneal cancer whose tumors are deficient in homologous recombination DNA repair, regardless of their BRCA mutation status, and may benefit from treatment with GlaxoSmithKline's niraparib (Zejula) as a fourth-line option.

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