Myriad Genetics submits 1st PMA application module to FDA for test

Myriad Genetics announced that it has submitted the first module of its premarket approval, or PMA, application to the FDA for its myChoice HRD CDx test. Myriad is submitting myChoice HRD as a companion diagnostic for the identification of patients with ovarian, fallopian or primary peritoneal cancer who have received three or more lines of therapy and whose tumors harbor a BRCA mutation or are BRCA wild type yet are deficient in homologous recombination DNA repair and sensitive to their last round of platinum and could derive clinical benefit from treatment with the poly ADP ribose inhibitor Zejula.

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