Myriad Genetics PMA Module for Companion Diagnostic

Myriad Genetics has submitted the first module of a planned PMA for the myChoice HRD CDx test, a companion diagnostic for identifying 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 Tesaro’s poly ADP ribose inhibitor Zejula (niraparib). The submission is based on clinical data that showed the myChoice HRD test “effectively identified heavily pre-treated patients with ovarian, fallopian or primary peritoneal cancer who are likely to benefit from Zejula,” the company says. Myriad describes the test as a composite of three proprietary technologies (loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions).