Myriad Genetics Gets FDA Approval Of MyChoice CDx Test As Companion Diagnostic For Zejula, PARP Inhibitor From GSK, For Patients With Advanced Ovarian Cancer

Myriad Genetics, Inc. has received FDA approval for its MyChoice CDx Test as a companion diagnostic for GSK's Zejula (niraparib) in patients with advanced ovarian cancer. This approval is based on data from the PRIMA trial, where the test was used to determine homologous recombination deficiency (HRD) status. The MyChoice CDx Test is the only FDA-approved test in the U.S. for identifying HRD-positive patients eligible for Zejula treatment.