Myriad Seeks FDA Approval of myChoice HRD CDx Diagnostic Test for Ovarian Cancer Patients

Myriad Seeks FDA Approval of myChoice HRD CDx Diagnostic Test for Ovarian Cancer Patients
Myriad Genetics has submitted the first part of a premarket approval application with the U.S. Food and Drug Administration for myChoice HRD CDx, a diagnostic test designed to identify ovarian cancer patients more likely to benefit from treatment with the PARP inhibitor Zejula (niraparib). Premarket approval is the FDA's scientific and regulatory review to evaluate the safety and effectiveness of medical devices that support or sustain human life, are of substantial importance in preventing human health issues, or which present a potential, unreasonable risk of illness or injury. myChoice HRD CDx identifies cancers with defects in homologous recombination, a pathway key for DNA repair.  Tumors that lose their ability to
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