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 activate this pathway as part of the cell’s response to DNA damage are unable to correctly repair cuts in the DNA, termed double-stranded breaks. This makes those cancers more susceptible to DNA-damaging anticancer treatments such as platinum-based chemotherapies (e.g., cisplatin) or PARP inhibitors, including Tesaro’s Zejula. Zejula is used as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. The myChoice test is intended as a companion diagnostic for platinum-sensitive patients who received three or more lines of therapy and whose tumors carry a BRCA mutation or are otherwise incapable of proper DNA repair. It tests a patient’s tumor tissue for DNA repair defects, assessing mutations in the BRCA1 and BRCA2 genes, along with three biomarkers of homologous recombination deficiency — loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions. Because tumors
Subscribe or to access all post and page content.