Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a clinical study finding that the Myriad diagnostic device accurately identifies patients for olaparib treatment.
Commenting on the results of the clinical study, Johnathan Lancaster, M.D. Ph.D., Gynecologic Oncologist and Chief Medical Officer of Myriad Genetic Laboratories, stated that:
These outstanding findings represent another meaningful advancement for ovarian cancer patients. Importantly, the results demonstrated that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.
According to the press release, the BRACAnalysis CDx® test is an FDA approved diagnostic device that detects and classifies mutations in the BRCA1 and BRCA2 genes, using genomic DNA obtained from whole blood samples from a patient. Mutations in BRCA1 and BRCA2 are known to be associated with Hereditary Breast and Ovarian Cancer (HBOC) Syndrome. These mutations can be detected and quantified using the BRACAnalysis CDx® detection platform. In its Press Release, Myriad announced that BRACAnalysis CDx® may be used to aid in the identifying ovarian cancer patients who would be eligible for treatment with olaparib.
According to its website, Olaparib (Lynparza) is an FDA-approved targeted therapy for cancer, developed by AstraZeneca. Olaparib is a poly ADP ribose polymerase (PARP) inhibitor. Olaparib prevents PARP DNA repair, resulting in a buildup of damaged DNA, and resulting in cell death. Olaparib acts against hereditary BRCA1 or BRCA2 mutations.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Office of AstraZeneca stated that:
We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial. We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer. We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.
According to its website, Myriad Genetics is a molecular diagnostic company that develops diagnostic assays for the detection of genetic diseases. Specifically, these assays are said to determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, measure disease activity, and guide treatment decisions. Myriad states that it discovered and sequenced the breast cancer gene, BRCA1 in 1994, and has developed numerous diagnostic products related to the diagnosis of hereditary cancers.