Myriad presents myPath Melanoma clinical validation study results Myriad Genetics presented results from a pivotal clinical validation study of the Myriad myPath Melanoma test at the 2014 American Society of Clinical Oncology annual meeting. The Myriad myPath Melanoma test has now shown reproducible results in two large cohorts. Last November, Myriad presented results from its verification study at the American Society of Dermatopathology annual meeting. Data from that verification study of 464 lesions showed that the Myriad myPath Melanoma test had greater than a 90 percent diagnostic accuracy in differentiating malignant melanoma from benign skin lesions in a variety of subtypes. Additionally, an analysis of a prospective clinical utility study was highlighted at ASCO and initial findings from that study are consistent with earlier findings from a retrospective clinical utility study that was presented at the United States & Canadian Academy of Pathology's annual meeting in March. The USCAP data demonstrated a 33% change in medical management based upon the Myriad myPath Melanoma test result.
Myriad Genetics receives FDA approval of BRACAnalysis CDx Myriad Genetics (MYGN) announced that it has received approval from the U.S. FDA for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca's (AZN) drug Lynparza. Lynparza is the first poly ADP-ribose polymerase inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic for use with a novel PARP inhibitor. BRACAnalysis CDx is a highly accurate molecular companion diagnostic test that identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample. BRACAnalysis CDx was proven in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval of BRACAnalysis CDx demonstrates Myriad's commitment to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.