Myriad Genetics Presents New Data on Its Companion Diagnostic and Prostate Cancer Tests at the European Society for Medical Oncology Annual Meeting

Myriad Genetics, Inc.

, a leader in molecular diagnostics and personalized medicine, today announced three poster presentations that will be featured at the 40th European Society for Medical Oncology (ESMO) meeting being held Sept. 25 to 29, 2015 in Vienna, Austria. The presentations include new studies on the myChoice™ HRD and Tumor BRACAnalysis CDx™ companion diagnostic tests and final results from the EMPATHY-P clinical utility study on Prolaris®. "Myriad continues to place a strong emphasis on molecular diagnostic research with the goal of enabling personalized medicine and improving patient outcomes. We are presenting exciting new data on the unique ability of our companion diagnostics to identify the highest number of patients who may benefit from drugs that target the DNA-repair pathway, such as PARP inhibitors," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad. "We're also presenting the final results for the EMPATHY-P study that show the Prolaris test provides essential clinical information to help physicians select men with prostate cancer who are good candidates for active surveillance versus those who need more medical treatment based on a genetic evaluation of their tumor." The list of key Myriad presentations at ESMO (#ECC2O15) follows. myChoice™ HRD Title: DNA Repair Deficiencies in Ovarian Cancer: Genomic Analysis of High Grade Serous Ovarian Tumors from the NOVA Study. Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST. Location: Hall C, Poster P108. Homologous recombination deficiency was assessed on tumors obtained from 318 patients enrolled in the NOVA study, a Phase 3 clinical trial evaluating the PARP inhibitor niraparib as a treatment in patients with platinum-sensitive ovarian cancer. The results show that 100 percent of patients with a germline BRCA mutation and 55 percent of patients without a BRCA mutation were HRD positive as determined by the myChoice HRD test. Importantly, the myChoice HRD test, which uses three novel algorithms of DNA damage (LOH, LST, TAI), more clearly defined the HRD positive population in ovarian cancer than did LOH alone. These findings support the use of the myChoice HRD test to more effectively identify patients who may benefit from therapy with DNA-damaging agents, such as platinum drugs and PARP inhibitors. Tumor BRACAnalysis CDx™ Title: Next Generation Sequencing of BRAC1 and BRCA2 Genes in Ovarian Tumors Captures Germline Mutations and Expands the Potential Treatment Group for the PARP Inhibitor Olaparib. Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m. CEST. Location: Hall C, Poster P116. This study assessed the ability of Tumor BRACAnalysis CDx, a tumor-based next generation sequencing (NGS) test, to detect germline BRAC1/2 mutations in patients with high-grade serous ovarian cancer versus germline testing using Sanger sequencing in a reference laboratory. Tumor tissue was available from 54 patients to evaluate the Tumor BRACAnalysis CDx test. In all 54 cases, Tumor BRACAnalysis CDx correctly identified the deleterious BRAC1/2 mutations, demonstrating 100 percent sensitivity. The study also showed that tumor cells have de novo somatic mutations not identifiable via germline testing alone. For example, Tumor BRACAnalysis CDx found 12 somatic BRCA1/2 mutations, which represents an increase of 22 percent over germline testing in a sample set that had been specifically enriched for germline mutations. Importantly, patients with germline and tumor BRAC1/2 mutations showed similar treatment response to olaparib, suggesting that tumor testing effectively identifies patients appropriate for treatment with PARP inhibitors. Prolaris® Title: Potential Reduction of Overtreatment of Localized Prostate Cancer Using a Cell Cycle Gene Expression Assay (Prolaris) in Biopsy Specimens: Results from the European Multi-Center EMPATHY-P Study. Date: Monday, Sept. 28, 2015: 4:45 to 6:45 p.m. CEST. Location: Hall C, Poster P072. The EMPATHY-P study evaluated the Prolaris test in 502 patient biopsy samples to determine the aggressiveness of prostate cancer in these newly diagnosed patients from five European countries including: Italy, Germany, Spain, Switzerland and the UK. The patients' biopsy samples also were evaluated using standard clinical pathology methods (D'Amico/AUA risk stratification) that were then compared to the Prolaris test results. The EMPATHY-P data show that overall the Prolaris test identified 54 percent of the European men with a risk profile that was different than would be expected using standard clinical pathology. Specifically, the EMPATHY-P study demonstrated that the Prolaris test score found 24 percent of European men had less aggressive prostate cancer and 30 percent of patients had more aggressive disease compared to standard clinical pathology measurements. These data demonstrate that the Prolaris test score can be used to personalize risk assessment for men with localized prostate cancer and identify good candidates for active surveillance.