Myriad Reports Tumor Bracanalysis CDX Has Identified 44% More Candidates for PARP Therapy

Myriad Genetics, Inc.

today announced that its Tumor BRACAnalysis CDx™ companion diagnostic test significantly improved the detection of cancer-causing BRCA 1/2 mutations by 44 percent in women with ovarian cancer. Data from this new study were presented at the 2014 European Society for Medical Oncology (ESMO) annual meeting in Madrid, Spain. "Several previous clinical studies have demonstrated that patients with germline or somatic BRCA 1/2 mutations respond to certain DNA-damaging medicines such as the platinum drugs," said Colin Hayward, M.D., European medical director at Myriad Genetics. "Tumor BRACAnalysis CDx also has the potential to greatly expand the number of ovarian cancer patients who may respond to treatment with PARP inhibitors." This study evaluated 131 previously untreated patients with high-grade ovarian cancer.Blood samples were tested for germline (hereditary) BRCA mutations.Additionally, tumor samples were obtained from patients receiving surgery and were tested for both somatic (tumor) and germline BRCA mutations. The data analysis included 92 patients who completed testing for both germline and somatic mutations.The results show that the Tumor BRACAnalysis CDx test identified 28.3 percent of women with either germline or somatic BRCA 1/2 mutations.In contrast, blood germline testing only identified the 19.6 percent of patients with germline BRCA 1/2 mutations.The somatic mutations identified by Tumor BRACAnalysis CDx testing represent a 44 percent increase in the detection of cancer-causing BRCA mutations over germline testing.           Ovarian Cancer Patients with BRCA 1/2 Mutations   Tumor BRACAnalysis Blood Germline   CDx™ Testing (N=92) BRCA Testing (N=92) BRCA 1 Mutations 12 germline 12 germline 5 somatic 0 somatic BRCA 2 Mutations 6 germline 6 germline   3 somatic 0 somatic % of mutations by 19.6% (germline) 19.6% (germline) type 8.7% (somatic) – Total % of Patients 28.3% 19.6% "In this study, tumor analysis identified substantially more patients with BRCA 1/2 mutations than germline blood testing alone," said Melinda Yates, Ph.D., of the MD Anderson Cancer Center in Houston, Texas and a study investigator. "The logical path forward is to use tumor testing to identify the greatest number of patients with BRCA 1/2 mutations."   It is estimated that 65,000 women in Europe are diagnosed with ovarian cancer annually. Ovarian cancer tends to have high mortality rates and most patients face disease recurrence with limited treatment options, and Myriad is committed to working with pharmaceutical company partners to bring promising new therapies to market to improve the treatment of this lethal disease.