Myriad presents tumor BRACAnalysis CDx study at ESMO

Tumor BRACAnalysis CDx identifies 44 percent more candidates for PARP therapy

2014-09-29

(Press-News.org) SALT LAKE CITY, Utah, Sept. 29, 2014 – Myriad Genetics, Inc. (Nasdaq: MYGN) today announced that its Tumor BRACAnalysis CDx™ companion diagnostic test significantly improved the detection of cancer-causing BRCA1/2 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 BRCA1/2 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 BRCA1/2 mutations. In contrast, blood germline testing only identified the 19.6 percent of patients with germline BRCA1/2 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 BRCA1/2 Mutations

Tumor BRACAnalysis CDx™ Testing (N=92) Blood Germline BRCA Testing (N=92) BRCA 1 Mutations 12 germline
5 somatic 12 germline
0 somatic BRCA 2 Mutations 6 germline
3 somatic 6 germline
0 somatic % of mutations by type 19.6% (germline)
8.7% (somatic) 19.6% (germline)
– 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.

INFORMATION:

About Tumor BRACAnalysis CDx™

Myriad's Tumor BRACAnalysis CDx is the most robust and accurate companion diagnostic test for identifying both germline (hereditary) and somatic (tumor) cancer-causing mutations in the BRCA1 and BRCA2 genes. Tumor BRACAnalysis CDx has undergone significant analytic validation and has been shown to identify 44 percent more patients with cancer-causing BRCA 1/2 mutations compared to germline testing alone. Myriad is actively collaborating with leading pharmaceutical companies to develop Tumor BRACAnalysis CDx as a companion diagnostic for use with certain PARP inhibitors, platinum-based drugs and other chemotherapeutic agents. In the United States, the testing will be done at the Company's laboratory in Salt Lake City. In Europe, the test will be performed at the Company's Munich laboratory. Prescribing physicians will receive Tumor BRACAnalysis CDx test results in approximately two weeks.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com. Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra DA and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the presentation of the Tumor BRACAnalysis CDx companion diagnostic test data at the 2014 ESMO Annual Meeting; the effectiveness of the Tumor BRACAnalysis CDx test; the Company's belief that the Tumor BRACAnalysis CDx companion diagnostic test represents a significant advancement in the identification of BRCA mutations; the clinical use of the Tumor BRACAnalysis CDx test as companion diagnostic; the Company's belief that the Tumor BRACAnalysis CDx test will improve the standard of care for patients with ovarian cancer; and the Company's strategic directives under the captions "About Tumor BRACAnalysis CDx" and "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that we may not be successful in transitioning from our existing product portfolio to our new products, such as our myRisk Hereditary Cancer test, which represents the next generation of our existing hereditary cancer franchise; the risk that we may not be able to generate sufficient revenue from our existing tests and our new tests or develop new tests; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to increased competition and the development of new competing tests and services; risks related to our projections about the potential market opportunity for our products; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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Myriad presents tumor BRACAnalysis CDx study at ESMO

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