MYGN Myriad Genetics Inc

Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that results from three studies with the Myriad myRisk® Hereditary Cancer test will be featured in podium presentations at the 2016 American Society of Clinical Oncology annual meeting.  These presentations demonstrate the expanding benefits of gene panel testing and underscore the need for gene panel testing to become the standard-of-care for hereditary cancer risk evaluation.

“We’re very excited to have several podium presentations that feature the myRisk Hereditary Cancer test and advance the state-of-the-art of hereditary cancer testing and risk assessment,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories.  “There are three important findings at this year’s meeting.  First, the myRisk test identified a significant number of deleterious mutations that would otherwise have been missed by syndrome-directed testing.  Second, among patients with suspected hereditary colon cancer, myRisk identified twice as many deleterious mutations in non-Lynch Syndrome genes as in Lynch genes.  Third, the use of the myRisk test did not result in inappropriate patient care or increased distress among patients with an uncertain or negative test result.”

The results of the studies to be presented are described below and abstracts are available at: abstracts.asco.org.   Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.

myRisk Hereditary Cancer Podium PresentationsTitle:  Yield of multiplex panel testing exceeds expert opinion and validated prediction models.Presenter:  Gregory Idos, Stanford University Cancer Institute.Date:  Sunday, June 5, 2016, 9:45 - 9:57 a.m. Location:  S404, Abstract 1509.

This study evaluated the diagnostic yield and clinical utility of panel testing using the myRisk Hereditary Cancer test in 1,000 patients undergoing hereditary cancer-risk assessment.   Before testing, differential diagnoses (DDx) were generated after clinical genetics assessment.  After testing, the results showed that 11.6 percent of patients tested positive for a deleterious mutation.  The most frequently identified mutations were in BRCA1 (18 percent) and BRCA2 (18 percent), MUTYH (17 percent), APC (7 percent), CHEK2 (6 percent) and ATM (5 percent).  Importantly, 70 percent of the mutations were included in the DDx before testing.  However, 26 percent of the deleterious mutations were not clinically suspected before testing, which demonstrates the value of gene panel testing in hereditary cancer risk assessment. 

Title:  Safety of multiplex gene testing for inherited cancer risk: interim analysis of a clinical trial.Presenter:  Allison Kurian, Stanford University Cancer Institute.Date: Tuesday, June 7, 2016, 8:36 - 8:48 a.m. Location: S102, Abstract: 1503.

This study evaluated the safety of gene panel testing among patients who were undergoing cancer-risk assessment.  The interim analysis of the first 1,000 patients found that 11.6 percent had a deleterious mutation in a cancer susceptibility gene.  Overall, self-reported surgery rates were low and there was no difference between patients who had a deleterious mutation and those with a variant of uncertain significance (VUS).  Most patients never/rarely had thoughts of cancer affecting their daily activities, did not regret testing and wanted to know the results.  Patients with a deleterious mutation reported higher distress and uncertainty scores than those with a VUS or negative result.  There was no difference in distress or uncertainty among patients with a VUS or negative result.  Based on these findings, gene panel testing did not result in inappropriate medical management or increased distress/uncertainty among VUS and negative patients.

Title:  Prevalence of germline mutations in cancer risk genes among unselected colorectal cancer (CRC) patients (pts).Presenter:  Matthew Yurgelun, Dana-Farber Cancer Institute.Date:  Tuesday, June 7, 2016, 8:12 - 8:24 a.m. Location:  S102, Abstract: 1501.

This study evaluated the prevalence of deleterious mutations in 1,100 patients with colorectal cancer (CRC) who were treated at the Dana-Farber Cancer Institute.  The results showed that 10 percent of patients had a deleterious mutation: 3.1 percent in Lynch Syndrome (LS) genes and 7.1 percent in non-LS genes.  Importantly, only 35 percent of high-penetrance non-Lynch mutation carriers had clinical histories suggesting their syndrome.  Patients with non-LS mutations were more likely to have more than one CRC, family history of ovarian cancer, and somatic KRAS G12C mutations relative to patients with no deleterious mutations.

About Myriad myRisk® Hereditary Cancer TestingThe Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms in an 850 step laboratory process to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.  For more information visit: https://www.myriad.com/products-services/hereditary-cancers/myrisk-hereditary-cancer/.

About Myriad GeneticsMyriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs.  Myriad is focused on three strategic imperatives:  transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets.  For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the presentation of data from three clinical studies at the 2016 American Society of Clinical Oncology annual meeting to be held June 3-7, 2016 in Chicago, Ill; key podium presentations highlighting the safety and validity of the myRisk Hereditary multigene panel test in assessing hereditary cancer risk; the myRisk Hereditary Cancer studies presented at ASCO advancing the state-of-the-art of hereditary cancer testing; the new data providing additional evidence for the safety and clinical utility of the myRisk Hereditary Cancer test to help improve and save the lives of patients; and the Company's strategic directives under the caption "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 molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in 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; risks related to increased competition and the development of new competing tests and services; 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 licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; 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 our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; 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 or other intellectual property; 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 of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2015, which has been 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.

Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com

Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com