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News Release - September 15, 2017
Myriad Genetics Announces Positive Data Supporting New riskScore(TM) Test at the 36th Annual Conference of the National Society of Genetic CounselorsValidation of Residual Risk Score to Predict Breast Cancer Risk in Women without Hereditary Cancer Mutations Is Highly Statistically Significant
SALT LAKE CITY, Sept. 15, 2017 -- (Healthcare Sales & Marketing Network) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that two important studies will be featured in podium presentations at the 36th annual conference of the National Society of Genetic Counselors (NSGC) in Columbus, OH.
“We look forward to presenting our pioneering research at NSGC this year and bringing forward new innovations that are changing how a woman’s risk of breast cancer is being managed and improving the lives of even more people,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “We are particularly excited to present the results of a large study of our new hereditary cancer test, called riskScore, that we believe will help genetic counselors and doctors improve care for their unaffected patients who test negative for a hereditary mutation. We’re also looking forward to presenting data from a study that evaluated variant reclassification in 1.4 million patients tested for hereditary cancer risk assessment over a 10 year period.”
More information about the company’s presentations can be found at: www.nsgc.org/conference. Follow Myriad on Twitter via @MyriadGenetics and stay informed about conference news and updates by using the hashtag #NSGC17.
myRisk® Hereditary Cancer with riskScore™ Podium Presentation
Title: Development and Validation of a Residual Risk Score to Predict Breast Cancer Risk in Unaffected Women Negative for Mutations on a Multi-Gene Hereditary Cancer Panel.
Presenter: Elisha Hughes, Ph.D.
Date: Saturday, Sept. 16, 2017, 11:30–11:45 a.m.
Location: Platform Presentation, #1131
This study evaluated 86 single nucleotide polymorphisms (SNPs) as breast cancer risk factors through the validation of a polygenic residual risk score in large, consecutive cohorts of more than 17,205 women of European ancestry who tested negative for mutations in known breast cancer susceptibility genes. The results show that the 86 SNP residual risk score was highly predictive of breast cancer risk in unaffected women of European ancestry with a family cancer history who tested negative for germline mutations in known breast cancer risk genes (p<10-50). The clinical implementation of a residual risk score for women at risk for hereditary breast cancer may offer significant potential for the management of high-risk, unaffected women who test negative for monogenic mutations in breast cancer-risk genes.
“As healthcare providers our goal is to help patients understand their risk of breast cancer so that they personalize their medical care and live healthier lives. Women who have not yet developed cancer but have a family history of breast cancer should consider hereditary cancer testing with multi-gene panels,” said Ora Gordon, M.D., medical director at the Center for Clinical Genetics & Genomics, Providence Health & Services Southern California. “Despite being at high familial risk for breast cancer, in reality, most patients will not carry a hereditary mutation in a breast cancer-risk gene, which doesn’t mean they’re risk free. For patients who test negative, there are other factors including SNPs, family history of cancer and personal factors that may increase the risk of breast cancer. The new riskScore test combines this data to provide patients with additional information about their individual risk for developing breast cancer in five years and over their lifetime to confirm whether high risk interventions are still needed despite negative single gene testing results. It can also provide reassurance that routine surveillance is appropriate despite having a family history. This is a much needed and long awaited advance in the personalization of breast cancer risk.”
myRisk® Hereditary Cancer Podium Presentation
Title: Variant Reclassification in a Clinical Cohort: A Decade of Experience.
Presenter: Nichole Brown, MS, CGC.
Date: Friday, Sept. 15, 2017, 3:15–3:30 p.m.
Location: Platform Presentation, #1394
This study assessed variant reclassification in 1.4 million patients tested for hereditary cancer risk assessment between 2006 and 2016. Of these, 96 percent were female, 52 percent were of European decent and the median age was 49 years. Approximately 56 percent had a personal history of cancer at the time of testing. Approximately 36,264 unique variants (mutations) were identified during testing and 293,496 total variants were reported. The results show that when a comprehensive classification approach is employed, variant re-classification is relatively common (~19 percent) in genetic testing for hereditary cancer risk.
“Accurate classification of genetic variants can significantly impact on clinical care of patients and highlights the need timely reclassification and notification. Our ultimate goal is to definitively classify all genetic mutations, which is why Myriad invests so heavily in variant classification research and through scientific collaborations and publications,” said Lancaster.
“Importantly, Myriad’s commitment to patients doesn’t stop once we’ve given them a test result. We understand that science evolves and that’s why we have a commitment to notify doctors when we learn new information that could affect patient care. We offer support to patients and their families that lasts a lifetime.”
riskScore is a new clinically validated personalized medicine tool that enhances Myriad’s myRisk® Hereditary Cancer test. riskScore helps to further predict a women’s lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from greater than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was validated in our laboratory to predict breast cancer risk. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk. riskScore is offered free-of-charge as an added service to Myriad’s myRisk Hereditary Cancer test.
About Myriad myRisk® Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 28 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.
About Myriad Genetics
Myriad 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 five strategic imperatives: stabilizing hereditary cancer revenue, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. 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, EndoPredict, Vectra, GeneSight, riskScore 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 Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to two important studies being featured in podium presentations at the 36th annual conference of the NSGC in Columbus, OH; new innovations changing how a woman’s risk of breast cancer is managed and improving the lives of people; riskScore helping genetic counsellors and doctors improve care for their unaffected patients who test negative for a hereditary mutation; the clinical implementation of a residual risk score for women at risk for hereditary breast cancer offering significant potential for the management of high-risk, unaffected women who test negative for monogenic mutations in breast cancer-risk genes; the Company’s commitment to notify doctors when we learn new information that could affect patient care; offering support to patients and their families that lasts a lifetime; 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 described or implied in the forward-looking statements. These risks 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 our ability to transition from our existing product portfolio to our new tests; 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; 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 tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with 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, including but not limited to our acquisition of Assurex, Sividon and the Clinic; 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; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K, 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.
Source: Myriad Genetics
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