Myriad Genetics Presents Pivotal Validation Study for New riskScore™ Test at the 2017 San Antonio Breast Cancer Symposium
SALT LAKE CITY, Dec. 06, 2017 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced results from a ground-breaking validation study to better define the risk of breast cancer in women of European ancestry who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test. The results are being featured in a Spotlight presentation today at the 2017 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.
"Myriad Genetics is the first to bring to market a comprehensive approach to lifetime breast cancer risk assessment that includes 28 genes, family history evaluation, and well-validated SNPs through riskScore," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. "This comprehensive approach delivers the most precise tool in the industry to help physicians assess a patient's breast cancer risk and empower choices that may prevent a patient's breast cancer from ever happening."
A summary of this study appears below and more information about the company's presentation can be found at: https://www.sabcs.org/2017-SABCS. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS17.
myRisk® Hereditary Cancer with riskScore™ Spotlight Presentation
Title: Development and Validation of a Combined 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: Wednesday, Dec. 6, 2017, 5:00—7:00 p.m.
Location: Poster Discussion, PD1-08
This study was designed to validate the new riskScore™ test's ability to predict the 5-year and lifetime risk of breast cancer compared to the Tyrer-Cuzick model alone. riskScore is a novel test that combines data from the Tyrer-Cuzick model with 86 genetic markers, called single nucleotide polymorphisms (SNPs), to comprise a combined risk score that accounts for clinical, familial and genetic variables.
The validation study included 1,617 women: 990 women with breast cancer and 627 controls. The results show that riskScore is a highly statistically significant predictor of the 5-year and lifetime risk of breast cancer (p=5.2x10-39 and p=4.1x10-35, respectively). Moreover, riskScore was statistically significantly superior to Tyrer-Cuzick alone for both 5-year and lifetime risk of breast cancer (1.0x10-12 and 8.3x10-13, respectively), underscoring the important contribution of the SNPs to the test.
"The combination of the SNP panel with Tyrer-Cuzick provides even greater precision than previously demonstrated from family history models," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics. "As a result, we believe our myRisk Hereditary Cancer test, now enhanced with riskScore, provides the most comprehensive breast cancer risk assessment available today."
In a separate analysis, the riskScore test was applied to a real-world cohort of 6,479 women who tested negative for mutations in 11 genes associated with hereditary breast cancer to determine their remaining lifetime risk of developing breast cancer. The results show that riskScore remaining lifetime risk estimates ranged from 0.88 percent to 66.4 percent (Graph 1). Additionally, 38.2 percent of patients tested with riskScore had a lifetime risk >20 percent and 7.4 percent had a lifetime risk >3 times the general population (35 percent).
"These data confirm the important contribution of SNPs to breast cancer risk assessment in unaffected women who test negative for mutations in hereditary breast cancer genes with a precise measure of breast cancer risk," said Lanchbury. "The addition of the SNP data appears to be especially helpful in identifying those patients at higher risk for developing breast cancer."
"Patients who are above 20 percent lifetime risk are candidates for additional screening based on U.S. Preventive Services Task Force recommendations and those above 35 percent may be candidates for more aggressive medical interventions," said Lancaster. "Importantly, these data show that riskScore identifies a larger number of high-risk patients than either BRCA1 or BRCA2 testing and represents the next major epoch in hereditary cancer risk assessment and patient care."
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 in women of European descent. 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.
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 the presentation of the Company's riskScore validation study at the 2017 San Antonio Breast Cancer Symposium; the ability of riskScore to predict 5-year and lifetime risk of breast cancer in women who test negative for hereditary breast cancer mutations; the Company's belief that its myRisk hereditary cancer test, now enhanced with riskScore, provides the most comprehensive breast cancer risk assessment available today; the utility of the additional SNP data in identifying those patients at higher risk for developing breast cancer; the number of patients who are candidates for additional screening based on U.S. Preventive Services Task Force recommendations and the number of patients who may be candidates for more aggressive medical interventions; riskScore identifying a larger number of high-risk patients than either BRCA1 or BRCA2 testing; the Company's belief that riskScore represents the next major epoch in hereditary cancer risk assessment and patient care; 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.