Myriad Validates Polygenic Score to Predict Breast Cancer Risk in Women of Hispanic Ancestry Who Test Negative for Hereditary Cancer Mutations

Globe Newswire 6-Dec-2018 8:30 AM

SALT LAKE CITY, Dec. 06, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced results from an important study to validate the polygenic component of a forthcoming riskScore™ test for Hispanic women who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test.  The results are being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.  

Graph 1: Polygenic Score Accurately Predicts Risk of Breast Cancer in Unaffected Hispanic women with a Negative myRisk® Hereditary Cancer Test Result
*Hispanic Residual Risk Score Relative Risk



"A year ago, we launched riskScore as a significant enhancement to myRisk® to provide women of European ancestry with additional genetic information about their lifetime risk of developing breast cancer," said Jerry Lanchbury, Ph.D., chief scientific officer, Myriad Genetics.  "This year we are excited to presents results from almost 14,000 women which is the largest polygenic study ever conducted for Hispanic ancestry.  It is another step in our commitment to make riskScore accessible to all women, including those most underrepresented in our health care system."

The key data being presented at SABCS are summarized below.  Please visit Myriad at Booth #1001 to learn more about genetic testing for breast cancer.  Follow Myriad on Twitter via @myriadgenetics and keep up to date with Symposium news and updates by using the hashtag #SABCS18.

Polygenic Score Poster Presentation
Title:  Development and Validation of a Polygenic Score to Predict Breast Cancer Risk in Unaffected Hispanic Women Negative for Mutations on a Multigene Hereditary Cancer Panel.
Presenter:  Elisha Hughes, Ph.D.
Date:  Friday, Dec. 7, 2018, 5:00 – 6:00 p.m.
Poster: P5-10-02

This study evaluated 87 single nucleotide polymorphisms (SNPs) as breast cancer risk factors through the validation of a polygenic score in 8,487 women of Hispanic ancestry.  The results show that the 87-SNP polygenic score was highly predictive of breast cancer risk in unaffected Hispanic women with a significant family cancer history who tested negative for germline mutations in known breast cancer risk genes (p=7.1x10-19).  Estimates of relative risk due to SNPs ranged from 0.2 to 3.6 (Graph 1). The clinical implementation of riskScore for women of Hispanic ancestry may significantly improve the management of high-risk Hispanic women who test negative for mutations in with the myRisk Hereditary Cancer test. 

"In this study, we identified a novel SNP-based polygenic score that provides significant breast cancer predictive value in individuals of Hispanic ancestry," said Lanchbury.  "Our next task is to validate the combination of the polygenic score with the Tyrer-Cuzick model in Hispanic women."

About riskScore
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 more 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 a value-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 29 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 announced study results validating the polygenic component of a forthcoming riskScore™ test for Hispanic women who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test; the results being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas; the introduction of a riskScore test for Hispanic women who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test; the Company's commitment to make riskScore accessible to all women, including those most underrepresented in our health care system; 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, Crescendo, Sividon and Counsyl; 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.

Media Contact: Ron Rogers Investor Contact: Scott Gleason
  (908) 285-0248   (801) 584-1143
  rrogers@myriad.com   sgleason@myriad.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/baf72eac-90bc-48ee-9e59-4b98dbeafb4c

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