Myriad’s Polygenic Risk Score Personalizes Risk of Breast

SALT LAKE CITY, Dec. 14, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced that results of a new validation study of the company’s polygenic risk score (PRS) for breast cancer were presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Tx.  The key finding is that the PRS significantly improves the precision and accuracy of breast cancer risk estimates for women of European ancestry who have pathogenic variants (PV) in high- and moderate-penetrance breast cancer genes.

“Our goal is to help women understand their risk of breast cancer so that they can take steps to live longer, healthier lives.  Women who have a family history of breast cancer should consider hereditary cancer testing with the myRisk Hereditary Cancer test,” said Jerry Lanchbury, Ph.D., chief scientific officer of Myriad Genetics.  “In this landmark study, we demonstrated that for women who test positive for a mutation in one of the five most common breast cancer genes, there are additional genetic factors called single nucleotide polymorphisms (SNPs) that can further influence their lifetime risk of breast cancer.” 

A summary of the study follows below.  Follow Myriad on Twitter via @myriadgenetics and keep up to date with SABCS meeting news and updates by using the #SACBS19 hashtag. 

Myriad Poster Presentation Title:  Polygenic Breast Cancer Risk Modification in Carriers of High and Intermediate Risk Gene Mutations. Presenter:   Elisha Hughes, Ph.D. Date:   Saturday, Dec. 14, 2019, 7:00–9:00 a.m. Location:  Poster P6-08-07

This validation study evaluated the 86-SNP PRS as a breast cancer risk factor for women who carry PV in the BRCA1 , BRCA2 , CHEK2 , ATM and PALB2 genes and for PV-free women.  The analysis included data from 152,012 women of European ancestry who received a myRisk ^® Hereditary Cancer test as part of their clinical hereditary cancer risk assessment.  The results demonstrated that the 86-SNP PRS significantly modified the breast cancer risk for women with pathogenic mutations in the five tested breast cancer genes (p-value <10 ^-4 ).  For some women, the PRS significantly increased the gene-based risk of breast cancer, while in others the gene-based risk was reduced (see Graph 1).  Importantly, the greatest PRS risk-modification was observed in carriers of CHEK2 , ATM and PALB2 mutations with some women reaching the risk levels associated with BRCA1 and BRCA2 mutations.  

To view  Graph 1: PRS Significantly Modifies Lifetime Breast Cancer Risk in Mutation Carriers , please visit the following link:  https://www.globenewswire.com/NewsRoom/Attach...25a578454c

“These findings mean that we have the potential to significantly improve the precision of hereditary cancer risk assessment for women who test positive for mutations in the high and intermediate risk breast cancer genes,” said Elisha Hughes, Ph.D., lead investigator and director of Bioinformatics at Myriad Genetics.  “We are optimistic that this additional genetic information can help clinicians more accurately predict the risk of breast cancer and provide the best care for their patients in the future.”

Next Steps The company plans to publish these new data in a peer reviewed medical journal and make the PRS available for U.S. women of European ancestry who test positive for mutations in breast cancer genes.  The PRS currently is available as part of myRisk ^® Hereditary Cancer enhanced with riskScore ^® for women of European ancestry who test negative for pathogenic mutations in the breast cancer genes.  Specifically, the riskScore ^® test combines the PRS with the Tyrer-Cuzick model to estimate a woman’s 5-year and lifetime risk for developing breast cancer.  The company is committed to making myRisk ^® Hereditary Cancer enhanced with riskScore ^® available to all ethnicities and is developing the test for women of Hispanic and African-American ancestry who test negative.  The company is currently conducting the largest ever PRS study in African Americans and will present the data at a future meeting.

Please visit Myriad at booth #113 to learn more about our portfolio of genetic tests for breast cancer. Follow Myriad on Twitter via @myriadgenetics and keep up to date with Symposium news by using the hashtag #SABCS19.

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 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 35 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 precision 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 critical success factors:  building upon a solid hereditary cancer foundation, 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 CDx, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, Foresight and Prequel 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 related to the Company’s polygenic risk score and data being featured at the 2019 San Antonio Breast Cancer Symposium being held Dec. 10-14, 2019 in San Antonio, Tx.; the potential to significantly improve the precision of hereditary cancer risk assessment for women who test positive for mutations in the high and intermediate risk breast cancer genes; this additional genetic information helping clinicians more accurately predict the risk of breast cancer and provide the best care for their patients in the future; publishing these new data in a peer reviewed medical journal and making the PRS available for U.S. women of European ancestry who test positive for mutations in breast cancer genes; making myRisk® Hereditary Cancer enhanced with riskScore® available to all ethnicities and developing the test for women of Hispanic and African-American ancestry who test negative; conducting the largest ever PRS study in African Americans and presenting the data at a future meeting; 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; 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 for the fiscal year ended June 30, 2019, 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.