Myriad Presents New Data at ASCO Validating the Ability of riskScore® to Provide Personalized Breast Cancer Risk Information to Patients
SALT LAKE CITY, May 29, 2020 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, today announced the presentation of two new studies at the 2020 American Society of Clinical Oncology (ASCO) annual meeting demonstrating the ability of Myriad’s riskScore® test to provide personalized breast cancer risk information that allows patients and physicians to make better informed clinical treatment decisions.
“We are excited to further demonstrate Myriad’s commitment to providing the best possible risk assessment tools to patients through innovation,” said Nicole Lambert, president of Myriad Oncology, Myriad Women’s Health and Myriad International. “The validation data we are presenting at ASCO this year will support a broader launch of riskScore to even more women in the coming year with more personalized information and the unique ability to modify carrier risk through a clinically validated tool.”
Summaries of the studies are below. Follow Myriad on Twitter via @myriadgenetics and keep up to date with ASCO meeting news and updates by using the #ASCO20 hashtag.
riskScore Presentations at 2020 ASCO:
Title: Comprehensive breast cancer (BC) risk assessment for CHEK2 carriers incorporating a polygenic risk score (PRS) and the Tyrer-Cuzick (TC) model Presenter: Mark E. Robson, MD, Memorial Sloan Kettering Cancer Center Location: https://meetinglibrary.asco.org/record/187438/abstract
In this study, 358,471 women with hereditary cancer risk who were tested with a multigene panel were assessed to find 4,331 women who were carriers of deleterious CHEK2 mutations. These patients were used to develop a mathematical model to assess risk status using family history information and Myriad’s riskScore test. This model was then validated in an independent cohort of 459 women. In CHEK2 pathogenic variant carriers, a significant correlation was detected of CHEK2 status with family history (FH) (p=4.1 × 10-17) and of polygenic risk scores with FH among CHEK2 carriers (p=1.7× 10-5). Among the patients in the validation cohort, 24.0% of CHEK2 carriers were categorized as low risk (<20%), and 62.6% were categorized as moderate risk (20-50%). For 13.4% of CHEK2 carriers, risk estimation incorporating PRS and TC generated BC risks of greater than 50%, consistent with genes recognized as highly penetrant.
To view Graph 1: Precision Breast Cancer Risk Categorization of CHEK2 Carriers, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/1a4a8828-8282-47df-9e4d-b82f11604b2b
Title: Performance of the IBIS/Tyrer-Cuzick (TC) Model by Race/Ethnicity in the Women’s Health Initiative Presenter: Allison W. Kurian, M.D., M.Sc, Stanford University Location: https://meetinglibrary.asco.org/record/185965/abstract
In this study, 91,893 women of differing racial identities with no personal history of breast cancer were followed for a median of 18.9 years to assess incidence of breast cancer. 6,836 new cases of breast cancer were diagnosed among the women. The Tyrer-Cuzick model was used to assess risk of breast cancer and then actual cases of breast cancer were compared to expected cases based upon the Tyrer-Cuzick risk assessment. The study found that the Tyrer-Cuzick model was an accurate predictor of breast cancer risk among various ethnicities except for Hispanic women where it overestimated breast cancer risk (ratio of observed versus expected cases overall was 0.95).
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 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 CDx, Vectra, Prequel, Foresight, 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 related to a broader launch of riskScore to even more women in the coming year with more personalized information and the unique ability to modify carrier risk through a clinically validated tool; 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: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; 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 decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); 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.
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