Myriad Genetics to Share New Data at 2021 ASCO Validating Personalized Breast Cancer Risk Assessments for Women of All Ancestries
Study Is First to Validate New Polygenic Risk Assessment for All; Company Aims to Improve Access and Reduce Disparities in Genetic Testing
SALT LAKE CITY, May 19, 2021 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, today announced that it will present results from a study with more than 275,000 women validating the use of a new method for polygenic breast cancer risk assessments in women of all ancestries. The new data will be shared in an oral presentation with leading collaborators on June 4 at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
“The polygenic risk score (PRS) is one of the most powerful risk prediction tools in the field of breast cancer, and until now a validated model had not been available to assess women of all ancestries,” said Holly Pederson, M.D., director of Medical Breast Services at Cleveland Clinic and presenter of the study. “Our data now provide a framework for a PRS that delivers a personalized genomic breast cancer risk assessment to any and all interested women. The updated PRS, validated and well-calibrated, may be the most exciting clinical development in risk stratification since multi-gene panel testing.”
Myriad Genetics currently offers its riskScore® PRS tool to women at no additional cost as part of the market-leading Myriad myRisk® Hereditary Cancer test. riskScore provides more comprehensive, personalized and actionable insight for women who qualify for myRisk. It incorporates more than 90 validated genetic markers and offers a precise estimate of a 5-year and lifetime risk to develop breast cancer.
“With this new study (abstract #10502), we are taking an important step to expand the ability of riskScore to benefit more women, making it the industry’s most inclusive breast cancer risk assessment PRS tool,” said Nicole Lambert, president of Myriad Genetic Laboratories. “Myriad Genetics is the first to validate a PRS for women of all ancestries. This reinforces our mission to advance health and wellbeing for all and reduce healthcare disparities.”
According to the American Cancer Society, the average risk of a woman in the United States to develop breast cancer in her lifetime is about 13%, or a one in eight chance. It is estimated there will be 281,550 new cases of breast cancer diagnosed in the U.S. and around 43,600 deaths in 2021.
“These new findings will empower more women to take control of their health and enable healthcare providers to better diagnose and treat patients,” said Thomas Slavin, M.D., senior vice president of Medical Affairs for Oncology at Myriad Genetics and a co-author of the new validation study. “Tools such as PRS can help clinicians and patients make more informed decisions about how to manage their precise breast cancer risk.”
Myriad Genetics plans to launch riskScore for all ancestries later this year as part of its myRisk clinical test. In addition, the company recently announced plans to launch a standalone consumer version of riskScore in 2022. The consumer version will further expand riskScore access to a new population of 93 million women who do not already qualify for hereditary cancer testing due to their personal or family history.
Follow Myriad Genetics on Twitter via @myriadgenetics and keep up to date with ASCO 2021 meeting news and updates by using the #ASCO21 hashtag.
riskScore for all ancestries is a clinically validated precision medicine tool that enhances the Myriad myRisk Hereditary Cancer test. The test incorporates data from more than 90 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer. It previously was validated to predict breast cancer risk in women of European descent and is now validated for all ancestries. This data is then combined with a personal and family history algorithm, the Tyrer-Cuzick model, to provide an individualized breast cancer risk assessment.
About Myriad myRisk Hereditary Cancer
The Myriad myRisk Hereditary Cancer test uses advanced 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 is a leading genetic testing and precision medicine company dedicated to advancing health and wellbeing for all, empowering individuals with vital genetic insights and enabling healthcare providers to better detect, treat and prevent disease. Myriad discovers and commercializes genetic tests that determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across medical specialties where critical genetic insights can significantly improve patient care and lower healthcare costs. For more information, 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, EndoPredict, 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 the results and impact of a new study that validates the use of a new method for polygenic breast cancer risk assessments in women of all ancestries; the study helping more women take control of their health by understanding their risk of developing breast cancer; the expansion of the Company’s current riskScore offering to all women who meet clinical criteria and qualify for hereditary cancer testing, regardless of ancestry; the Company’s plan to launch a standalone consumer version of riskScore in 2022; 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 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 associated with COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline or that we may not be able to operate our business on a profitable basis; risks related to our ability to generate sufficient revenue from our existing product portfolio or in launching and commercializing new tests; risks related to changes in governmental or private insurers’ coverage and 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 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; 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 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; 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; risks related to the material weakness identified in our internal control over financial reporting, including the impact thereof and our remediation plan; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our Transition Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2021, 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.
|Media Contact:||Jared Maxwell||Investor Contact:||Nathan Smith|
|(801) 505-5027||(801) 505-5067|