Myriad Applauds AACU Position Statement on Molecular Testing for Risk Stratification in Prostate Cancer
SALT LAKE CITY, March 06, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a worldwide leader in personalized medicine, announced today that the American Association of Clinical Urologists (AACU) have issued a position statement supporting molecular testing for prostate cancer patients, which was also endorsed by the Large Urology Group Practice Association (LUGPA). The statement supports tissue based molecular testing for prostate cancer risk stratification in low and favorable-intermediate risk men and germline testing for hereditary cancer syndrome in prostate cancer patients with a family history of cancer or high-risk disease.
"The AACU is very pleased to release our position statement on genomic testing in prostate cancer. Together, with LUGPA, our organizations represent more than 70 percent of urologists in the United States. The statement is in close alignment with the recently updated NCCN prostate cancer guidelines. Importantly, it sends a message to policy makers, researchers, payers and patients and their families that we are committed to applying the best available science to the detection, risk stratification and appropriate treatment of prostate cancer," said Mark T. Edney, M.D., MBA, chair, State Advocacy Network at the AACU. "Further, our organizations seek to assist in finding the families who reside in our communities who may be harboring crucial and unknown hereditary genes that may affect their cancer risk, that of their relatives, and of future generations."
Below are the recommendations stated in the AACU position paper:
- Tissue-based molecular testing for risk stratification should be considered for low and favorable-intermediate risk men with life expectancy ≥ 10 years.
- Germline testing should be considered in men with very-low risk, low risk, favorable and unfavorable intermediate risk prostate cancer and strong family history. Germline testing also should be considered, irrespective of family history, in men with metastatic disease or those with high risk or very-high risk regional disease.
The position paper issued by AACU and endorsed by LUGPA is consistent with recently issued National Comprehensive Cancer Network (NCCN) guidelines supporting biomarker based testing in prostate cancer. Myriad has the market leading prostate cancer prognostic test Prolaris® and the market leading hereditary cancer risk assessment test myRisk® Hereditary Cancer.
"With recent endorsements from NCCN, AACU, and LUGPA, Prolaris and myRisk Hereditary Cancer testing should now be considered standard-of-care tests to help guide key decision making for prostate cancer patients," said Nicole Lambert, general manager, Urology at Myriad Genetics. "We are highly optimistic that these broadly supported recommendations will lead to expanded reimbursement coverage and improved patient access to these important tests."
About American Association of Clinical Urologists:
About the American Association of Clinical Urologists: Founded in 1968 by urologists concerned by the government's increasing role in the practice of medicine, the American Association of Clinical Urologists (AACU) is the only national organization to serve urology with the sole purpose of promoting and preserving the professional autonomy and financial viability of each of its members. The AACU is dedicated to developing and advancing health policy education as it affects urologic practice in order to preserve and promote the professional autonomy of its members and support the highest quality of care for patients. The AACU is a member of the American Medical Association Federation of Medicine and proud sponsor of UROPAC.
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 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 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 American Association of Clinical Urologists (AACU) position statement and recommendations supporting molecular testing for prostate cancer patients; the Company's optimism that these broadly supported recommendations will lead to expanded reimbursement coverage and improved patient access to these important tests; 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 our 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 Annual report on Form 10-K for the fiscal year ended June 30, 2017, 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.