German Federal Joint Committee (G-BA) Issues Nationwide Reimbursement Decision for EndoPredict® Breast Cancer Prognostic Test
Myriad Genetics (NASDAQ: MYGN) announced that its EndoPredict® breast cancer prognostic test has received a positive evaluation from Germany's Federal Joint Committee (G-BA). This approval allows EndoPredict to be available for all patients with statutory health insurance in Germany, aiding in personalized chemotherapy decisions for early-stage breast cancer patients. The test has been recommended globally by several medical guidelines and is already accessible in multiple European countries. Myriad aims to expand access to this critical test in the German healthcare system.
- EndoPredict approved for statutory health insurance patients in Germany, enhancing patient access.
- Test aids in personalized treatment decisions for early-stage breast cancer, potentially increasing its demand.
- EndoPredict recognized in major national and international medical guidelines, establishing credibility.
- Dependence on reimbursement decisions may impact future sales and profit margins.
- Risks associated with competition in the molecular diagnostics market.
/NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES/
SALT LAKE CITY, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics and precision medicine, announced today that the German Federal Joint Committee (G-BA) has successfully completed the method evaluation assessment for the EndoPredict® breast cancer prognostic test. The positive decision means that EndoPredict can be made available to all patients with statutory health insurance in Germany as a benefit of the statutory health insurance scheme.
EndoPredict is a second-generation biomarker test used to determine the risk of recurrence in patients with early-stage breast cancer (ER+/HER2-). The genomic test helps patients and physicians jointly decide for, or against, chemotherapy when uncertainties exist in the assessment of the expected benefit of chemotherapy.
"This decision (by G-BA) makes it possible for a biomarker test to be carried out quickly in Germany, providing more certainty with the difficult decisions relating to the pros and cons of chemotherapy," says Univ Prof. Dr. Marion Kiechle, Director of the Gynaecological Clinic of the University Hospital Rechts der Isar of the TU Munich.
Every year, approximately 70,000 women in Germany are diagnosed with early-stage, breast cancer. For up to 20,000 of these patients, clinical-pathological criteria alone are not sufficient to confidently make chemotherapy treatment decisions. The Federal Joint Committee supports the use of biomarkers, now including EndoPredict, to identify those patients who will likely benefit from chemotherapy treatment.
EndoPredict has been part of the recommendations of the leading national (AGO, S3) and international (St.Gallen, ESMO, ASCO and NCCN) guidelines for many years and is already available to affected women in public health systems in France, England, Italy, Spain, Switzerland and Austria.
"We are pleased to make EndoPredict broadly available to gynecologists and pathologists in Germany within the framework of the GKV,” said Raymond Francot, executive vice president of Myriad International. “This decision expands access to critical, life-changing insights for patients and their providers, and adds valuable information to aid in personalized treatment selection.”
About EndoPredict®
EndoPredict is a second-generation, 12-gene molecular prognostic test for patients diagnosed with breast cancer. The test provides vital information that helps clinicians devise personalized treatment plans for their patients. EndoPredict has been validated in more than 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 30,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: https://myriad-oncology.com/endopredict/
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 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 EndoPredict being available to all patients with statutory health insurance in Germany without restrictions; EndoPredict being broadly available to gynecologists and pathologists in Germany; G-BA’s decision expanding access to critical, life-changing insights for patients and their providers; 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, 2020, 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.
| Media Contact: | Jared Maxwell | Investor Contact: | Scott Gleason | |
| (801) 505-5027 | (801) 584-1143 | |||
| jmaxwell@myriad.com | sgleason@myriad.com |
FAQ
What is EndoPredict and how does it benefit patients with breast cancer?
When was EndoPredict approved for use in Germany?
How does the approval of EndoPredict affect Myriad Genetics (MYGN)?
What are the risks associated with the approval of EndoPredict for Myriad Genetics?
Which countries already offer EndoPredict before the German approval?
