The EndoPredict® Test Receives Positive Coverage Decisions from Multiple Blue Cross Blue Shield Affiliate Plans
SALT LAKE CITY, Jan. 06, 2017 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in personalized medicine, today announced that multiple Blue Cross Blue Shield (BCBS) affiliate plans have issued positive coverage determinations for EndoPredict®, including Independence Blue Cross, Blue Cross and Blue Shield of Kansas, Blue Cross and Blue Shield of Kansas City, Horizon Blue Cross Blue Shield of New Jersey and BlueCross BlueShield of South Carolina. These five BCBS plans provide coverage for an additional 12 million patients in the United States. EndoPredict is a second-generation, multigene test that is designed to predict disease recurrence in patients diagnosed with breast cancer.
“We are excited to see that payers are increasingly recognizing the level and quality of clinical evidence supporting the EndoPredict test for patients with breast cancer,” said Johnathan M. Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. “EndoPredict ‘markedly outperformed’ the first-generation test in a large, head-to-head study recently presented at the San Antonio Breast Cancer Symposium in December. We are confident that EndoPredict will provide improved health outcomes and value for both patients and payers.”
These coverage decisions follow a recent positive review by Evidence Street, which provides technical assessments of medical technologies for the Blue Cross Blue Shield Association. Affiliated plans of the Association insure one in three Americans. Evidence Street’s review found that the EndoPredict test results in a meaningful improvement in the net health outcomes in node-negative breast cancer patients.
In aggregate, payers in the United States now cover the EndoPredict test for more than 32 million patients. Myriad previously announced plans to launch EndoPredict in the United States in the first half of calendar year 2017. EndoPredict is marketed outside the United States and has been used to guide treatment selection in more than 13,000 patients.
EndoPredict is a second-generation, multigene test designed to predict disease recurrence in patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. In contrast to the first-generation multigene prognostic test (i.e., Oncotype Dx), 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: www.endopredictusa.com.
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 HRD, EndoPredict, Vectra, GeneSight 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 receiving coverage for the EndoPredict test from several health insurance providers in the Blue Cross Blue Shield affiliate network; the EndoPredict resulting in a meaningful improvement in the net health outcomes in node-negative breast cancer patients, consistent with the level of evidence used to support coverage of the first-generation test; the number of additional patient lives covered by these five BCBS plans in the United States; the number of patient lives now covered by payers in the United States for the EndoPredict test; EndoPredict testing providing improved health outcomes and value for both patients and payers; the Company’s plans to launch the EndoPredict test in the United States in the first half of calendar year 2017; 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, 2016, 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.
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