Myriad Genetics Launches the EndoPredict® Test in the United States for Patients with Breast Cancer
SALT LAKE CITY, March 13, 2017 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that it has launched the EndoPredict® test in the United States for patients with ER+ HER2- early-stage breast cancer. EndoPredict is a second-generation test for assessing the 10-year risk of disease recurrence following surgery and for determining which patients can safely forgo adjuvant chemotherapy.
“Today’s launch strengthens our oncology product portfolio and represents a meaningful advancement in the treatment of patients with breast cancer,” said Lloyd Sanders, general manager, Oncology, Myriad Genetic Laboratories. “Along with our best-in-class tests for hereditary cancer and our companion diagnostics, the launch of EndoPredict underscores our commitment to pioneering science, personalized medicine and patient care.”
EndoPredict is supported by multiple prospective clinical studies and data from more than 3,500 patients with ER+ HER2- node negative and node positive early-stage breast cancer. The results of the clinical development program show that EndoPredict substantially outperforms the first generation breast cancer recurrence tests. EndoPredict was trained and validated using 10-year outcomes data and includes proliferation-related genes as well as hormone receptor-related genes, providing accurate assessment of early and late risk for recurrence and definitively classifies patients as low or high risk.
“Breast cancer is a complicated disease and there is a critical need for accurate breast cancer recurrence tests that help physicians determine which patients can safely forgo adjuvant chemotherapy,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. “The launch of EndoPredict is an important advancement for patients and doctors. By automatically incorporating clinical features and generating an individualized patient test result, EndoPredict identifies a larger subset of true low-risk patients who may safely forgo adjuvant chemotherapy."
EndoPredict already is included in medical guidelines including the American Society of Clinical Oncology (ASCO), European Society of Medical Oncology (ESMO) and the St. Gallen International Breast Conference. Additionally, the Integrated Oncology Network (ION) named EndoPredict as its preferred breast cancer recurrence test. Myriad is working with payers to making sure EndoPredict is a widely accessible to patients. So far, the test has received positive coverage decisions from 19 payers, bringing total coverage to over 70 million patients in the United States.
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Clinical Data Supporting the Launch
|Name of Trial||# of
| Breast Cancer
|Nodal Status|| 10-Year Distant
for Low Risk
About Breast Cancer
Breast cancer is the second leading cause of mortality among women. A woman living in the United States has a 12.3 percent, or a 1 in 8, lifetime risk of being diagnosed with breast cancer. In 2017, invasive breast cancer will be diagnosed in more than 246,660 women.
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 develop personalized treatment plans for their patients. EndoPredict has been validated in approximately 3,500 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. EndoPredict was trained and validated using 10-year outcomes data and includes proliferation-related genes as well as hormone receptor-related genes providing an accurate assessment of early and late risk for recurrence. Therefore, 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 the launch of the EndoPredict test in the United States for patients with ER+ HER2- early-stage breast cancer; the ability of EndoPredict to assess the 10-year risk of disease recurrence following surgery; the ability of EndoPredict to identify a larger subset of true low-risk patients who may safely forgo adjuvant chemotherapy; EndoPredict providing more accurate 10-year risk for patients diagnosed with ER+ HER2- early-stage breast cancer; the ability of EndoPredict to determine which patients can safely forgo adjuvant chemotherapy; EndoPredict substantially outperforming the first generation breast cancer recurrence tests; the extent of positive coverage decisions for EndoPredict and the Company’s work with payers to make sure EndoPredict is widely accessible to patients; therapy decisions backed by EndoPredict conferring a high level of diagnostic safety; 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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