Healthcare Industry News: Hereditary Cancer test
News Release - September 5, 2013
Myriad Genetics Launches myRisk(TM) Hereditary Cancer PanelEarly Access Program Underway With Select Healthcare Providers
SALT LAKE CITY, Sept. 5, 2013 -- (Healthcare Sales & Marketing Network) -- Myriad Genetics, Inc. (MYGN) announced today that it has launched myRisk Hereditary Cancer, a new multi-gene diagnostic test that will provide increased sensitivity by analyzing 25 genes associated with eight major cancers including: breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.
"We are excited to launch myRisk Hereditary Cancer, which is a significant scientific advancement in Hereditary Cancer testing for a range of clinically-actionable cancers," said Mark Capone, president of Myriad Genetics Laboratories. "myRisk Hereditary Cancer will improve the quality of patient care by empowering healthcare providers with knowledge about their patients' risk of hereditary cancer and the appropriate medical management options available based on that risk."
myRisk Hereditary Cancer is being launched in a phased approach beginning with an early-access, clinical-experience program to a limited number of medical and scientific thought leaders followed by an expanded access program later in the year. The Company will present extensive clinical validity data for myRisk Hereditary Cancer at The Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA) annual meeting in October and the San Antonio Breast Cancer Symposium in December.
The new myRisk Hereditary Cancer test represents the next generation of Hereditary Cancer testing and will provide healthcare providers with clear and actionable information to improve patient care, regardless of whether the patient receives a positive or negative test result. Each test report will include a genetic test result, a clinical risk and healthcare management tool based on professional society guidelines.
"Myriad is taking a stepwise, careful approach to responsibly gather clinical experience with the myRisk Hereditary Cancer test before fully launching this potentially revolutionary new diagnostic test for hereditary cancer," said Lee S. Schwartzberg, M.D., chief, Division of Hematology and Oncology at the University of Tennessee Health Science Center. "Myriad's unparalleled experience bolstered by extensive clinical research provides the reassurance healthcare providers require to utilize new methods of Hereditary Cancer testing. Also, the breadth of Myriad's new test report should empower medical professionals with the right information to facilitate better education and counselling for their patients."
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo and BRACAnalysis, myRisk, myRisk Hereditary Cancer, and Myriad Practice Advisor are trademarks or registered trademarks of Myriad Genetics, Inc. 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 timing, scope and success of the initial and follow-on expanded access launch of myRisk Hereditary Cancer, the Company's new multi-gene diagnostic test to provide increased sensitivity by analyzing 25 genes associated with eight major cancers; the ability of myRisk Hereditary Cancer to improve the quality of patient care by empowering healthcare providers with knowledge about their patients' risk of hereditary cancer and the appropriate medical management options available based on that risk; the presentation of extensive clinical validity data for myRisk Hereditary Cancer at The Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA) annual meeting in October and the San Antonio Breast Cancer Symposium in December; the actionable information resulting from myRisk Hereditary Cancer to improve patient care, regardless of whether the patient receives a positive or negative test result; the information provided in each test report, including a genetic test result, a personalized cancer risk, and healthcare management tool based on professional society guidelines; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present 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 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 companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic 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; risks related to increased competition and the development of new competing tests 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; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic 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; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K 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.
Source: Myriad Genetics
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