SALT LAKE CITY, Utah, Sept. 9, 2014 - Myriad Genetics, Inc. (Nasdaq: MYGN) today presented results from a pivotal clinical utility study of the Myriad myPath™ Melanoma test at the 2014 College of American Pathologists (CAP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a novel diagnostic test that differentiates malignant melanoma from benign skin lesions with greater than 90 percent accuracy and helps physicians deliver a more objective and confident diagnosis for patients.
This study evaluated the impact of the myPath Melanoma diagnostic test on expert dermatopathologists' diagnoses and treatment recommendations for patients. The analysis included 687 cases of pigmented skin lesions submitted by 42 leading dermatopathologists in the United States. These melanoma experts were asked to document their diagnosis, level of confidence, any further testing and recommendations for treatment both before and after receiving the myPath test results.
The results show that when the myPath Melanoma test score was provided to the dermatopathologists, they revised their treatment recommendations in 35 percent of cases. Additionally, the myPath test score led to a 76 percent reduction in "indeterminate" diagnoses. These data strongly support the integration of myPath Melanoma into clinical practice to improve the diagnosis of melanoma and enhance patient care.
"This clinical utility study demonstrates how the myPath Melanoma test can be successfully incorporated into clinical care to improve the treatment of malignant melanoma," said Loren Clarke, M.D., vice president of Medical Affairs at Myriad Genetic Laboratories. "Myriad myPath Melanoma provides objective information to answer an important clinical question: Does my patient have a melanoma that requires surgery or medical intervention or is the lesion a harmless mole that needs to be watched?"
About Myriad myPath Melanoma Testing
The Myriad myPath Melanoma test is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. The Myriad myPath Melanoma test is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method - information that can help physicians deliver a more confident diagnosis.
Melanoma is the most serious type of skin cancer. According to the American Cancer Society, about 76,000 new melanomas are diagnosed each year and more than 9,000 people die from the disease annually. Each year in the United States, there are approximately 1.5 million skin biopsies performed specifically for the diagnosis of melanoma, and approximately 14 percent or 210,000 biopsies are classified as indeterminate, meaning that the dermatopathologist cannot confidently determine whether the cells are benign or malignant. For more information visit: http://www.
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 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: http://www.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, HRD, Vectra DA and Prolaris 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 presentation of the Myriad myPath Melanoma test clinical study data at the 2014 CAP Annual Meeting; the effectiveness of Myriad myPath testing to accurately differentiate malignant melanoma from benign lesions and help physicians deliver a more objective and confident diagnosis; the Company's belief that the Myriad myPath Melanoma test represents a significant advancement in the prompt and accurate diagnosis of potentially fatal melanoma; the clinical use of the Myriad myPath Melanoma test as an adjunct to standard pathology techniques in the evaluation of pigmented skin lesions, particularly in difficult-to-classify cases; the Company's belief that the Myriad myPath Melanoma test will substantially improve the standard of care for patients with melanoma; 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: 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 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; 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 we may not be successful in transitioning from our existing product portfolio to our new products, such as our myRisk Hereditary Cancer test, which represents the next generation of our existing hereditary cancer franchise; the risk that we may not be able to generate sufficient revenue from our existing tests and our new tests or develop new tests; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; 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 increased competition and the development of new competing tests and services; 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; and other factors discussed under the heading "Risk Factors" contained in Item 1A in 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.