SALT LAKE CITY, Utah, Nov. 7, 2014 - Myriad Genetics, Inc. (Nasdaq: MYGN) today presented results from a prospective clinical utility study of its Myriad myPath Melanoma test at the 2014 American Society of Dermatopathology (ASDP) annual meeting in Chicago, Ill. Myriad myPath Melanoma is a genetic test that differentiates malignant melanoma from benign skin lesions across all major melanoma subtypes. Key findings of this clinical utility study included a 43 percent reduction in indeterminate diagnoses and a 49 percent change in physicians' treatment recommendations for patients.
"These findings demonstrate the power of Myriad myPath Melanoma to improve patient care through more definitive diagnoses of skin lesions, particularly in these difficult-to-call cases," said Loren Clarke, M.D., vice president of Medical Affairs at Myriad Genetic Laboratories. "Importantly, the number of indeterminate cases was significantly reduced, which means less uncertainty for more patients and physicians, and may lead to less overtreatment in these cases."
The study evaluated the impact of the Myriad myPath Melanoma diagnostic test on dermatopathologists' diagnoses and intended treatment recommendations for 218 patients with pigmented skin lesions that were considered difficult to diagnose. The dermatopathologists recorded their diagnoses and treatment plans before and after receiving the myPath Melanoma test results. The changes in patient diagnoses are summarized in the table below.
|Pathology Diagnosis||Pre-Test (N=218)||Post-Test (N=218)||% Change|
The dermatopathologists also were asked how the Myriad myPath Melanoma test result would change their intended treatment recommendations for patients. Overall, changes in treatment recommendations were observed in 49.1 percent of difficult-to-diagnose cases. In 39.4 percent of patients receiving a benign test result, recommendations were downgraded to less invasive treatment. Conversely, in 45.8 percent of patients receiving a malignant test result, recommendations were upgraded to more invasive treatment.
"These data strongly support the integration of the Myriad myPath Melanoma test into clinical practice to personalize and improve patient care," said Clarke. "The Myriad myPath Melanoma test objectively answers a vital clinical question for physicians: Does my patient have malignant melanoma that requires aggressive intervention, or a harmless skin lesion that should be monitored?"
About Myriad myPath Melanoma
Myriad myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma 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 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 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 Lung Cancer, BRACAnalysis CDx, HRD, Vectra 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 myPath Melanoma clinical study data at the 2014 ASDP Annual Meeting; data showing that physicians would change their treatment plan for patients with melanoma based on myPath test results; the effectiveness of myPath testing to accurately differentiate malignant melanoma from benign lesions; 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 and uncertainties include, but are not limited to: the risk that sales and profit margins of our 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, including unexpected costs and delays; 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 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; 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 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 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 Annual Report on Form 10-K for the fiscal year ended June 30, 2014, 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.