The Myriad myPath® Melanoma Test Effectively Diagnosed Patients in the Largest Outcomes-Based Study for a Melanoma Diagnostic
SALT LAKE CITY, Oct. 27, 2016 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced it will present two new studies at the American Society of Dermatopathology (ASDP) annual meeting being held Oct. 27-30, 2016 in Chicago, Ill. The research being presented validates the accuracy of Myriad myPath® Melanoma in differentiating benign skin nevi from malignant melanoma.
"We are presenting landmark data from the largest outcomes-based study ever performed with a melanoma diagnostic," said Loren Clarke, M.D., medical director, Dermatology, Myriad Genetic Laboratories. "The myPath Melanoma test performed very well and identified patients with melanoma versus benign skin lesions with greater than 95 percent diagnostic accuracy, which is exceptional in molecular diagnostics for cancer, particularly given the extreme heterogeneity of melanoma."
"Pigmented or suspect skin lesions are difficult to diagnose in approximately 15 percent of cases," said Sancy Leachman, M.D., Ph.D., chair of the Department of Dermatology in the Oregon Health & Science University School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute. "A highly accurate biomarker like the myPath Melanoma test should help dermatologists augment their diagnosis of melanoma, improve patient care and lower healthcare costs."
Below are the featured presentations at ASDP (#ASDP2016).
Title: Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a Gene Expression Signature and Correlation to Clinical Outcome.
Presenter: Jennifer Ko.
Date: Friday, Oct. 28, 2016: 4:15 — 5:00 p.m. and Saturday, Oct. 29, 2016 10:00 — 10:45 a.m. CT.
In this study, research collaborators from the Cleveland Clinic, Stanford University and Nottingham University assessed the clinical accuracy (sensitivity and specificity) of the myPath Melanoma test against clinical outcomes in 182 patients with skin lesions (99 melanomas and 83 nevi) with more than 5 years of follow up. The results show that the myPath Melanoma test accurately differentiated benign lesions from melanoma with a sensitivity of 93.8 percent and a specificity of 96.2 percent when compared to known clinical outcomes. The diagnostic accuracy of the myPath Melanoma test was high even in a subset of difficult-to-diagnose cases and, in combination with two previous validation studies, the findings support its use as an adjunct method for the early and accurate diagnosis of melanoma.
Title: Gene Expression Signature as an Ancillary Method in the Diagnosis of Desmoplastic Melanoma.
Presenter: Loren Clarke.
Date: Sunday, Oct. 30, 2016: 8:20 — 8:30 a.m. CT.
The objective of this study was to assess the accuracy of the myPath Melanoma test in the differentiation of desmoplastic melanoma (DM) from benign skin lesions. These lesions represent approximately one percent of melanomas, but are known to be very difficult to diagnose. The analysis included samples from 20 patients with DM and 27 from patients with benign moles (nevi). The results showed that the myPath Melanoma test was positive in 15 of the 20 known melanomas, negative in four and indeterminate in one. The myPath score was negative in 24 of the benign nevi and indeterminate in three. Based on these findings, the myPath Melanoma test demonstrated approximately 80 percent diagnostic accuracy in this very difficult-to-diagnose subtype.
For more information about the meeting, please visit the ASDP website at https://www.asdp.org/annual-meeting/home/. Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.
Melanoma is one of the fastest growing cancers in the United States and can strike people of all ages, races and skin types. With a one-in-50 lifetime risk of developing melanoma, nearly 76,000 Americans are expected to be diagnosed with Stage I-IV melanoma and another 68,000 will be diagnosed with melanoma in situ — totaling approximately 144,000 total diagnoses. Early and accurate diagnosis of melanoma is critical for long-term survival. For more information visit: www.mypathmelanoma.com/ and www.myriadpro.com/melanoma.
About Myriad myPath® Melanoma
Myriad myPath Melanoma is a clinically validated test to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. The test measures the expression of 23 genes and accurately distinguishes melanoma from benign nevi.
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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra, Prolaris and GeneSight 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 Company presenting two new studies at the American Society of Dermatopathology Annual Meeting being held Oct. 27-30, 2016 in Chicago, Ill.; the accuracy and effectiveness of Myriad myPath Melanoma testing in differentiating benign skin nevi from malignant melanoma; and the Company's strategic directives under the captions "About Myriad myPath Melanoma" and "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 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 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 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 a healthcare clinic in Germany and Sividon Diagnostic and our planned acquisition of Assurex Health; risks related to our projections about our business, results of operations and financial condition; risks related to 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 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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