Myriad Genetics to Highlight New Clinical Outcomes Data on myPath(R) Melanoma at the American Society of Dermatopathology Annual Meeting
SALT LAKE CITY, Oct. 8, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that new clinical outcomes and clinical utility data for myPath® Melanoma will be featured at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif. The findings add to the growing body of knowledge for myPath Melanoma and will support the Company's clinical reimbursement dossier for the product.
"The accurate diagnosis of melanoma can be challenging based on histologic findings alone and there are potentially severe consequences of a misdiagnosis, including the under-treatment or overtreatment of patients," said Loren Clarke, M.D., vice president, Medical Affairs for Dermatology, Myriad Genetic Laboratories. "Our studies show that myPath Melanoma accurately differentiates malignant melanoma from benign skin lesions and helps physicians deliver a more objective and confident diagnosis for their patients."
A list of the myPath Melanoma presentations at ASDP (#ASDP2015) follows.
Title: Correlation of myPath Melanoma gene expression score with clinical outcome on a series of melanocytic lesions.
Date: Saturday, Oct. 10, 2015: 3:00 p.m. PT.
Location: Hilton Union Square, Continental 4-6.
Eugen Minca, M.D., department of Pathology, Cleveland Clinic, will present a study that correlates myPath Melanoma test results with clinical outcomes data (e.g., recurrence, sentinel lymph node metastases and distant metastases) from 127 patients with melanocytic lesions. Of these cases, 65 lesions were melanomas and 62 were benign lesions, according to the pathology diagnosis. The myPath Melanoma test scores were reviewed in conjunction with the diagnosis and clinical outcome. Of the 65 melanomas, 14 developed metastases and 51 had no adverse events after 47 months of follow up and myPath Melanoma diagnosed malignancy in all 14 cases with adverse outcomes, which represents a 100 percent sensitivity rate in these metastatic cases. There were no adverse events associated with the 62 benign lesions after an average follow up of 30 months. Of these, the myPath Melanoma test produced a benign score in 48 cases, an indeterminate score in seven cases and a malignant score in seven cases. Importantly, after myPath testing and upon expert histologic review, three of the seven cases with a malignant score were reclassified as melanomas. This is the first study with clinical outcome data and supports previous validation studies demonstrating that the myPath Melanoma test provides additional insight into difficult-to-diagnose lesions, supporting its use as an ancillary diagnostic test.
Title: A retrospective study of the influence of a gene expression signature on the treatment of melanocytic tumors.
Date: Thursday, Oct. 8 from 1:00 p.m. PT to Oct. 11 at 11:00 a.m. PT.
Location: Golden Gate, Ballroom.
In this study, 632 difficult-to-diagnose melanocytic lesions were analyzed using the myPath Melanoma diagnostic test. Retrospective chart reviews were conducted for 315 of the cases to document the actual treatment carried out for each patient. Of these, 214 patients received a benign myPath Melanoma test result, 92 received a malignant result and nine received an indeterminate result. The percentage change was measured from the treatment recommendations of the expert dermatopathologists to the actual treatment provided by dermatologists. The results show that excisions were reduced by 33.1 percent in patients who received a benign myPath Melanoma test result. Conversely, the use of additional treatment, such as surgery, increased by 36.2 percent in patients who received a malignant myPath Melanoma test result. These data support the integration of the myPath Melanoma test into medical practice to improve patient care by allowing more definitive diagnoses by dermatopathologists and optimized treatment decisions by dermatologists.
About myPath® Melanoma
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 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: www.mypath.myriad.com and www.mypathmelanoma.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, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra 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 related to data being presented at the American Society of Dermatopathology (ASDP) 52nd meeting being held Oct. 8 to 11, 2015 in San Francisco, Calif.; the ability of myPath Melanoma to differentiate malignant melanoma from benign skin lesions and help physicians deliver a more objective and confident diagnosis for their patients; the ability of the myPath Melanoma test to demonstrate 100 percent sensitivity and concordance with the clinical outcome in metastatic melanomas and provide insight to difficult-to-diagnose lesions; the integration of the myPath Melanoma test into medical practice to improve patient care by allowing more definitive diagnoses by dermatopathologists and optimized treatment decisions by dermatologists; 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 molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in 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 and our healthcare clinic; 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 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 most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2015, 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. 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.
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