SALT LAKE CITY, April 05, 2017 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that it has published the third clinical validation study and second clinical utility study for its myPath® Melanoma test, which completes the reimbursement dossier for the product. The Company also announced it will submit the reimbursement dossier to Medicare and private insurers three months earlier than expected. myPath Melanoma is an objective genetic test that measures 23 genes to help differentiate malignant melanoma from benign lesions.
“The pivotal results from these two studies join a number of additional publications, which is the culmination of five years of extensive scientific research and innovation,” said Vicki Fish, vice president, Dermatology Business Unit, Myriad Genetic Laboratories. “We believe that our reimbursement dossier is exceptionally strong, and we will work with health plans to ensure this test is widely accessible to the physicians and patients who need it.”
The third clinical validation titled “Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a Gene Expression Signature and Correlation to Clinical Outcomes” was published in the journal Cancer Epidemiology, Biomarkers & Prevention. The study assessed the performance of the myPath Melanoma test in an independent cohort of 182 patients with melanocytic lesions against clinically proven outcomes (99 primary melanomas with distant metastases and 83 benign moles). The median time to melanoma metastasis was 18 months and the median follow-up time for benign moles was 75 months. The results showed that the myPath Melanoma test had an overall diagnostic accuracy of 95 percent to effectively differentiate melanoma from benign lesions. These strong findings demonstrate that the myPath Melanoma test closely correlates with long-term clinical outcomes and adds valuable information to assist in the accurate diagnosis of melanoma.
The second clinical utility study titled “The Influence of a Gene Expression Signature on the Treatment of Diagnostically Challenging Melanocytic Lesions” was published in the journal Personalized Medicine. This study was designed to evaluate changes in real world patient management based upon the myPath Melanoma test result. Samples from 77 patients with suspicious skin lesions (i.e., melanocytic neoplasms) were tested using the myPath Melanoma test accompanied by pre-test documentation of the intended treatment recommendations. The actual treatment provided by dermatologists was then documented after testing. The results showed there was a 71 percent change in patient management from pre-test recommendations and an 81 percent reduction in biopsy site re-excisions for patients with a benign test result. Based on these findings, the myPath Melanoma test significantly influenced the physicians’ treatment of patients.
A list of the key analytic validation, clinical validation and clinical utilities studies that comprise the myPath Melanoma reimbursement dossier follows below.
Key Elements of myPath Melanoma Reimbursement Dossier
|Study||Key Result||Peer-Reviewed Publication|
|Clinical Validation 1 (n=437)||• >90 percent diagnostic accuracy||Journal of Cutaneous Pathology (2015)|
|Clinical Validation 2 (n=736)||• >91 percent diagnostic accuracy||Cancer (2016)|
|Clinical Validation 3 (n=182)||• >95 percent diagnostic accuracy||Cancer Epidemiology, Biomarkers & Prevention (2017)|
|Analytic Validation (n=544)||• Only 2.5 percent standard deviation of the score High dynamic range, precision, RNA yield||Biomarkers in Medicine (2015)|
|Clinical Utility 1 ( n=218)||• >50 percent increase in definitive diagnoses for cases that were originally diagnosed as indeterminate. |
• ~50 percent change in treatment recommendations for diagnostically challenging cases.
|Clinical Utility 2 (n=77)||• 71 percent change in patient management from pre-test recommendations|
• 81 percent reduction in excisions for patients with a benign test.
|Personalized Medicine (2017)|
|Health Economic||• 8.3 percent reduction in 10-year costs per patient.|
• Savings of $.067 per member per month.
|Journal of Medical Economics (2014).|
”Melanoma is one of the fastest growing cancers in the United States, and there is demand among physicians for an objective, high quality, clinically validated molecular diagnostic test to be used as an adjunct to conventional tools like the microscope,” said Loren Clarke, M.D., board-certified dermatopathologist and medical director, Dermatology, Myriad Genetic Laboratories. “We believe myPath Melanoma is one of the most studied and accurate molecular diagnostic tests ever developed. It has enormous potential to help save the lives of people with melanoma, spare people with benign moles from unneeded treatment and lower costs for our healthcare system.”
Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates about myPath Melanoma 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 87,000 Americans are expected to be diagnosed with Stage I-IV melanoma and another 75,000 will be diagnosed with melanoma in situ – totaling approximately 162,000 total diagnoses. Early and accurate diagnosis of melanoma is critical for long-term survival. For more information visit: www.mypathmelanoma.com/.
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, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight 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 relating to publication of the third clinical validation study and second clinical utility study for the myPath Melanoma test; the Company’s plans and timing to seek reimbursement from Medicare and private payers; the ability of the myPath Melanoma test to differentiate malignant melanoma from benign lesions with 95 percent diagnostic accuracy; the ability of the myPath Melanoma test to closely correlate with long-term clinical outcomes; the ability of the myPath Melanoma test to significantly influence physicians’ treatment of patients; 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 described or implied 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 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; 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 Assurex, Sividon and the Clinic; 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; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; 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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