Healthcare Industry News: hereditary cancer
News Release - November 12, 2013
Myriad Genetics Launches myPath(TM) Melanoma Diagnostic TestTest Accurately Differentiates Malignant Melanoma From Benign Skin Lesions
SALT LAKE CITY, Nov. 12, 2013 -- (Healthcare Sales & Marketing Network) -- Myriad Genetics, Inc. (MYGN) today announced that it has launched Myriad myPath(TM) Melanoma, a new diagnostic test to effectively differentiate malignant melanoma from benign pigmented skin lesions.
The myPath Melanoma test has been extensively investigated in two independent clinical studies. Myriad recently presented its verification study results at the American Society of Dermatopathology annual meeting. These data showed that the myPath Melanoma test demonstrated over 90 percent accuracy in differentiating malignant melanoma from benign skin lesions in a variety of subtypes. Results of this study have recently been confirmed in an independent clinical validation study that will be presented at the American Academy of Dermatology in March 2014.
"Even with years of clinical experience, pathologists still have cases where a definitive diagnosis is uncertain. In these cases, patients and physicians face the difficult question of whether to treat the lesion as melanoma or risk not treating a potentially fatal cancer," said Mark C. Capone, president of Myriad Genetic Laboratories. "Myriad myPath Melanoma is designed for these difficult-to-diagnose cases and will provide healthcare providers with objective data that will improve the diagnosis of patients with suspicious skin lesions."
Myriad myPath Melanoma is being launched in a phased approach beginning with an early-access program called The melEval Program that will introduce the test to leading dermatopathologists across the country. myPath Melanoma will be sold through a dedicated specialty sales force from Myriad and has average selling price of $1,500. For more information, visit www.isthismelanoma.com.
Myriad myPath Melanoma is the third molecular diagnostic test launched by Myriad this fiscal year. In October, the Company launched Myriad myPlan(TM) Lung Cancer, a new prognostic test for patients diagnosed with early-stage lung cancer. In September, the Company launched Myriad myRisk(TM) hereditary cancer, a new multi-gene diagnostic test for eight major hereditary cancers including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.
Melanoma is the most serious type of skin cancer. According to the American Cancer Society statistics, about 76,000 new melanomas are diagnosed each year, and more than 9,000 people die from melanoma annually. Each year in the United States, there are approximately two million skin biopsies performed specifically for the diagnosis of melanoma. Approximately 14 percent or 280,000 biopsies are classified as indeterminate, which means the dermatopathologist cannot confidently determine whether the cells are benign or malignant.
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: www.myriad.com.
Myriad, the Myriad logo and Myriad myPath Melanoma, Myriad myPlan Lung Cancer, Myriad myRisk hereditary cancer, 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 Myriad myPath Melanoma being launched in a phased approach beginning with an early-access program to a select group of dermatopathologists, followed by a full commercial launch in calendar year 2014; Myriad myPath Melanoma being sold through a specialty sales force; Myriad myPath Melanoma being an important new molecular diagnostic test that can effectively differentiate malignant melanoma from benign pigmented skin 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 include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic 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; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic 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; risks related to increased competition and the development of new competing tests 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; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic 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 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.
Source: Myriad Genetics
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