Myriad Announces the Launch of a New Radiographic Progression Prognostic Tool, Adding to Clinical Value of Vectra®
SALT LAKE CITY, July 28, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today that the company has launched a new enhancement that is now available on its Vectra® test report. The new test report provides an individualized estimate of a patient’s one-year risk of rapid radiographic progression (RP). The RP result in every report is personalized based on the patient’s age, gender and adiposity.
“We previously presented data demonstrating that Vectra is the best single predictor of joint damage. Inclusion of information on RP risk in the Vectra test report now gives clear insight into both the patient’s current rheumatoid arthritis (RA) inflammation and the future risk of joint damage,” said Mark S. Verratti, president of Myriad Neuroscience and Myriad Autoimmune. “With this new product enhancement, Vectra as a prognostic tool can help further guide medical management decisions for patients with RA.”
In a combined analysis of patients from three studies, 42 percent of patients thought to be in low or moderate disease activity assessed by a traditional disease activity measure were in high disease activity as measured by Vectra, and thus were at risk of irreversible joint damage within one year. Each patient will receive an individualized percentage risk prediction for radiographic progression within one year (see Example 1 below), helping physicians and patients make treatment decisions.
To view Example 1: The Vectra Score correlates to the risk of radiographic progression, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/1ed33a2f-4c29-4cbb-8b86-c12f819b9910
RA is an inflammatory autoimmune disease that attacks a patient’s joints and often affects other organ systems. RA is a contributing condition that leads to increased disability, significant morbidity, increased mortality and financial burden. Lost productivity associated with RA is substantial, with approximately 20-70 percent of individuals working at the time of their RA diagnosis were disabled after seven to 10 years. RA affects roughly more than one million people in the United States. The Vectra Score measures the concentrations of 12 serum biomarkers and an algorithm is applied to these biomarker concentrations to calculate a disease activity score on a scale of 1 to 100. Vectra Disease Activity Levels are as follows: Green = Low: 1 to 29, Orange = Moderate: 30 to 44, Red = High: 45 to 100. The risk of RP is shown as a function of Vectra Score. The definition of RP is a 1-year total Sharp score change of >5 units. Increased risk of RP means a greater chance of irreversible joint damage.
Three out of four rheumatologists have used Vectra and have ordered more than one million tests for their RA patients. The American College of Rheumatology (ACR) includes Multi-Biomarker Disease Activity Score (Vectra) as a disease activity measure that meets minimum standards for regular use for patients with rheumatoid arthritis. Those recommendations were published in the journal Arthritis Care & Research.
Vectra is a multi-biomarker molecular blood test that provides an objective and personalized measure of inflammatory disease activity in patients with rheumatoid arthritis. Vectra demonstrates unsurpassed ability to predict radiographic progression and can help guide medical management decisions to improve patient outcomes. Vectra testing is performed at a state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician five to seven days from shipping of the specimen. Physicians can receive test results by fax or the private provider web portal, VectraView™. For more information on Vectra, please visit: www.VectraScore.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, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore 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 launch of Radiographic Progression estimates on Vectra® test reports; 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: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; 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 decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); 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 most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, 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.
|Media Contact: Jared Maxwell||Investor Contact: Scott Gleason|
|(801) 505-5027||(801) 584-1143|