New Studies Demonstrate the Predictive Value of the Vectra® Test in People Diagnosed with Rheumatoid Arthritis
Vectra Test Predicts Radiographic Progression and CV Risks Associated with Inflammation
SALT LAKE CITY, Nov. 09, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in precision medicine, announced that its Myriad Autoimmune business unit will present new data on the Vectra test at the 2019 ACR/ARP Annual Meeting being held Nov. 8-13, 2019 in Atlanta, GA. The key findings are that the Vectra test predicts the risk of radiographic progression (RP) within one year, and the Vectra score, in combination with other clinical measures, predicts the risk of a cardiovascular (CV) event in people with rheumatoid arthritis (RA).
“A hallmark feature of rheumatoid arthritis is inflammation, which increases the risk of joint damage, cardiovascular disease and other comorbidities,” said Elena Hitraya, M.D., Ph.D., rheumatologist and chief medical officer at Myriad Autoimmune. “The data being presented by our academic collaborators at ACR show that the Vectra test accurately measures inflammation and can help predict patients’ risk of adverse health outcomes, enabling clinicians to tailor precision treatment plans to achieve better outcomes.”
Title: Predicting Risk of Radiographic Progression for Patients with Rheumatoid Arthritis.
Presenter: Jeff Curtis, M.D., M.S., MPH, University of Alabama at Birmingham.
Date: Sunday, Nov. 10, 2019. 9:00-11:00 a.m.
Location: Poster 466.
This study evaluated the ability of the Vectra test to predict patients’ “individual percentage risk” of RP within one year. The analysis included combined data from 973 patients in four cohorts. The results demonstrate that the adjusted Vectra score was a superior predictor of RP within one year compared to DAS28-CRP, CRP, CDAI and swollen joint count. Additionally, the risk of permanent joint damage increased continuously with the adjusted Vectra score, meaning patients with a low adjusted Vectra score had a one to three percent risk of RP in one year, while patients with a moderate-to-high score had between seven and 47 percent risk (Graph 1). Based on these new data, the company is working to enhance the Vectra test report to provide patients with their “individual risk” of radiographic progression in one year.
To view Graph 1: Vectra Predicts Risk of Radiographic Progression in 1 Year, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/514919cd-81ca-4084-81df-682fedc1784b
“Too often people with RA are over- or under-treated because it is difficult for clinicians to accurately measure inflammation and determine the long-term prognosis of RA patients. As a result, some people are at increased risk of rapid radiographic progression,” said Jeff Curtis, M.D., M.S., MPH, lead investigator, rheumatologist and Professor of medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham. “It is critical that clinicians have reliable information when making treatment decisions. Our study demonstrated that the Vectra score was the strongest predictor of radiographic progression, which may help inform treatment plans and prevent future joint damage.”
Title: Derivation and Validation of a Biomarker-Based Cardiovascular Risk Prediction Score in Rheumatoid Arthritis.
Presenter: Jeff Curtis, M.D., M.S., MPH; University of Alabama at Birmingham.
Date: Tuesday, Nov. 12, 2019. 9:00-11:00 a.m.
Location: Poster 2350.
This study evaluated 30,751 Medicare patients with RA to develop and validate the Vectra CVD score, which predicts risk for a first cardiovascular (CV) event by combining data from Vectra and clinical measures. The primary CV outcome was a composite of three types of CV events – heart attack, stroke, and CV death – occurring within 3 years from testing. When the performance of the Vectra CVD score was compared to four other CV prediction models, the Vectra CVD score was a significant predictor of CV risk and was superior to all four other models. Importantly, when risk scores were converted to 3-year percentage risk for having a CV event, approximately 80 percent of patients were found to have a moderate or high risk of a CV event over 3 years, based on risk categories analogous to those of the American College of Cardiology/American Heart Association 2018 guidelines (Graph 2).
To view Graph 2: Vectra Predicts Risk of Cardiovascular Events in Patients with RA, please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/c902b4ec-a3c8-439f-9557-0a9b05631a1f
“People with rheumatoid arthritis have almost double the risk of heart attack, stroke and atherosclerosis. Traditional CV risk factors alone do not fully explain the increased rates of CV events in RA, and inflammation is a missing component that is measured by the Vectra test,” said Dr. Curtis. “In this study, the Vectra CVD score effectively predicted CV risk in people with RA. We believe the Vectra CVD score may assist clinicians to more quickly identify patients at high risk for CV events and target interventions that can be potentially life-saving.”
The company plans to publish these new data in peer reviewed medical journal and make the Vectra CVD score available to clinicians in fiscal year 2020. Please visit Myriad Autoimmune at booth #1419 to learn more about Vectra. Follow Myriad on Twitter via @myriadgenetics and follow meeting news by using the hashtag #ACR19.
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 provides unsurpassed ability to predict radiographic progression and can help guide medical management decisions with the goal of improving 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 web portal, VectraView. For more information on Vectra, please visit: www.vectrascore.com.
About Myriad Genetics
Myriad Genetics Inc. is a leading precision 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 five critical success factors: building upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. 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, riskScore, Prolaris, Foresight and Prequel 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 new data on the Vectra test at the 2019 ACR Annual Meeting; the Vectra test enabling clinicians to tailor precision treatment plans to achieve better outcomes; the Vectra score helping inform treatment plans and prevent future joint damage; the Vectra CVD score assisting clinicians to more quickly identify patients at high risk for CV events and target interventions that can be potentially life-saving; publishing these new data in peer reviewed medical journal; making the Vectra CVD score available to clinicians in fiscal year 2020; 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; 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.
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