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New Studies Highlight Performance of Vectra® Test in Patients with Rheumatoid Arthritis Who Were Treated with Tofacitinib and Rituximab
Data Show Vectra Test Is Correlated with Treatment Response
SALT LAKE CITY, Oct. 19, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced new data from two studies of Vectra® that evaluated the test’s ability to track treatment response in patients with rheumatoid arthritis (RA). The studies were conducted by academic collaborators and will be presented at the American College of Rheumatology meeting in Chicago, IL. The key findings are that Vectra statistically significantly predicted response to tofacitinib and tracked response to rituximab.
“We are committed to advancing the knowledge of the Vectra test for rheumatologists and their patients with rheumatoid arthritis. This year we are highlighting two new studies that demonstrate the performance of Vectra in patients treated with Ritaximab and Tofacitinib,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Myriad Autoimmune. “The goal is to provide rheumatologists with objective molecular information that can enable better patient management.”
Vectra is the leading personalized medicine test for patients with RA, and it is used to assess changes in disease activity. In a recently presented analysis based on multiple studies, Vectra was shown to be three times more effective at predicting radiographic progression in patients with RA compared to other measures of disease activity.
The key data are summarized below. Please visit Myriad Autoimmune at Booth #321 to learn more about Vectra. Follow Myriad on Twitter via @MyriadGenetics and @Vectra and stay informed about conference news and updates by using the hashtag #ACR18.
Title: Baseline Power Doppler and MBDA Score Predicts 12 Week Disease Activity Response to Tofacitinib.
Presenter: Amir Razmjou, M.D., UCLA-David Geffen School of Medicine, Los Angeles, Calif.
Date: Sunday, Oct. 21, 2018, 9:00-11:00 a.m. CDT.
Abstract Number: 582.
This is the first study to evaluate whether baseline Vectra scores were predictive of clinical response in 25 patients with RA who were treated with tofacitinib. Vectra scores were assessed at baseline, 2 and 12 weeks. The results show that the Vectra score at baseline was a statistically significant predictor of treatment responses to tofacitinib at week 12 (p<0.01).
Title: The Multi-Biomarker Disease Activity Score Tracks Response to Rituximab Treatment in Rheumatoid Arthritis Patients.
Presenter: Nadia MT Roodenrijs, Ph.D. candidate, University Medical Center Utrecht, the Netherlands.
Date: Monday, Oct. 22, 2018, 9:00-11:00 a.m. CDT.
Abstract Number: 1500.
This is the first study to demonstrate that the Vectra score tracked disease activity in RA patients treated with rituximab and that change in the Vectra score reflected the degree of treatment response. The Vectra score was measured at baseline (n=57) and at 6 months (n=46). The results show that the improvement in the Vectra score after 6 months was statistically significant (p<0.01), reflecting response to treatment with rituximab.
“We are excited about these new findings which advance the knowledge on Vectra,” said Hitraya. “We’re committed to proving rheumatologists with valuable information about a patient’s disease activity that can help direct treatment strategies and improve patient outcomes.”
About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease that mainly attacks the body’s joints, leading to significant morbidity and financial burden. Approximately 60 percent of people with inadequately treated RA are unable to work 10 years after onset. The American College of Rheumatology estimates that RA affects 1.3 million people in the United States.
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 guides 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 web portal, VectraView. For more information on Vectra, please visit: www.vectrada.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 five strategic imperatives: build 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 Prelude 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 the Company’s two studies on Vectra® being featured at the American College of Rheumatology (ACR) meeting being held Oct. 19-24, 2018 in Chicago, IL; the key findings of the studies that Vectra statistically significantly predicted or track response to tofacitinib and rituximab; the Company’s ongoing commitment to proving rheumatologists with valuable information about a patient’s disease activity that can help direct treatment strategies and improve patient outcomes; 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, 2018, 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.