Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced the publication of an important clinical study regarding its Vectra® test in Current Medical Research & Opinion.
SALT LAKE CITY, Feb. 22, 2019 –Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced the publication of an important clinical study regarding its Vectra® test in Current Medical Research & Opinion. The key finding is that the Vectra test (MBDA) was nearly three times better at predicting radiographic progression (i.e., new joint damage) than DAS28-CRP or CRP in people with rheumatoid arthritis (RA).
This study evaluated data from five cohorts in four studies to establish the relationship between the Vectra score and risk for radiographic progression (RP). The analysis included data from 929 patients with RA who received conventional DMARDs alone or with adalimumab, infliximab or abatacept. In every cohort, RP was most frequent among patients with a high Vectra score (>44) compared with patients with a low/moderate Vectra score (≤44). In addition, the study showed that patients with high Vectra scores were 4.6 times as likely as patients with low/moderate Vectra scores to develop RP (p<0.001) and was three times more predictive than traditional disease activity measures of DAS28-CRP or CRP (Figure 1).
“These findings suggest that the Vectra test is the best single method for identifying patients at risk of joint damage. When combined with a physician’s clinical assessment, the molecular information provided by Vectra can be used to modify treatments appropriately to avoid irreversible joint damage for their patients,” said Elena Hitraya, M.D., Ph.D., rheumatologist and chief medical officer at Myriad Autoimmune. “The consistency of data from multiple studies on the ability of Vectra to predict RP, compared to traditional measures of disease activity, provides strong evidence that Vectra represents an advance in patient care.”
Figure 1: Vectra Is ~3X More Effective as a Predictor of RP than DAS28-CRP or CRP
- LEIDEN: van der Helm-van Mil et al. Rheumatology (Oxford). 2013; 53:839-846.
- OPERA: Brahe et al. Arthritis Rheumatol. ACR 2016. Abstract 2520.
- SWEFOT Year1: Hambardzumyan k, et al. Ann Rheum Dis. 2015; 74:1102-9.
Vectra is the leading personalized medicine test for patients with RA. The clinical performance of Vectra has been demonstrated in 35 published studies in more than 3,000 patients. Three out of four rheumatologists have used Vectra and have ordered it for more than 425,000 of their patients. Vectra has been included in clinical guidelines used by United Rheumatology and Bendcare and is being considered for inclusion in the American College of Rheumatology guidelines.
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.
About Vectra
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 helps 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 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. Follow Myriad on Twitter via @MyriadGenetics.
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 related to the Vectra test significantly outperforming DAS28-CRP and CRP; the Vectra test being the best predictor of joint damage in patients with rheumatoid arthritis; the information provided by Vectra being used to modify treatments and avoid irreversible joint damage for their patients; Vectra representing an advance in patient care; potential inclusion of Vectra in the American College of Rheumatology guidelines; 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.
