SALT LAKE CITY, Dec. 27, 2016 (GLOBE NEWSWIRE) -- Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN ), today announced that new data on the use of Vectra ® DA test to predict treatment response in patients with rheumatoid arthritis (RA) published online in the journal Arthritis & Rheumatology . 1
“This study highlights the clinical utility of the Vectra DA test to help predict treatment response to biologic and non-biologic therapies in methotrexate incomplete responders,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience. “These results showed that Vectra DA performed better than clinical and single inflammatory biomarkers at predicting response to non-biological therapy intensification versus anti-TNF (infliximab) therapy. This publication adds to the growing body of data on the use of the Vectra DA test to help individualize treatment plans and improve health outcomes for patients with RA.”
The objective of this study was to evaluate whether the Vectra DA score could be used to predict the optimal choice of second-line treatment for 157 patients with RA who were methotrexate (MTX) incomplete responders (MTX-IR). The findings demonstrated that, in patients with early RA and incomplete response to MTX, the Vectra DA test predicted those who were more likely to respond to treatment with triple therapy versus anti-TNF (infliximab). Specifically, patients with a lower Vectra DA score at three months following treatment with MTX monotherapy were more likely to respond to triple therapy versus MTX+infliximab (88 percent vs. 18 percent, respectively; p=0.006). In contrast, patients who had a high Vectra DA score at three months were more likely to respond to anti-TNF therapy (35 percent vs. 58 percent, respectively; p=0.040). Importantly, the Vectra DA score at three months was a better independent predictor of treatment response at Year 1 than clinical or single inflammatory biomarkers (CRP, ESR) or DAS28). These results demonstrate that Vectra DA could be used to guide biologic or non-biologic treatment decisions for patients with early RA who do not respond to MTX monotherapy in the first three months.
The Vectra DA test is the first and only multi-biomarker blood test validated to measure disease activity in patients with RA. Vectra DA has been evaluated in more than 20 studies with more than 3,000 patients. The value that Vectra DA offers rheumatologists is demonstrated by the fact that 3 out of 4 rheumatologists have ordered Vectra DA for ~300,000 patients in the United States.
Recently, Vectra DA was included in guidelines published by United Rheumatology, and will be evaluated for inclusion in the American College of Rheumatology (ACR) guidelines.
1 Hambardzumyan K, Saevarsdottir S, Forslind K, et al. A multibiomarker disease activity score and the choice of second-line therapy in early rheumatoid arthritis after methotrexate failure. Arthritis Rheumatol . December 19, 2016. Accessed online at: www.ncbi.nlm.nih.gov/pubmed/27992691 .
About Vectra ® DA Vectra DA is the only multi-biomarker blood test for rheumatoid arthritis (RA) disease activity that integrates the concentrations of 12 serum proteins associated with RA disease activity into a single objective score, on a scale of 1 to 100, to help physicians make more informed treatment decisions. Vectra DA testing is performed at the Crescendo Bioscience state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility. Test results are reported to the physician 5 to 7 days from shipping of the specimen to Crescendo Bioscience. Physicians can receive test results via standard mail, by fax or via the private web portal, VectraView. For more information on Vectra DA, please visit: www.Vectra-DA.com .
About Crescendo Bioscience Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc., is a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other autoimmune diseases, located in South San Francisco, Calif. Crescendo Bioscience develops quantitative, objective, reproducible blood tests to provide rheumatologists with deeper clinical insight to help enable more effective management of patients with autoimmune and inflammatory diseases. For more information, please visit the company website at www.CrescendoBio.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, BRAC Analysis , Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra 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 the Vectra DA data published in the journal Arthritis & Rheumatology ; the ability of Vectra DA to predict or assess treatment response in patients with rheumatoid arthritis; and the Company’s strategic directives under the captions “About Crescendo Bioscience” and “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 described or implied 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 pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the 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 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, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; 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 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 Annual report on Form 10-K for the fiscal year ended June 30, 2016, 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.
Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.com
