Data from >800 Patients Shows that a High Vectra DA Score is Associated with an Increased Risk of Joint Damage and Is More Predictive than Conventional Measures of RA
SALT LAKE CITY, June 15, 2017 (GLOBE NEWSWIRE) — Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ:MYGN), today announced that new data from a meta-analysis of clinical studies and a registry demonstrating the ability of the Vectra® DA test to predict joint damage were presented at the European League Against Rheumatism (EULAR) meeting in Madrid, Spain.
The key finding is that high Vectra DA score is associated with significantly increased risk of joint damage progression in a variety of patients with rheumatoid arthritis (RA), including those treated with disease-modifying antirheumatic drugs (DMARDs), tumor necrosis factor-alpha inhibitors (TNFi) and abatacept.
“We are very excited to present a meta-analysis data from over 800 patients tested with the Vectra DA test, which shows our ongoing commitment to collaborate with academic researchers to advance the knowledge of Vectra DA and its utility in the management of rheumatoid arthritis,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience. “Importantly, this analysis confirms the consistency and robustness of the previous findings. This new information advances the understanding of the role of molecule biomarkers in RA and can help to facilitate the discussion on the role of biomarkers in RA treatment guidance.”
The data are highlighted below and the abstract is available online at: www.congress.eular.org/abstract_archive.cfm. Follow Vectra DA on Twitter via @VectraDA and Myriad via @MyriadGenetics to stay informed about meeting news and updates by using the hashtag #EULAR2017.
Vectra DA Poster Presentation
Title: High multi-biomarker disease activity score is associated with high risk of radiographic progression in six studies.
Presenter: Eric Sasso, M.D., Crescendo Bioscience.
Date: Thursday, June 15, 2017, 11:45—1:30 p.m. CEST.
Location: Poster THU0091.
The analysis evaluated data from six cohorts to establish the relationship between the Vectra DA score and risk for radiographic progression (RP). The studies included had more than 800 patients with rheumatoid arthritis (RA) who received conventional DMARDs alone or with adalimumab, infliximab or abatacept. Overall rates of RP were 10 to 26 percent. In each study, RP was most frequent among patients with a high vs. low/moderate Vectra DA score (>44 vs. ≤44). Patients with high Vectra DA scores, were 3.6 to 9.5 times as likely as patients with low Vectra scores to develop RP (P=0.002 to <0.0001). The data from this study are summarized in Table 1.
TABLE 1: Association between radiographic progression and high Vectra DA score (>44)
|Study||N||Overall (%) RP||Relative Risk||P-Value|
|Meta-Analysis (Leiden + OPERA + SWEFOT Year 1||5.1||<0.0001|
|AMPLE 5Year 1
|AMPLE5 Year 1
A meta-analysis of the Leiden, SWEFOT Year 1 and OPERA Year 1 studies, showed that patients with a high Vectra DA score were 5.1 times as likely to develop RP (P<0.0001). In comparison, patients were 1.4 times as likely to develop RP as measured by DAS28-CRP (P=0.23) and 1.6 times as likely as measured by CRP alone (P=0.01), underscoring the superior predictive power of Vectra DA compared with conventional assays (Graph 1).
1 LEIDEN: van der Helm-van Mil et al. Rheumatology (Oxford). 2013;53:839—846.
2 OPERA: Brahe et al. Arthritis Rheumatol. ACR 2016 Abstract 2520.
3 SWEFOT Year 1: Hambardzumyan K, et al. Ann Rheum Dis. 2015;74:1102—9.
4 SWEFOT Year 2: Hambardzumyan K et al. RMD Open. 2016 Mar 1;2(1):e000197.
5 Curtis et al. Arthritis Rheumatol. 2016 Nov 3. doi: 10.1002/art.39981 and Fleischmann et al. Arthritis Rheumatol. 2016 Dec 19. DOI: 10.1002/art.40021.
Graph 1: Meta-analysis Showing Relative Risk of Radiographic Progression for Patients with High vs. Low Scores for Vectra DA, DAS28-CRP or CRP.
The graph is available for download here: http://www.globenewswire.com/NewsRoom/AttachmentNg/dbb9131d-1400-4d88-b0a6-0499c3e42ddc
“In this meta-analysis, the Vectra DA test has demonstrated the superior ability to predict joint damage compared with traditional measures such as DAS28-CRP or CRP, making Vectra DA an important tool in the management of patients with RA,” said Hitraya. “Importantly, Vectra DA also demonstrated clinical value by identifying patients with little or no risk of RP. We believe combining the Vectra DA score with conventional clinical measures will enable physicians to individualize treatment plans for their patients, improve outcomes and reduce the burden of future healthcare costs associated with this disabling disease.”
The efficacy of Vectra DA has been proven in more than 35 studies with more than 3,000 patients. The clinical utility for Vectra DA has been widely recognized as three out of four rheumatologists have used Vectra DA and have ordered it for more than 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. Additionally, Creaky Joints, a leading advocacy group for patients with RA added Vectra DA to its professional guidelines, which underscores the importance of Vectra DA to the patient community.
About Vectra® DA
Vectra DA is the only multi-biomarker blood test for rheumatoid arthritis 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 predict radiographic progression and 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, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad 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 relating to the Vectra DA data to be presented at the 2017 Annual European Congress of Rheumatology (EULAR) Annual Meeting, June 14-17, 2017 in Madrid; the ability of Vectra® DA to predict permanent joint damage; the Company’s ongoing commitment to collaborate with academic researchers to advance the treatment of rheumatoid arthritis; any potential review of medical guidelines for rheumatoid arthritis in light of the advances being made in molecular biomarkers for RA; the potential clinical utility of the Vectra DA study results and findings for guiding treatment decisions in patients with RA; the combination of the Vectra DA score with conventional clinical measures enabling physicians to individualize treatment plans for their patients, improve outcomes and reduce the burden of future healthcare costs associated with RA; 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 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; 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, 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. 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.