Crescendo Bioscience Announces that New Studies with Vectra® DA Data Will Be Presented at the American College of Rheumatology 2015 Annual Meeting
Studies Highlight Vectra DA for Assessing Treatment Response in Rheumatoid Arthritis
SALT LAKE CITY, Utah, Nov. 7, 2015 – Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, Inc. (NASDAQ: MYGN), today announced that new data on the use of Vectra DA to predict treatment response in patients with rheumatoid arthritis (RA) are being presented at the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) meeting being held Nov. 7-11, 2015 in San Francisco, Calif. Vectra DA is the first and only multi-biomarker blood test validated to measure disease activity in patients with RA and has been evaluated in multiple studies, resulting in 17 scientific publications.
“Much work has been done over the past decade to develop and validate Vectra DA, and establish the test as an objective measure for assessing disease activity in patients with rheumatoid arthritis,” said Elena Hitraya, M.D., Ph.D., chief medical officer, Crescendo Bioscience. “This year, our collaborators are presenting data on the role of Vectra DA in predicting response to second-line therapy. In addition, data will be presented examining Vectra DA’s ability to predict which patients may be able to successfully taper or withdraw from treatment. These data are important and deserve further exploration because they have the potential to help physicians tailor treatment plans for their patients and improve the use of healthcare resources.”
A summary of the highlighted Crescendo Bioscience presentations at ACR (#ACR15) follows:
Title: The multi-biomarker disease activity score in methotrexate incomplete responders predicts clinical responses to non-biological vs. biological therapy in early RA.
Authors: K. Hambardzumyan, R. Bolce, S. Saevarsdottir, K. Forslind, J.A. Karlsson and R.F. van Vollenhoven.
Date: Sunday, Nov. 8, 2015: 9:00 – 11:00 a.m. PT.
Location: Poster, Abstract 618.
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 MTX incomplete responders (MTX-IR). The findings demonstrated that, in patients with early RA and incomplete response to MTX, the Vectra DA test predicted the relative efficacy of second-line treatment with triple therapy versus anti-TNF.
“Predicting response to drug therapy is an important goal for personalizing treatment for individuals with RA,” said Ronald F. van Vollenhoven, M.D., Ph.D., Department of Medicine, Karolinska Institute in Stockholm, Sweden and the study’s lead investigator. “In this study, patients with a low Vectra DA score were more likely to respond to conventional triple therapy than to anti-TNF therapy. These findings may help facilitate and improve the development of individualized and cost-effective treatment plans for patients with RA.”
Title: Prediction of disease relapses by multi-biomarker disease test activity in rheumatoid arthritis patients tapering DMARD treatment.
Authors: J. Rech, A.J. Hueber, M. Englbrecht, S. Finzel, J. Haschka, B. Manger, A. Kleyer, M. Reiser, H-P Tony, S. Kleinert, M. Feuchtenberger, M. Fleck, K. Manger, W. Ochs, M. Schmitt-Haendle, J. Wendler, F. Schuch, M. Ronneberger, H-M Lorenz, H. Nüßlein, R. Alten, J. Fogagnolo Cobra, J.C. Henes, K. Krüger and G.A. Schett.
Date: Tuesday, Nov. 10, 2015: 9:00 – 11:00 a.m. PT.
Location: Poster, Abstract: 2584.
This study analyzed the role of Vectra DA in predicting disease relapse in patients with RA in sustained remission, following the tapering of treatment with disease modifying anti-rheumatic drugs (DMARDs). Vectra DA improved the prediction of relapse in RA patients in stable remission undergoing DMARD tapering. Additionally, when combined with anti-citrullinated protein antibody (ACPA) status, Vectra DA resulted in a correct case classification of relapse in approximately 80 percent of patients.
Title: Multi-biomarker disease activity score as a predictor of flare in patients with rheumatoid arthritis who stop TNF-alpha-inhibitor therapy.
Authors: F. Lamers-Karnebeek, M. Ghiti Moghadam, H.E. Vonkeman, J. Tekstra, A. Schilder, H. Visser, P.M. ten Klooster, E.H. Sasso, D. Chernoff, W. Lems, D. van Schaardenburg, R. Landewé, L. Van Albada, T.R.D.J. Radstake, P. van Riel, M.A.F.J. van de Laar and T. Jansen.
Date: Tuesday, Nov. 10, 2015: 9:00 – 11:00 a.m. PT.
Location: Poster, Abstract: 2594.
This study evaluated the Vectra DA score as a predictor of flare after discontinuation of treatment with tumor necrosis factor inhibitor (TNFi). Data were assessed from 439 RA patients who were randomized to stop TNFi treatment in the Dutch multi-center POET trial. The Vectra DA score was evaluated in all patients at baseline. Flare was defined as: 1) re-initiating TNFi treatment, 2) escalation of any medication, and 3) physician-reported flare. This study found that a high Vectra DA score at baseline was an independent predictor of flare within 12 months of discontinuing TNFi therapy.
For more information about these presentations, including a complete list of abstracts and presentations, please visit the ACR website at http://acrannualmeeting.org/abstracts/.
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, BRACAnalysis, 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 to be presented at the 2015 American College of Rheumatology (ACR) Annual Meeting, November 7-11, 2015, in San Francisco, Calif.; the Company’s commitment to understanding the molecular underpinnings of rheumatoid arthritis and autoimmune disorders; the ability of Vectra DA to predict or assess treatment response in patients with rheumatoid arthritis; 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; 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, 2015, 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.