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Crescendo Bioscience to Present Data on the Use of Vectra(TM) DA in Assessing Response to Treatments at American College of Rheumatology/Associate Rheumatology Health Professional Annual Meeting

November 10, 2012 --

SOUTH SAN FRANCISCO, Calif., Nov. 10, 2012 (GLOBE NEWSWIRE) -- Crescendo Bioscience®, a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other auto-immune diseases, announced today that it will present data from several studies that confirm Vectra™ DA's performance in measuring changes in disease activity in patients with RA following treatment with a number of therapies including traditional disease-modifying anti-rheumatic drugs (DMARDs) and biological therapies at the American College of Rheumatology/Associate Rheumatology Health Professional (ACR/ARHP) annual meeting, held in Washington, DC, November 11-14. The clinical data from these studies add to the growing body of evidence that Vectra DA can provide rheumatologists objective insight into the molecular disease activity of rheumatoid arthritis to potentially help them make better treatment decisions for their patients.



"Data presented at this meeting provide further evidence for the use of Vectra DA as a standardized clinical decision support tool to assess and quantify a patient's response to traditional DMARDs and biological agents, including anti-TNF therapies and oral kinase inhibitors," said Oscar Segurado, M.D., Ph.D., Chief Medical Officer at Crescendo Bioscience. "These studies are an extension of data previously collected using Vectra DA to advance our understanding of remission, radiographic progression and co-morbidities in RA, which provides valuable information to the physician. We continue to expand our clinical evaluation of Vectra DA into a broader spectrum of therapies."



Oral Presentation


In an oral presentation (Abstract Session #2664) scheduled for November 14 at 12:15 pm, A Multi-Biomarker Disease Activity (VECTRA™ DA Algorithm) Score Reflects Clinical Disease Activity and Tracks Responses in Patients with Rheumatoid Arthritis Treated With Either Adalimumab, Etanercept and Infliximab, researchers will discuss Vectra DA's multi-biomarker disease activity score (MBDA) as a tool to assess disease activity in response to anti-TNF therapies, a class of biologic drugs used to treat moderate to severe RA.




"In measuring patient response to anti-TNF therapies, we found that Vectra DA is an objective and reproducible tool to measure the underlying molecular disease activity in response to treatment," states Yoshiya Tanaka, M.D., Ph.D., Professor and Chairman,The First Department of Internal Medicine, School of Medicine, and Deputy Director, the University of Occupational and Environmental Health in Katakyushu, Japan, and principal investigator. "These data demonstrate the potential for Vectra DA to be incorporated into routine rheumatology practice to more accurately track and manage treatment response and to achieve low disease activity and remission in patients with RA."



This study was conducted at the First Department of Internal Medicine at the University of Occupational and Environmental Health in Katakyushu, Japan, and included 147 patients with RA who received anti-TNF therapy (49 adalimumab, 49 etanercept, 49 infliximab).



Using the Vectra DA blood test, based on a proprietary 12-biomarker algorithm, researchers measured the level of disease activity of these patients at the beginning of treatment (baseline) and at 52 weeks. The Vectra DA score, ranging from 1 to 100, was compared with evaluations using standard clinical assessment with DAS28/SDAI/CDAI.



Researchers found that the Vectra DA score corresponded with clinical disease activity measurements in patients receiving anti-TNF therapy, showing a decrease of the score when there was a response to treatment. There were no differences found in the relationship between the Vectra DA scores and DAS28 scores for the different anti-TNF therapies. The study concluded that molecular disease activity measured with the Vectra DA score correlates with clinical disease activity in patients treated with anti-TNF therapies.



Vectra DA Posters Presented at ACR Annual meeting



Additional study results (presented in five posters listed below) further demonstrate and confirm Vectra DA's ability to objectively assess disease activity in response to a number of RA treatments, including methotrexate and anti-TNF treatments, as well as abatacept, tocilizumab and tofacitinib,the newly FDA-approved RA treatment. There is also data that shows Vectra DA correlates to changes in synovitis (inflammation of the synovial membrane that lines joints) and osteitis (inflammation of the bone) by MRI while DAS28 did not show correlation.



Abstract# 2159



Correlation of a Multi-Biomarker Disease Activity Response Assessment to Disease Activity Score 28 (C-Reactive Protein) Response Assessment and OMERACT RAMRIS Score in a Placebo-Controlled Rheumatoid Arthritis Clinical Trial with Abatacept (ASSET); D.J. Haney, Crescendo Bioscience, South San Francisco, and collaborators.



Abstract# 2121



A Multi-Biomarker Disease Activity (VECTRA DA Algorithm) Score Reflects Clinical Disease Activity and Structural Changes in Rheumatoid Arthritis Patients Treated with Tocilizumab; Y. Tanaka, The First Department of Internal Medicine, University of Occupational and Environmental Health, Katakyushu, Japan, and collaborators.



Abstract# 2162



Correlation of Multi-Biomarker Disease Activity (VECTRA DA) Score with Clinical Disease Activity and Its Components with Radiographic Progression in Rheumatoid Arthritis Patients Treated with Tofacitinib; K. Yamaoka, The First Department of Internal Medicine, University of Occupational and Environmental Health, Katakyushu, Japan, and collaborators.



Abstract# 2130



Studies of Disease and Therapy-Response Biomarkers in Early Rheumatoid Arthritis Treated with Methotrexate; A. H. Hensvold, Rheumatology unit, Karolinska University Hospital, Karolinska Institute, and collaborators.



Abstract# 2125



Response to Methotrexate Plus Prednisone in CAMERA II Using a Multi-Biomarker Disease Activity (Vectra DA) Test and DAS28-ESR; J.W.J. Bijlsma, University Medical Center Utrecht, The Netherlands, and collaborators.



Arthritis Care & Research Publication



Arthritis Care & Research recently published a manuscript online on the use of Vectra DA in adults diagnosed with RA from different cohorts in multiple centers. The study showed that Vectra DA provides a valid and objective measure of disease activity. The results supported the use of Vectra DA as a complement to existing clinical assessments to help clinicians measure RA disease activity over time and in response to RA treatments so as to impact care as well as potentially improve patient outcomes.



About Rheumatoid Arthritis (RA)



RA is a debilitating, highly variable, chronic disease affecting approximately 1.5 million Americans and more than two million people in Europe. The primary symptoms of RA are painful swollen joints and fatigue, with the disease often resulting in joint damage and disability. RA is a systemic disease that can significantly affect other parts of the body, resulting in infection, osteoporosis, cardiovascular disease, and causes an increased rate of mortality.



Clinicians assess RA based on three factors: disease activity (clinical signs and symptoms), structural damage in joints, such as erosions, and functional status (including pain). Many of the current clinical assessment tools used by physicians are qualitative and subjective and they may not adequately identify key properties of the disease.



Early and accurate detection of RA, accompanied by effective therapy with frequent monitoring of disease activity, is critical for optimizing clinical outcomes. The American College of Rheumatology has developed guidelines supporting the goals of "Treat to Target" and "Tight Control" to help clinicians achieve clinical and structural remission in their patients, and improve their long-term functional status.



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 to help physicians make more informed treatment decisions. Vectra DA testing is performed at Crescendo Bioscience's state-of-the-art CLIA (Clinical Laboratory Improvement Amendments) facility and test results are reported to the physician 7 to 10 days following receipt of the blood sample. 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®, Inc.



Crescendo Bioscience is a molecular diagnostics company focused in rheumatology and located in South San Francisco, CA. Crescendo Bioscience develops quantitative, objective, blood tests to provide rheumatologists with deeper clinical insights to help enable more effective management of patients with autoimmune and inflammatory diseases. For more information, please visit the company's website at http://www.CrescendoBio.com.


CONTACT: Media Contact:
Terri Clevenger
Continuum Health Communications
203-856-4326
tclevenger@continuumhealthcom.com

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