Crescendo BioscienceTM Announces the U.S. Launch of the First Multi-Biomarker Blood Test for Rheumatoid Arthritis Disease Activity
South San Francisco, Calif. — November 8, 2010—Crescendo Bioscience announced today the commercial launch of Vectra DA, its first-in-class multi-biomarker blood test designed to aid physicians in managing patients with rheumatoid arthritis (RA). Vectra DA analyzes 12 key serum biomarkers to produce a single objective score that quantifies RA disease activity. Launched today at the ACR/ARHP Annual Scientific Meeting , Vectra DA is now available to physicians in 47 states (laboratory licensure has been applied for in Maryland and Rhode Island and is planned for New York).
"We are excited to offer rheumatologists a new quantitative tool that provides deeper insights into the molecular biology of RA which can complement their clinical assessments," said David Chernoff, M.D., Chief Medical Officer of Crescendo Bioscience. "The physicians who have had early access to Vectra DA have welcomed the availability of this quantitative molecular measure of RA disease activity. We look forward to bringing the biological insights of Vectra DA to rheumatologists across the U.S."
Vectra DA was developed through a rigorous stepwise approach using a broad survey of RA biology and over 1600 patient samples from key North American and European clinical trials and registries. The development process evaluated hundreds of potential biomarkers and, through a series of studies, trained an algorithm that uses 12 biomarkers to robustly assess disease activity. The test is performed on blood samples sent to Crescendo Bioscience’s CLIA-certified clinical laboratory.
"We are all committed to the concept of 'treat to target', monitoring RA disease activity frequently with a specific quantitative goal and personalizing RA care based on the resulting measurements, but in the real world, in a busy practice, few actually attain it.", said Steve Paget, M.D. Physician-in-Chief Emeritus, Hospital for Special Surgery. "Vectra DA, a blood test that quantifies RA disease activity, can help make this a reality for every RA patient and help guide rheumatologists in defining a patient's immunological burden at any given time."
In conjunction with the launch of Vectra DA, Crescendo Bioscience has also established the Crescendo Access and Reimbursement Essentials (CARE) program, a financial assistance program for uninsured and under-insured patients designed to provide access to Vectra DA for those with financial need. The Company is also developing VectraView—a secure, user friendly portal that provides health care professionals with a simple, seamless way to order Vectra DA tests, track the status of test orders and review results.
Vectra DA is the first of a planned suite of comprehensive diagnostic, prognostic, therapy selection and monitoring tests to help inform physician decisions and improve patient outcomes in patients with autoimmune disorders.
Presentations at the ACR /ARHP Annual Scientific Meeting
Studies documenting the development and validation of Vectra DA are being presented at the ACR/ARHP Annual Scientific Meeting this week. These presentations include:
* An independent validation study demonstrating that Vectra DA accurately quantifies RA disease activity, as compared to validated clinical indices, in a large patient population, Abstract 1782.
* A presentation on the development of Vectra DA, focused on the unique bioinformatic approach used by Crescendo Bioscience, Abstract 1753.
* A technical study characterizing pre-analytical sample handling variables to ensure the accuracy of Vectra DA, Abstract 1606.
* Data supporting a new product in late-stage development (the Structural Damage test) that provides evidence of the ability of serum biomarkers to improve prediction of structural damage progression over standard clinical measures in RA patients, Abstract 1496.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a debilitating, highly variable, chronic disease affecting approximately 1.5 million Americans and more than 2 million people in Europe. The primary symptoms of RA are joint inflammation, pain, and fatigue, with the disease often resulting in joint damage and disability. RA is a systemic disease and can significantly damage other parts of the body as well, resulting in infection, osteoporosis and cardiovascular disease, a leading cause of death for RA patients. Early and accurate detection of RA, followed with frequent monitoring and responsive therapeutic adjustments, is critical to improving clinical outcomes.
About Vectra™ DA
Vectra DA is the first multi-biomarker blood test for RA disease activity. It allows physicians to go beyond signs and symptoms for deeper insights into disease biology that can complement clinical assessments and routine laboratory tests. Vectra DA integrates information from 12 key biomarkers that have consistently been shown to be associated with RA disease activity into a single quantitative score. Vectra DA serves as a baseline assessment of disease activity and a tool to track subsequent changes. Vectra DA is validated for use in adults diagnosed with RA. Test results are intended to aid in the assessment of disease activity in RA patients when used in conjunction with standard clinical assessment. This test is not intended or validated to diagnose RA. 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 is developing quantitative, objective, biology-based 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 www.crescendobio.com.