Only Multi-biomarker Blood Test Validated to Measure RA Disease Activity
South San Francisco, July 8, 2013 –Crescendo Bioscience, Inc., a molecular diagnostics company dedicated to developing quantitative blood tests and disease information services for rheumatoid arthritis (RA) and other autoimmune diseases, announced that Palmetto GBA, a Medicare contractor, has established national coverage for the company’s Vectra DA test to aid in the assessment of disease activity in conjunction with standard clinical assessment in adults previously diagnosed with RA. With this decision, Vectra DA is now a covered benefit for Medicare beneficiaries with RA in the United States.
There is a significant unmet need in RA for an accurate and precise disease activity assessment tool. Vectra DA simultaneously measures 12 immune, endothelial, bone, cartilage and metabolic biomarkers that reflect the underlying biology of RA. Serum concentrations of the biomarkers are integrated into a proprietary algorithm that generates a single score from 1 to 100 that classifies disease activity as low, moderate or high.
“Since its launch, doctors have been incorporating Vectra DA into routine rheumatology practice for a more insightful and quantitative assessment of disease activity in patients with RA,” said Michael Schweitz, M.D., Chief, Division of Rheumatology at Good Samaritan Medical Center, Palm Beach, FL. “Now, Medicare beneficiaries will have covered access to this important test that helps rheumatologists better manage patients with RA throughout the course of their disease.”
Vectra DA can help optimize patient management and therapeutic outcomes by supplementing the highly subjective and qualitative assessment tools routinely used in current clinical practice. This includes response to various therapeutic agents, determining the risk of joint damage, identifying which patients are in clinical remission, as well as assessing the effect of comorbidities such as fibromyalgia and osteoarthritis, which can interfere with accurate clinical assessments.
“We are very pleased that Medicare patients with RA will now have access to Vectra DA,” said William A. Hagstrom, President and Chief Executive Officer of Crescendo Bioscience. “RA is a complex disease with numerous clinical dilemmas. We believe that appropriate use of Vectra DA as an enabling technology can help physicians more efficiently and effectively match the clinical status of their patients with RA to the most appropriate management strategies for the disease.”
“Rheumatoid arthritis is a lifelong, debilitating disease that can cause severe disability, leaving many patients unable to work over time. Having a state-of-the-art tool like Vectra DA to provide deeper insights into the biology of this autoimmune disease allows patients with RA to better interact with their doctors and improve their overall health outcomes,” said Seth D. Ginsberg, President of the Global Healthy Living Foundation and founder of Creaky Joints, an advocacy organization for those affected by RA.
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. It is distinct from osteoarthritis, a degenerative disorder that can be caused by aging, heredity and/or injury from trauma or disease.
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 are qualitative, subjective, and they may not adequately identify key trends in the disease in a timely fashion.
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 first and 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) and CAP (College of American Pathology) accredited facility in South San Francisco, CA and test results are reported to the physician approximately one week following receipt of the blood sample. In addition to standard delivery options, physicians can receive test results via VectraViewTM, a private web portal.
With Vectra DA, physicians have an absolute metric that doesn’t depend on subjective inputs that can vary significantly and be difficult to interpret. By providing a specific and precise way to measure RA disease activity that complements a clinician’s expert assessment, Vectra DA helps facilitate more efficient management of patients. In addition to the advantages this provides in the context of an individual patient, Crescendo Bioscience developed VectraView – an online disease analytics tool that allows rheumatologists to order and manage Vectra DA tests, as well as evaluate the test results of all of their RA patients as a group. Furthermore, the Company has developed a patient support tool, a free iPhone app called MyRATM, that can help patients track their RA on a daily basis.
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 www.CrescendoBio.com.
Continuum Health Communications