Health Problem: Rheumatoid arthritis (RA) is a chronic, progressive, systemic inflammatory disease leading to destruction of joint cartilage and bone, with consequent disability. This disease affects > 1.3 million people in the United States and > 4 million persons worldwide. Several new disease-modifying antirheumatic drugs (DMARDs) have been developed in the past decade, but response to these agents is unpredictable and the severity of RA varies greatly among patients. Recommendations emanating from recent studies emphasize what is referred to as a treat-to-target strategy, i.e., early treatment for moderate-to-severe disease, tight control of disease, frequent assessment, and liberal revisions of the therapeutic regimen for patients who do not respond adequately.
Technology Description: The Vectra DA test is a multi-biomarker blood test that measures levels of 12 key proteins. A weighted algorithm based on the levels of these markers is used to calculate the multi-biomarker disease activity (MBDA) score, yielding a single number ranging from 0 to 100, with disease activity ranked as low (1-29), moderate (30-44), or high (> 44). The intended use of the Vectra DA test, also referred to as the MBDA test, is to assess disease activity in patients with RA and inform treatment decisions in conjunction with standard clinical assessments. Although it is not a diagnostic test and does not guide selection of specific therapies, the MBDA score may provide a baseline assessment of disease activity, corroborate other clinical findings, and clarify disease activity when clinical assessment is challenging or when laboratory findings, symptoms, or other test results are conflicting. The Vectra DA test is used by rheumatologists in the outpatient setting to assess RA disease activity in patients who have a confirmed diagnosis of this disease.
Controversy: The Vectra DA test is sophisticated, but it may not provide any significant benefit to patients. Clinical management that relies on regular reassessment of patient symptoms and repetition of simple blood tests may guide RA management as effectively as strategies that include the Vectra DA test.
Key Questions:
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Is the Vectra DA test more accurate than other methods for assessment of RA disease activity?
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Can the information obtained with the Vectra DA test be used to improve management of patients who have RA?
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Does the Vectra DA test pose any safety issues?
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Have patient selection criteria been established for the Vectra DA test?
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