Trinity Biotech plc., developer and manufacturer of diagnostic products for the point-of-care and clinical laboratory markets, has obtained the CE mark (European approval) for its Meritas point-of-care BNP test. The test will run on the same platform as Trinity's Troponin product for the detection of heart attacks.
Brain or B-type natriuretic peptide (BNP) levels in the bloodstream increase as the severity of heart disease proceeds. Thus, BNP has emerged as the principal biomarker in aiding the diagnosis of and determining the clinical severity of acute and chronic heart failure. In addition, BNP can be useful in a wide range of clinical applications including risk stratification and monitoring of patients with heart failure and heart attacks.
According to Trinity Biotech representatives, “The Meritas BNP test demonstrates exceptional sensitivity and precision, which is at least comparable to much larger and far more expensive central laboratory systems, while delivering results in ten minutes, right at the point of care. Existing competitive BNP tests have certain limitations due to the effects of sample degradation. This makes those tests challenging to use in primary care and in retrospective studies, where sample degradation may falsely lower test results. Due to its design, the new patented Meritas BNP test is not hindered by these limitations.”
In the wake of the CE Marking, Trinity Biotech is preparing for submission of the assay to the U.S. Food and Drug Administration (FDA) by the end of the first quarter of 2015. The company anticipates the approval of the BNP test during the third quarter of next year, which is expected to coincide with FDA approval of the Troponin product. Learn more about the range of solutions offered by Trinity Biotech.Read more