Trinity Biotech plc. (Nasdaq: TRIB), today announced it has obtained the CE mark (i.e. European approval) for its Meritas point-of-care BNP test.
Heart failure, also referred to as chronic or congestive heart failure, is a complex progressive syndrome that impacts about 26 million people worldwide with almost 700,000 new cases diagnosed each year in the United States alone. Heart failure is a serious condition in which the heart cannot pump enough blood to meet the needs of the body. Although often life threatening, the typical symptoms of heart failure (breathlessness, fatigue and swelling of the limbs) are usually less dramatic than those associated with a heart attack. In economically developed countries, up to one in five people are expected to develop heart failure at some point in their life. As the symptoms of heart failure are variable and non-specific, blood-based biomarkers are frequently used to assist in the difficult diagnosis of heart failure.
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. 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.
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