The US Food and Drug Administration has granted a CLIA waiver for Biosite Inc.’s Triage BNP Test, substantially expanding healthcare professionals' access to the 15-minute blood test to aid in the diagnosis and assessment of patients with symptoms of heart failure. The CLIA waiver will expand access to the test among physician office laboratories and decentralized hospital sites of service, allowing more patients to benefit from rapid evaluation, the company announced here.

"Early detection and aggressive treatment is the best way to slow progression of heart failure and reduce its high morbidity and mortality," Jay N. Cohn, professor of medicine at the University of Minnesota said adding, "To the extent that BNP assays can aid in that early detection, it is a valuable contribution to effective healthcare."

The Triage BNP Test is a rapid immunoassay blood test that aids in the diagnosis of congestive heart failure (also known as heart failure), assessment of disease severity and in the risk stratification of patients with acute coronary syndromes (ACS). Previously, use of the test in physician office laboratories was limited to the approximately 18,000 facilities licensed to perform moderately complex tests.

While the American Heart Association (AHA) reports that approximately 550,000 new cases of heart failure were diagnosed in 2002, many people are not diagnosed until the disease has reached an advanced stage. If left untreated, heart failure, which impairs cardiac function and reduces blood flow, can result in tissue and organ damage. Symptoms, including shortness of breath, chest pain, fatigue, swelling and loss of appetite, often occur in the late stages of the disease, after irreversible heart damage has already occurred.

BNP, b-type natriuretic peptide, is a naturally occurring hormone in the body. When the heart is unable to pump blood efficiently, BNP is produced to ease its workload. BNP appears to relax blood vessels (vasodilation), increase the excretion of sodium (natriuresis) and fluid (diuresis) and decrease neurohormones that lead to vessel constriction, fluid retention and elevated blood pressure.