July 17, 2007&#8212San Diego-based Nanogen Inc., developer of advanced diagnostic products, is now shipping its congestive heart failure (CHF) product. The StatusFirst CHF NT-proBNP rapid test is CE-marked and has been cleared by the FDA for diagnostic use with EDTA plasma samples.

The StatusFirst CHF test measures circulating levels of NT-proBNP, a biomarker for heart disease, and provides a quantitative assessment of the biomarker’s concentration in as few as 15 minutes via a small, low-cost reader. NT-proBNP is a derivative of the hormone brain natriuretic peptide, which is released in response to cardiac stress and has been demonstrated in numerous clinical studies to be an accurate and reliable indicator of cardiac disease risk. The test and reader are designed for use in emergency rooms and hospital laboratories.

“With an aging population and more people surviving myocardial infarctions (MIs), the market for cardiac diagnostics related to heart failure is expected to exceed $500 million annually in the next five years,” says David Ludvigson, Nanogen president and chief operating officer.

The StatusFirst CHF product has been developed by Nanogen under license from Roche and is being manufactured for Nanogen by Princeton BioMeditech Corp.