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Nanogen Begins Shipment of Congestive Heart Failure Product

Nanogen, Inc., developer of advanced diagnostic products, announced today that it has begun shipment of its congestive heart failure (CHF) product, the StatusFirstTM CHF NT-proBNP rapid test. The product 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 little as 15 minutes via a small, low cost reader. The test and reader are designed for use in emergency rooms and hospital laboratories.

"With an aging population and more people surviving myocardial infarctions (MI), the market for cardiac diagnostics related to heart failure is expected to exceed $500 million annually in the next five years," said David Ludvigson, Nanogen president and chief operating officer. "This product was developed by Nanogen and complements the rapid cardiac tests for MI we acquired last year. The StatusFirst CHF product is an important addition as we build our point-of-care rapid testing franchise."

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 StatusFirst CHF product results correlate with central lab methods that use NT-proBNP immunodiagnostic methods. A version of the product that will use whole blood for the sample is currently under development for the U.S. market, which will improve its marketability for use in emergency departments and other critical care settings.

The StatusFirst CHF product has been developed by Nanogen under license from Roche and is being manufactured for Nanogen by Princeton BioMeditech Corporation (PBM). Distribution in the United States will be handled by PBM’s affiliate LifeSign.

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