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
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
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.