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Nanogen Receives 510(k) Clearance for StatusFirst(TM) Congestive Heart Failure NT-proBNP Test |
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30 Mar 2006 |
SAN DIEGO, CA, USA | Mar 29, 2006 | Nanogen, Inc. (Nasdaq: NGEN), developer of advanced diagnostic products, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its StatusFirst(TM) CHF NT-proBNP EDTA plasma test to aid in the diagnosis of individuals suspected of having congestive heart failure (CHF).
"This is the first 510(k) clearance earned by Nanogen and is a significant milestone," noted Howard C. Birndorf, chairman of the board and CEO of Nanogen. "The StatusFirst CHF 510(k) plasma clearance will permit us to begin the commercial launch of our CHF test. We will continue our development work to achieve clearance of the StatusFirst CHF whole blood test, which would significantly expand the potential market for our CHF product."
The StatusFirst CHF product results from collaboration between Nanogen and Princeton BioMeditech Corporation (PBM), an established rapid diagnostic test manufacturer. Nanogen and PBM have co-developed and will co-market the product. PBM will manufacture the product under contract with Nanogen. The StatusFirst CHF test is sold in conjunction with the DXpress reader, a qualitative and quantitative instrument supplied by PBM.
About Nanogen, Inc.
Nanogen's advanced technologies provide researchers, clinicians and physicians worldwide with improved methods and tools to predict, diagnose, and ultimately help treat disease. The company's products include real-time PCR reagents, the NanoChip(R) electronic microarray platform and a line of reagents useful in rapid diagnostic tests. Nanogen's ten years of pioneering research involving nanotechnology holds the promise of miniaturization and continues to be supported for its potential for diagnostic and biowarfare applications. For additional information please visit Nanogen's website at http://www.nanogen.com.
Forward-Looking Statement
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements, including whether patents owned or licensed by Nanogen will be developed into products, whether the patents owned by Nanogen offer any protection against competitors with competing technologies, whether products under development can be successfully developed and commercialized, whether results reported by our customers or partners can be identically replicated, and other risks and uncertainties discussed under the caption "Factors That May Affect Results" and elsewhere in Nanogen's Form 10-K or Form 10-Q most recently filed with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Nanogen disclaims any intent or obligation to update these forward-looking statements.
SOURCE: Nanogen, Inc |
