SAN DIEGO, March 29 /PRNewswire-FirstCall/ -- 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
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
SOURCE Nanogen, Inc.