Nanogen, Inc.,
developer of advanced diagnostic products, announced today that it is
developing new analyte specific reagents (ASRs) for clinical reference
laboratories to develop and validate a single test to detect six of the most
common respiratory viruses. Instead of testing for multiple viruses using
individual tests, clinical laboratories could utilize Nanogen's gene-based
respiratory viral ASRs to develop their own test for influenza A, influenza B,
human parainfluenza 1, human parainfluenza 2, human parainfluenza 3 and
respiratory syncytial virus A/B in a single panel. The ASRs also provide
laboratories with the capability to develop a test that can detect dual
infections, which previously required additional time and tests. The
NanoChip respiratory viral ASRs will be available to high complexity
CLIA-certified clinical reference laboratories in the U.S. in 2005. The ASRs
incorporate multiplexing technology developed by Prodesse, Inc.
During a presentation at the Association for Molecular Pathology (AMP)
annual meeting, Nanogen highlighted the potential use of respiratory virus
ASRs on the recently introduced NanoChip 400. The reagents and instrument
can provide clinical laboratories with an advanced microarray platform for
laboratories to develop gene-based tests that can generate results in one day
versus culture-based tests that can take as much as a week. In addition, the
ASRs can be validated by the laboratories for use with their current sample
preparation methodologies, streamlining workflow.
There are over 400,000 hospitalizations due to respiratory diseases each
year. The six viruses included in the Nanogen ASRs can cause upper and lower
respiratory tract infections including bronchiolitis, pneumonia and croup and
can lead to serious illness or death. A large number of infectious disease
diagnostic tests are culture-based, and labs often take a week or longer to
produce results. Consequently, physicians frequently prescribe antibiotics or
anti-virals prior to determining the exact pathogen causing the infection.
Pathogen-based tests may allow physicians to improve appropriate treatment
with antibiotics, the overuse of which has resulted in an increase in
antibiotic-resistant strains of bacteria and a decrease in the effectiveness
of many commonly prescribed antibiotics. The NanoChip respiratory viral
ASR's will help make it possible for physicians to prescribe therapeutics in
response to test results.
AMP meeting attendees can be briefed on the new analyte specific reagents
run on the NanoChip 400 as well as learn more about other infectious
disease diagnostics marketed by Nanogen, including Epoch Biosciences' real-
time PCR ASRs. The product portfolio includes a variety of products, from
simple to complex molecular assays, suited to research and clinical laboratory
customers' needs.
"Nanogen is entering the large marketplace for infectious disease with a
highly sensitive, rapid approach that far exceeds the capabilities of standard
culture-based tests," said Howard C. Birndorf, Nanogen chairman and chief
executive officer of Nanogen. "We plan an aggressive marketing launch in
2005, when the combination of our respiratory viral ASR's and the NanoChip
400 can provide clinical laboratories with an advanced diagnostic platform for
improving healthcare."
