Nanogen announces clinical diagnostic to simultaneously detect multiple respiratory viruses

Nanogen 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(R) 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(R) 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(R) 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(R) 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(R) 400 can provide clinical laboratories with an advanced diagnostic platform for improving healthcare."