Nanogen Inc, San Diego, a developer of in vitro diagnostic products, landed a new $10.4 million, two-year contract from the Centers for Disease Control and Prevention (CDC) to develop a multi-analyte molecular diagnostic assay for influenza.
Nanogen plans to develop a fast molecular test that simultaneously detects and differentiates influenza types A and Type B, seasonal flu (H1N1 and H3N2) strains, and respiratory syncytial virus. The contract provides for a secondary, reflex test for avian flu strains (H5N1, H7N1, and H9N1) to be available for samples that are determined to be positive for flu A but negative for seasonal flu.
"Receiving a second significant contract from the CDC is a strong endorsement of our capabilities as a diagnostic company and clearly shows recognition for our expertise in molecular biology and infectious disease,” said Howard C. Birndorf, the company’s chairman of the board and CEO. “This contract will increase funds for ongoing development of our market-leading, real-time PCR technology and an integrated system to improve ease of use in clinical laboratories.
RSV is the most common cause of bronchiolitis and pneumonia among infants and children under age 1.
The molecular diagnostic test will be developed in partnership with the Medical College of Wisconsin (MCW) and HandyLab Inc, Ann Arbor, Mich. The company says the test will be more sensitive than current rapid flu tests and is expected to be conducted in less than half the time it takes to run current molecular tests. The tests are intended as a key component of the CDC’s two-pronged approach to quickly identify and respond to a potential flu pandemic.
This is the company’s second CDC contract related to the development of diagnostic tests for influenza and complements its rapid test currently being developed in collaboration with HX Diagnostics Inc, Emeryville, Calif.
“Recently there have been a number of multiplexed molecular products for respiratory targets to hit the market," Birndorf said. "These products, however, are expensive and test for more pathogens than are useful in clinical diagnosis. Having a fast molecular assay that can be used as a confirmatory test for influenza will improve the tools available to clinicians for better patient health management.”
The molecular diagnostics development program will incorporate assay development the company has been working on in cooperation with MCW as part of an NIH grant for multiplexed infectious disease diagnostics. The proposal to the CDC included the use of Nanogen’s proprietary MGB probe technology for real-time PCR and anticipates the use of off-the-shelf instrumentation for sample handling and detection, including the HandyLab Inc Raider instrument, a microfluidic, real-time PCR technology, which will shorten time to result.
The contract further extends a long-standing partnership between the company and Kelly Henrickson, MD by using MCW’s new Midwest respiratory virus program. “Success in this project will significantly advance multiplex PCR use in the clinical laboratory and provide a unique hands-off solution for rapid, sensitive, and specific detection of seasonal respiratory viruses and pandemic influenza,” Henrickson said.
“Our collaboration with Nanogen on this project validates Raider’s performance for microfluidic real-time PCR technology,” said Mark Powelson, HandyLab’s VP of sales and marketing, “Our technology contribution to this project is anticipated to redefine the way respiratory testing is done.”
Five percent to 20% of the population nationwide is affected by the influenza virus annually, with some 36,000 deaths caused by the infection. Health care agencies such as the CDC are concerned about the possibility of a deadly subtype, like avian flu, rapidly emerging and causing a pandemic. By 2010, the worldwide influenza diagnostics market is likely to reach $200 million.
Nanogen’s products include molecular diagnostic kits and reagents, and kits for rapid point-of-care testing.
