Nanogen to Develop Molecular Diagnostic Test for Influenza

Nanogen, Inc. (San Diego, CA, USA), has been awarded a US$10.4 million, two-year contract from the U.S. Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) to develop a multi-analyte molecular diagnostic assay for influenza.

The molecular diagnostic test will be developed in partnership with the Medical College of Wisconsin (MCW; Milwaukee, WI) and HandyLab, Inc. (Ann Arbor, MI, USA), a company dedicated to the development and manufacture of novel clinical diagnostic testing products. It will be more sensitive than current rapid flu tests and is expected to take 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.

The development program will incorporate assay development that Nanogen has been working on in cooperation with MCW as part of a U.S. National Institutes of Health (NIH; Bethesda, MD, USA) grant for multiplexed infectious disease diagnostics. Nanogen will use its minor groove binder (MGB) probe technology for real-time polymerase chain reaction (PCR) and anticipates the use of off-the-shelf instrumentation for sample handling and detection, including the HandyLab, Raider instrument, a microfluidic real-time PCR technology, which will significantly shorten time to result.

The fast molecular test simultaneously detects and differentiates Influenza type A, Influenza type B, seasonal flu (H1N1 and H3N2) strains, and respiratory syncytial virus (RSV). 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 the strain Influenza A but negative for seasonal flu. RSV is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age.

The molecular diagnostic test will be developed in partnership with the Medical College of Wisconsin (MCW) and HandyLab. It will be significantly 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. These tests are intended as a key components of the CDC's two-pronged approach to quickly identify and respond to a potential flu pandemic.

Howard C. Birndorf, Nanogen's chairman of the board and CEO, said, "Recently, there have been a number of multiplexed molecular products for respiratory targets to hit the market. 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. We are excited and pleased to partner with MCW and HandyLab on this project.”


Related Links:
Nanogen
U.S. Centers for Disease Control and Prevention
National Institutes of Health