Goal is to develop POC immunoassay that simultaneously detects influenza type A, type B, seasonal flu (H1N1 and H3N2) and avian flu (H5N1) in a simple to use assay format
Nanogen has been awarded a $4.5 million contract from the US Centers for Disease Control and Prevention (CDC) to develop a unique multi-analyte point-of-care (POC) diagnostic assay for influenza in support of the US government's efforts to strengthen its readiness for a potential influenza pandemic.
The goal of the development is to employ proprietary Nanogen technology in a low cost, high sensitivity POC immunoassay that simultaneously detects influenza type A, type B, seasonal flu (H1N1 and H3N2) and avian flu (H5N1) in a simple to use assay format.
This development program is partnered with HX Diagnostics, which will commercialize the product upon approval.
The current award of $4.5 million funds the first two phases of a five-phase development project and, if all five phases are funded by the CDC, can total approximately $12.5 million over the next two to three years.
"The success of our bid is a strong endorsement of our capabilities as a diagnostic company and our expertise in areas like rapid immunoassay technology," said Howard Birndorf, Nanogen's chairman and CEO.
"A rapid test for bird flu could play a significant role in tracking infections and warding off epidemic spread of this dangerous virus".
The Nanogen product under development is a third generation high sensitivity lateral flow test designed to be accurate, highly portable, and simple to use yet with a cost similar to current influenza POC tests sold today.
The immunoassay technology underlying the design builds upon that employed in Nanogen's current cardiac infarction products, which are capable of delivering results at the point of care in as little as 15 minutes.
The test format is also designed to be readily adapted to detect new strains of the influenza virus as they emerge.
Once commercialised, health professionals could use this test to diagnose seasonal influenza and as an early warning system to identify individuals with typical flu symptoms who may harbour a potentially pandemic subtype, giving public health officials early notice of the emergence of a new subtype.
Also, as it will be in general use for seasonal flu testing, it would be immediately available to deploy to rapidly and accurately differentiate people with similar symptoms as having non-flu, seasonal-flu or pandemic-flu in the event of a pandemic.
Nanogen believes this product will be highly competitive and will meet all criteria for cost, performance, ease of use, and be highly deployable with a long shelf life.
