The Centers for Disease Control and Prevention (CDC) has awarded four contracts worth $11.4 million in an effort to develop a 30-minute test for H5N1 avian influenza.

The CDC said it awarded the funds to spur development of tests that doctors and field epidemiologists could use to test patients for both H5N1 and other flu viruses. Currently, testing for H5N1 in the United States must be done in 1 of about 100 designated laboratories and takes from 4 to 24 hours, depending on shipping time, the CDC said.

Last month the World Health Organization (WHO) listed a rapid diagnostic test as one of the top priorities in avian and pandemic flu research. The CDC said it hopes a rapid test can be ready and licensed within 2 to 3 years.

"The creation of a point-of-care test to rapidly detect human cases of H5N1 avian influenza would be a major step forward in our ability to protect public health," Health and Human Services Secretary Mike Leavitt said in a news release.

The four companies, their tests, and the contract amounts are as follows:

• Cepheid, Sunnyvale, Calif.—GeneXPert Flu assay, $2.4 million
• Iquum, Marlborough, Mass.—LIAT, Lab-in-a-Tube, $3.8 million
• MesoScale, Gaithersburg, Md.—Multi-Array Detection, $706,241
• Nanogen, San Diego—a novel point-of-care immunoassay system, $4.5 million

Over the next year, the companies will work to develop tests that can detect flu viruses and distinguish seasonal strains from H5N1 within 30 minutes, the CDC said. Existing rapid tests can tell only if a patient has a seasonal influenza A or B virus.

CDC spokeswoman Christine Pearson told CIDRAP News the contracts are intended to fund the first two of five development phases.

The goal for the first two phases is to produce a prototype test that can be evaluated by the CDC, said Dr. Rueben Donis, chief of the molecular virology and vaccines branch in the CDC´s influenza division. He said the agency will fund further development only if the prototype has "acceptable performance characteristics."

In a news release, Nanogen said that if the CDC funds all five development phases, the company would receive a total of about $12.5 million over the next 2 to 3 years.

The four companies were chosen from 13 applicants, the CDC said. Selection criteria included the technical specifications of the test, experience in developing diagnostic tools, staff expertise, and access to labs with sufficient security to handle H5N1 viruses.

The agency also promised to provide funds for a repository of influenza reagents and other materials to help in development of the tests.

See also:

Dec 4 CDC news release
http://www.cdc.gov/od/oc/media/pressrel/r061204.htm