NEW YORK (GenomeWeb News) — The US Centers for Disease Control and Prevention has awarded $11.4 million to Cepheid, Nanogen, and two other companies developing “quick” and “accurate” field-deployable tests to diagnose H5N1 avian flu and other influenza viruses, the CDC said yesterday.
The CDC said it intends to work with the US Food and Drug Administration to help tests developed from the program to receive FDA clearance and be ready for commercialization “within two to three years.”
Nanogen pocketed $4.5 million to develop “a novel point of care immunoassay system.” In its own statement, Cepheid said its award covers phases one and two of a five-phase, 30-month program.
Nanogen said it will use the cash to develop a third-generation lateral flow immunoassay that will cost about the same as other POC tests on the market. If the CDC continues funding Nanogen through phases three through five, the entire project value for the company could total $12.5 million.
Cepheid has won $2.4 million to develop flu assays on its GeneXPert platform. The company said it has been contracted to develop an automated test for use on the GeneXpert system using real-time PCR, which will not require specific expertise or specialized training.
The two other companies include Iquum, based in Marlborough, Mass., which received $3.8 million to develop a lab-in-a-tube system, and MesoScale, of Gaithersburg, Md., which won $706, 241 to develop its multi-array detection system.
The $3.8 million Iquum received for phases one and two will be used to develop nucleic acid tests based on its lab-in-a-tube technology that will differentiate H5N1 from other flu viruses. Iquum did not say whether it expects to be contracted for the later phases of the project.
Calls to MesoScale were not immediately returned.
The CDC said it hopes to work with the companies over the coming year to create point-of-care tests that can detect and differentiate various flu viruses, including avian H5N1, in 30 minutes.
These tests would need to be easily adaptable to account for the ability of certain viruses to rapidly mutate, and to be ready for the swift emergence of unknown ones, the CDC said.
In a statement, CDC Director Julie Gerberding said the center hopes the contracts generate “promising technology that could help doctors treat their patients faster and help public health authorities track influenza viruses that could spur a pandemic."