NEW YORK (GenomeWeb) – InDevr announced today that it has signed a contract with the Biomedical Advanced Research and Development Authority to finish the development of a microarray-based test for influenza.
Should it complete project milestones, Boulder, Colo.-based InDevr could receive up to $14.7 million to see the array, called FluChip-8G, through to commercialization.
BARDA's support will "enable us to complete the final stages of product development and conduct clinical studies for a 510(k) submission" to the US Food and Drug Administration, said InDevr CEO Kathy Rowlen. "If all goes well, we will launch the first commercial version of FluChip-8G in 2016."
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services. Part of the office's mission is to support the development of new tests for influenza viruses.
FluChip-8G is capable of rapidly genotyping influenza viruses directly from clinical samples, according to the firm. Should it garner FDA clearance, the company said it will market the test to hospitals, urgent care facilities, and clinical laboratories, enabling physicians to "rapidly distinguish between seasonal strains and potential pandemic non-seasonal strains of the influenza virus, such as H5N1 or H7N9."