Development of a lateral flow immunoassay device (IVD)

Challenge: An early stage biotech company had developed a novel technology for specific detection of various strains of flu virus. This led to feasibility demonstration of a product concept based on a lateral flow immunoassay. PharmaCRO was brought in to advance the product development through clinical studies and submission of the 510k on a very aggressive timeline, and to manage the project.

Solution: PharmaCRO worked closely with the client development team to finalize product design, manufacture clinical supplies, conduct clinical studies, identify and interface with contract research organizations for clinical data management and statistical analysis, and submit the 510k on schedule.

Result: Within three months after submission, during which time the queries from FDA were successfully addressed, the FDA responded with a favorable disposition toward approval. The 510(k) clearance was granted in April 2009, less than five months after submission of this novel Class II, Special Controls device. “This test is an important tool to help quickly identify emerging influenza A/H5N1 infections and reduce exposure to large populations,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health in the FDA press release following approval of the device. “The clearance of this test represents a major step toward protecting the public from the threat of pandemic flu.”