Gen-Probe: FDA questions Procleix WNV Assay study

By Lisa Kerner

Charlotte, N.C., July 25 - Gen -Probe Inc. said the Food and Drug Administration's complete review letter on the company's Biologics License Application (BLA) supplement included questions related to a clinical migration study that Gen-Probe conducted comparing Procleix WNV Assay results on the eSAS to results on the fully automated Procleix Tigris System.

The WNV Assay was approved in December to run on the Procleix enhanced semi-automated instrument System.

The Procleix Tigris System, used in blood centers to screen donated blood for WNV under an Investigational New Drug application, can process 1,000 blood samples in about 14 hours.

"We remain confident that we are on a path toward full system approval based on the quality of our scientific data and the ongoing performance of our WNV Assay and Tigris System in the field," executive vice president for research and development Larry Mimms said in a company news release. "Based on our current information and analysis, we estimate that we will be able to respond to the FDA's questions within 90 days."

Gen-Probe is also preparing responses to the FDA's questions related to the company's pending 510(k) application for the Tigris System.

Gen-Probe, based in San Diego, develops nucleic acid tests used diagnose human diseases and screen donated human blood.

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