Biosite to withdraw Triage Stroke Panel PMA

By Lisa Kerner

Erie, Pa., May 17 - Biosite Inc. said it intends to voluntarily withdraw its Premarket Approval Application (PMA) for the Triage Stroke Panel, currently on hold with the Food and Drug Administration.

"Withdrawing the PMA submission will allow us the time and flexibility to tailor a clinical trial strategy that improves the prospects for U.S. regulatory approval and commercial success of the Triage Stroke Panel," chairman and chief executive officer Kim Blickenstaff said in a company news release.

By withdrawing its PMA application, Biosite can focus on its pipeline of potential new products, including the Triage Stroke Panel.

Biosite originally submitted the Triage Stroke Panel PMA to the FDA in January 2005. The FDA questioned methodological issues in the clinical trial supporting the PMA as well as the product's performance for its intended use.

"Our initial trial was complicated by the variability in stroke care among our trial sites," Blickenstaff added in the release.

"From a resource and knowledge standpoint, we believe we are better prepared today to design and complete effective clinical studies for the Triage Stroke Panel and other potential products."

San Diego-based Biosite commercializes proteomics discoveries for the advancement of medical diagnosis.

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