Triage Stroke Panel PMA Accepted for Review by FDA

Biosite, a research-based provider of novel, rapid medical diagnostics, announced the FDA has notified the company that the agency has accepted the Triage Stroke Panel premarket approval application (PMA) for further review. The panel is intended to be used as an aid in the assessment and diagnosis of cerebral ischemia (stroke). The Triage Stroke Panel consists of multiple biomarkers and utilizes a proprietary algorithm to calculate a single MultiMarker Index result.

PR Newswire (http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/02-21-2005/0003064966&EDATE=)