FDA CLEARS WAIVED CBC FOR NEAR-PATIENT TESTING

Sysmex Granted First-Ever FDA Clearance of a CLIA-Waived CBC Analyzer for Hematology

CEO SUMMARY: Market clearance of the first-ever CLIA waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees its analyzer as a complement to central labs. Basic diagnostics would be performed in physician-operated laboratories while larger central labs continue to provide in-depth analysis and repeat testing.

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