Research & Development
Sekisui Diagnostics wins FDA clearance and CLIA Waiver for Acucy Influenza A&B Test
9 October 2019 -

Diagnostics company Sekisui Diagnostics revealed on Tuesday that the Acucy Influenza A&B Test Class II assay has passed the US Food and Drug Administration's (FDA) 510(k) clearance as well as the CLIA Waiver for use on the Acucy Reader in either the point-of-care or laboratory setting to help improve patient outcomes, maximize clinical efficiencies and reduce operational budgets.

The company added that the Acucy Influenza A&B Test is intended for the rapid, qualitative detection of influenza A and B viral nucleoprotein antigens from both nasal and nasopharyngeal swabs. The Influenza A&B Test combined with the Reader provides clinicians with standardized and definitive result interpretation.

Upon clearance, the Acucy Influenza A&B test expands the company's flu portfolio to include all three commonly used modalities in the CLIA ((Clinical Laboratory Improvement Amendments)) Waived environment: OSOM Ultra Flu A&B Test (manual read lateral flow), Acucy Influenza A&B Test (point-of-care reader) and the Silaris Influenza A&B Test (molecular point-of-care).

Since the launch of rapid molecular tests and the 2018 FDA Flu reclassification focusing on the improved performance of on market rapid immunoassays, the clinicians are now more confident in test results and therefore better able to provide direct therapy, said the company.



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