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Classified in: Health
Subject: FDA

Sekisui Diagnostics Announces FDA Clearance and CLIA Waiver of the Acucytm Influenza A&B Test


BURLINGTON, Mass., Oct. 8, 2019 /PRNewswire/ -- Sekisui Diagnostics announces the Acucy Influenza A&B Test has received 510(k) clearance as a Class II assay from the US Food and Drug Administration (FDA), as well as, CLIA Waiver (Clinical Laboratory Improvement Amendments) for use on the Acucy Reader.

Acucy Influenza A&B Test

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 combination of the Influenza A&B Test and the Reader provides clinicians with standardized and definitive result interpretation. Utilizing the Acucy Reader in either the point-of-care or laboratory setting provides workflow flexibility with Read Now and Walk Away features.

The addition of the Acucy Influenza A&B test expands Sekisui Diagnostics flu portfolio to include all three commonly used modalities in the CLIA 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). Sekisui Diagnostics now offers options to address the varying needs of the market to help improve patient outcomes, maximize clinical efficiencies, and reduce operational budgets.

"This is a very exciting time for Sekisui Diagnostics.  The launch of the Acucy Influenza A&B Test makes us the first and only company to provide the three most commonly used flu testing methods in a CLIA Waived format.  We take great pride in listening to our customers and we understand they have different needs during flu season.  We remain committed to providing innovative, high quality testing options so they can make the right choice for their practices and patients," said Robert Schruender, President /CEO of Sekisui Diagnostics. "Accurate diagnosis of influenza is critical to minimize transmission of infection and we are proud to be able to provide sensitive and specific tools to healthcare professionals."

Testing patients provides valuable information to the clinician that can enable them to rule out other illnesses, help determine treatment and reduces the risk of prescribing unnecessary antivirals or antibiotics. Since the introduction of rapid molecular tests and the 2018 FDA Flu reclassification focusing on the improved performance of on market rapid immunoassays, clinicians are now more confident in test results and therefore better able to provide direct therapy.

About Sekisui Diagnostics:

Sekisui Diagnostics is a global diagnostics company committed to improving patients' lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network.  Product lines include clinical chemistry and coagulation systems, reagents, rapid test kits and point-of-care systems as well as enzymes and specialty bio-chemicals.

Sekisui Diagnostics Logo (PRNewsFoto/Sekisui Diagnostics) (PRNewsFoto/Sekisui Diagnostics)

SOURCE Sekisui Diagnostics


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News published on 8 october 2019 at 08:00 and distributed by: