Sekisui Diagnostics Announces FDA Clearance and CLIA Waiver of the OSOM® Ultra Plus Flu A&B Test
BURLINGTON, Mass., June 9, 2020 /PRNewswire/ -- Sekisui Diagnostics announces it has received US Food and Drug Administration (FDA) 510(k) clearance and CLIA Waiver for the OSOM® Ultra Plus Flu A&B Test.
The test utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument. It is intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.
"The clearance of the OSOM® Ultra Plus Flu A&B Test heightens the performance of our flu portfolio allowing us to provide a more accurate rapid influenza test kit to many different institutions including nursing homes, chronic care facilities, and hospitals which the CDC acknowledges is useful for public health purposes to detect influenza outbreaks," said Robert Schruender, President and CEO of Sekisui Diagnostics. "Accurate diagnosis of influenza is critical to rule in or rule out the flu and can help guide healthcare professionals when trying to diagnose other respiratory infections. This is especially important in our current situation where SARS-CoV-2 Tests are not widely available. We are proud to be able to provide another diagnostic tool which can help protect patients and our communities."
Sekisui Diagnostics offers all three commonly used modalities in the CLIA Waived environment via four different tests: OSOM® Ultra Plus Flu A&B Test (lateral flow dipstick), OSOM® Ultra Flu A&B Test (lateral flow cartridge) Acucy(TM) Influenza A&B Test (point-of-care reader) and the Silaris® Influenza A&B Test (molecular point-of-care). Sekisui Diagnostics offers more options to address the varying needs of customers to help improve patient outcomes, maximize clinical efficiencies, and reduce operational budgets. "Reflecting on the unprecedented respiratory season this year, we have seen the value of tests that can respond to high volume clinical demand no matter where testing occurs," said David Morris, PhD, Sr. Product Manager. "Rapid, point-of-care testing continues to be an essential tool in the healthcare system's ability to respond to surges in testing demand and to reduce the spread of respiratory infections."
Testing patients provides valuable information to clinicians that enables treatment decisions and reduces the risk of prescribing unnecessary antivirals, antibiotics or allows them to be referred on for more extensive testing if needed.
About Sekisui Diagnostics:
Sekisui Diagnostics is a global diagnostics company committed to improving patient's 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.
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SOURCE Sekisui Diagnostics
