SEKISUI Diagnostics Receives Emergency Use Authorization for the OSOM® Flu SARS-CoV-2 Combo Test

News provided by

Mar 05, 2024, 13:30 ET

BURLINGTON, Mass., March 5, 2024 /PRNewswire/ -- SEKISUI Diagnostics, a global medical diagnostics manufacturer, has received EUA clearance for the OSOM Flu SARS-CoV-2 Combo Test for use in professional and home testing settings.

The OSOM® Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. As with other OSOM Rapid Tests, it is made in the USA and supported by a highly skilled technical support team of medical technologists/professionals.

"The utility of detecting COVID and Flu on one test is now more important than ever having moved into the endemic phase of COVID. The OSOM test is the first antigen, visual, home test to receive EUA status, which allows us to get these diagnostic tools into the hands of healthcare providers and consumers well before the next respiratory season. This helps minimize the spread of these diseases and allows prescribing appropriate treatments once viruses start circulating.", said Lee Lipski, Sr. VP, Strategy & Business Management.

SEKISUI Diagnostics is a well-known provider of many rapid diagnostic solutions to the professional and home testing markets through a portfolio of tests under the OSOM® and Acucy® brands. They also supply COVID Ag tests through the HHS/ASPR program (COVIDTests.gov) which delivers tests for free to households across the country.

"We first entered the home testing market with our COVID-19 test as we understand these are valuable tools to reduce the spread of respiratory infections and improve the health of all people. The OSOM Flu SARS-CoV-2 Combo Test takes our offering to the next level with the ability to get two answers with one sample providing fast, actionable results to consumers as well as healthcare professionals.", said Erica Blight, VP, Clinical Research, Customer Care and Marketing.

About SEKISUI Diagnostics:

With over 40 years of experience, SEKISUI Diagnostics' mission is to provide intelligent solutions to enhance life with science and improve the health of all people.  We supply innovative medical diagnostics globally to physicians, hospitals, laboratories and alternate testing locations.   Our product lines include clinical chemistry reagents, point-of-care tests, pre-analytic systems as well as enzymes and specialty biochemicals.  

The OSOM® Flu SARS-CoV-2 Combo Test is test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation and the OSOM® Flu SARS-CoV-2 Combo Home Test is authorized for non-prescription home use with self-collected or adult-collected anterior nares nasal swab samples from individuals aged 14 years or older with signs and symptoms of SARS-CoV-2, influenza A and influenza B. The OSOM Flu SARS CoV-2 Combo Test and the OSOM Flu SARS CoV-2 Combo Home Test are only for in vitro diagnostic use under the Food and Drug Administration's Emergency Use Authorization. This product has not been FDA-cleared or approved.

OSOM® and Acucy® are registered trademarks of SEKISUI Diagnostics, LLC.

SOURCE SEKISUI DIAGNOSTICS, LLC