SEKISUI Diagnostics has received Emergency Use Authorization (EUA) for its OSOM Flu SARS-CoV-2 Combo Test.
The test is designed for the simultaneous qualitative detection and differentiation of influenzas A and B nucleoprotein antigens, as well as SARS-CoV-2 nucleocapsid antigen.
Intended for professional use and self-testing at home, the OSOM Flu SARS-CoV-2 Combo Test is a lateral flow immunochromatographic assay.
SEKISUI Diagnostics clinical research, customer care and marketing vice-president Erica Blight said: “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.”
The test is manufactured in the US. It is supported by a team of medical technologists and professionals.
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SEKISUI Diagnostics strategy and business management senior vice-president Lee Lipski said: “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.”
SEKISUI Diagnostics’ portfolio includes the OSOM and Acucy brands.
The company is also involved in the HHS/ASPR programme, which is responsible for distributing Covid Ag tests to households across the US.
Earlier this year, SEKISUI signed an exclusive distribution agreement with Aptitude Medical Systems to sell the Metrix Covid-19 test in the US market.
