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Opti Medical Systems COVID-19/Flu Test Nabs FDA Emergency Use Authorization

NEW YORK – Opti Medical Systems has received Emergency Use Authorization from the US Food and Drug Administration for its combination COVID-19 and influenza molecular test, according to documents posted on the FDA's website.

The Opti SARS-CoV-2/Influenza A/B RT-PCR Test simultaneously detects and differentiates between SARS-CoV-2 and influenza A/B in nasopharyngeal swabs that have been collected by a healthcare provider. It detects two different targets in the N region of SARS-CoV-2 and returns results in two hours, according to the company's website.

The test is authorized for use by high-complexity labs and has been shown to work with all known SARS-CoV-2 variants. It has also received CE marking, Opti's website said.

Roswell, Georgia-based Opti Medical Systems, a subsidiary of Idexx Laboratories, previously received EUA for its SARS-CoV-2 RT-PCR test kit in May 2020 and obtained CE marking for the test in June 2020. The firm also offers a SARS-CoV-2 antibody test and a DNA/RNA magnetic bead kit for RNA extraction.