Precision Biosensor said its U.S. subsidiary, Nano-Ditech Corp., has received emergency use authorization (EUA) from the U.S. FDA for its dual diagnostic kit, Nano-Check Influenza+COVID-19 Dual Test.

The diagnostic kit is a rapid diagnostic product designed to simultaneously detect Covid-19 and Influenza A and B. It enables visual confirmation of infection from nasal samples within 15 minutes, with the recommendation to conduct at least two tests over three days, spaced 48 hours apart.

According to the U.S. Centers for Disease Control and Prevention (CDC), Covid-19 and influenza share similar symptoms, making accurate diagnosis crucial for appropriate treatment.

Individuals infected with both viruses tend to experience more severe illnesses compared to those infected with only one, which has led the FDA to continue granting EUA for dual diagnostic products.

“With the EUA approval of the Nano-Check Influenza+COVID-19 Dual Test and the pending FDA 510(k) application for our respiratory syncytial virus (RSV) test, we are well-positioned to meet diagnostic demands during the high respiratory infection season this fall,” Precision Biosensor CEO Kim Han-shin said. “Precision Bio will continue to expand its portfolio of respiratory infection diagnostic products to strengthen Nanoditec's presence in the North American diagnostic market.”