Access Bio announced on the 25th that it received 510(k) approval from the U.S. Food and Drug Administration (FDA) for its combo self-diagnostic kit, 'CareSuperb COVID-19·Flu A&B Antigen Combo Home Test,' which can simultaneously diagnose COVID-19 and influenza.
This product can distinguish and diagnose COVID-19 and influenza A·B, which have similar symptoms, within 10 minutes. This allows for quick and efficient diagnosis.
The company explained that it plans to supply the product in cooperation with partners that have large retail networks in North America such as CVS, Walgreens, and Target, and to diversify its sales channels by entering the public procurement market.
An Access Bio official noted, "We expect to secure a competitive advantage based on the strengthened 'Buy American Act' and the trend of imposing tariffs on overseas manufactured goods, as we carry out the entire process from development to production and delivery within the United States. We will actively expand growth opportunities based on our production capacity in the U.S. and our global network."