OSANG Healthcare's new COVID-19 and influenza (flu) combo kit received approval from the U.S. Food and Drug Administration (FDA), clearing the way for its sale in the United States. This diagnostic device can simultaneously determine the infection status of COVID-19 and influenza types A and B.
OSANG Healthcare noted on the 14th that its personal and professional COVID-19 and flu combo kit received official FDA approval (510(k)) about 10 months after receiving emergency use authorization in March of last year.
It is the world's first FDA 510(k) approval among personal and professional combo rapid test products. The company emphasized that this official approval provides a foothold to target not only the professional market such as testing and medical institutions in the U.S. but also the consumer market through pharmacies and supermarkets, as well as the procurement market for government agencies. From a corporate perspective, the official approval offers advantages in sales and marketing compared to emergency use authorization.
The company will begin full production this month to quickly supply products to the U.S. market. According to the U.S. Centers for Disease Control and Prevention (CDC), at least 9.1 million flu cases were reported in the United States during the first week of January. Not only in the United States but also globally, respiratory diseases such as COVID-19, flu, respiratory syncytial virus (RSV), and human metapneumovirus (HMPV) are rampant in countries like China and India. Previously, OSANG Healthcare supplied 100 million COVID-19 test kits to the United States in 2023.
A company official said, “I cannot disclose specific details due to the confidentiality request from the ordering party, but a multi-year supply contract was already signed last year,” adding, “Following the official approval, discussions with the ordering party were held to launch in the U.S. market, and we plan to enter full production in January to quickly supply products.”
He noted, “OSANG Healthcare's diagnostic kit products have been recognized for their technological prowess by being selected twice in a row for the Independent Test Assessment Program (ITAP) under the National Institutes of Health (NIH),” adding, “We are also developing follow-up respiratory disease products as well as mosquito-borne disease products such as dengue fever.”
Meanwhile, OSANG Healthcare, founded in 1996, is engaged in biochemical diagnostic, molecular diagnostic, and immunodiagnostic fields. It went public on the KOSDAQ market in March 2024 and is currently dedicated to developing new products such as continuous glucose monitoring systems (CGMS) and photothermal-based point-of-care molecular diagnostic devices (POC-MDX).