Hangzhou Biotest Receives FDA EUA for COVID-19 Antigen Self-Testing Reagent

China-based Hangzhou Biotest Biotech Co., Ltd has announced receiving an Emergency Use Authorization (EUA) from the US FDA for its novel coronavirus antigen self-testing reagent. This authorization marks a significant step in expanding the availability of COVID-19 testing options in the US market.

Product Details and Usage
The COVID-19 antigen self-testing reagent is designed for qualitative detection of COVID-19 antigen in front nasal samples. It is an over-the-counter household testing product, allowing individuals to perform the test at home without the need for professional medical personnel. This self-testing option provides a convenient and accessible way for people to monitor their health status during the ongoing pandemic.

Future Prospects and Strategic Implications
The EUA from the FDA positions Hangzhou Biotest to contribute to the global efforts in combating COVID-19 by providing a reliable and user-friendly testing solution. This move underscores Biotest’s commitment to innovation and public health, as well as its dedication to meeting the growing demand for rapid and accurate diagnostic tools.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry