On December 3rd, HymonBio’s new test kit for detecting COVID-19, influenza A, and influenza B has received approval by the US Food and Drug Administration for pre-EUA (case number PEUA210541). It is expected to become China’s first innovative nucleic acid test kit for testing these three diseases to be approved in the USA.
With repeated waves of SARS-CoV-2, especially with the emergence of the new mutation strain Omicron, detection and control of the disease has grown more difficult. The epidemiological and clinical symptoms of COVID-19 and influenza A and B are very similar; dual transmission increases the difficulty of epidemic prevention and control. It is particularly important to detect influenza while preventing and controlling COVID-19. It is the priority of priorities to do well in differential diagnosis and timely intervention.
HymonBio, focusing on the development of innovative molecular diagnostic reagents, had successfully developed a new rapid test kit for SARS-CoV-2, certified by the US FDA EUA and EU CE, and has been repeatedly praised in the European and American markets. This time, HymonBio applied to the FDA for a SARS-CoV-2/influenza A/influenza B triplex panel, which will provide Europe and the United States with simultaneous, rapid detection of three diseases. Through one-step proprietary technology, one-time detection can quickly and accurately distinguish three viruses, so as to provide accurate information for clinics, effectively control the spread of disease, and serve global anti-epidemic efforts with Chinese technology.
Post time: Dec-07-2021