Abnova Initiates COVID-19 Viral Antigen Rapid Testing in Japan and US

Neihu, Taiwan (November 4, 2020)

Abnova announced today that it has initiated the COVID-19 viral antigen rapid testing in Japan and US. Rapid viral antigen testing is critical to the tracking and containment of viral transmission while RT-PCR testing is essential for viral diagnosis. The main impediment for widespread adoption of COVID-19 viral antigen testing is the inadequate detection sensitivity. The COVID-19 resurgence and country lockdown in last few weeks have catapulted the importance of infectivity testing among schools, airports, and businesses where people gather and are in proximity to each other.

Obtaining an EUA approval from developed countries such as US, UK, Germany, or Japan has been an elusive goal for many rapid test developers and biotech companies including Taiwan. The reason has to do not only sensitivity but also false positivity issues in the rapid test and ethnic cohorts. Current antigen testing involves swabbing the nasal cavities for viral infected epithelial cells, followed by cell lysis and running the sample mixture on an immunochromatographic lateral flow strip. While the test appears simple, achieving 1ng/ml or even less than 1ng/ml sensitivity while controlling the false positivity in ethnic cohorts is a big challenge.

So far in the US, all the companies which have gained FDA EUA approval have been from US domestic companies. There is a great business opportunity for a company which can break through this entry barrier. As with influenza rapid test, COVID-19 rapid test will be utilized throughout the pandemic, resurgence, and post-vaccine era to control transmission and infectivity. An increasing market demand will persist into the future and become a routine test with widespread adoption in every country.