TNS Becomes 9th Korean COVID-19 Diagnostic Kit Producer to Win U.S. FDA Approval

The Ministry of Science and ICT announced on July 1 that the National Nanofab Center has helped TNS Co., a Korean company specializing in molecular diagnostics, develop and commercialize a COVID-19 molecular diagnosis kit that was approved by the U.S. Food and Drug Administration (FDA) for emergency use.

This diagnostic kit has two to five times more sensitivity and precision than other kits and is therefore more accurate. In particular, it has strong price and technological competitiveness as it is produced through a manufacturing process that offers a high yield.

The National Nanofab Center and TNS have worked together to improve the performance of gene-based molecular diagnostic kits and develop a mass-production technology as demand for diagnostic kits for COVID-19 has soared. The center supported TNS with its nanobio facilities, equipment and research staff, and helped shorten the development period and improve performance of the product through its modular gene amplification biochip and bio-sensor technology development platform.

With the U.S. FDA's emergency use authorization, TNS plans to start exporting the kit to the U.S., South America and the Middle East. Currently, nine Korean companies have been approved by the U.S. FDA for their COVID-19 diagnostic kits.