NanoEntek Obtains European CE Certification for COVID-19 Antigen Test Kit

[Asia Economy Reporter Jang Hyowon] NanoEntek (CEO Jeong Chan-il) announced on the 9th that it has obtained the European CE-IVD certification for its COVID-19 antigen diagnostic kit (FREND COVID19 Ag), which detects antigens of the novel coronavirus infection (COVID-19).

Following the recent approval for use in Germany, obtaining the European CE certification now allows the product to be sold in a significant number of European countries.

The COVID-19 antigen diagnostic kit directly tests for antigens entering the infected person's body through droplets, enabling diagnosis even in the early stages of infection, unlike antibody tests. It is also inexpensive and easy to use since it does not require costly equipment like molecular diagnostics, leading to rapidly increasing global demand.

NanoEntek is strengthening its related product lineup to respond to the prolonged COVID-19 pandemic. Following the COVID-19 antibody diagnostic kit (FREND COVID-19 total Ab), which has already received the US FDA Emergency Use Authorization (EUA), the company has completed the FDA EUA application for its COVID-19 PCR diagnostic kit and is currently under review. Additionally, the COVID-19 antigen diagnostic kit that recently obtained European certification will soon be submitted for FDA EUA approval, aiming for approval within this year.

A NanoEntek representative stated that sales of COVID-19 diagnostic kits have been steadily increasing, and with exports to new countries including the US starting from the fourth quarter, they expect a stable upward sales trend.

This content was produced with the assistance of AI translation services.