NanoEntek Obtains Export Approval for COVID-19 Genetic Diagnostic Kit

[Asia Economy Reporter Jang Hyowon] NanoEntek (CEO Jeong Chan-il) announced on the 10th that it has received export approval from the Korea Ministry of Food and Drug Safety for its molecular diagnostic kit for the novel coronavirus infection (COVID-19).

The product approved this time by NanoEntek uses the real-time gene amplification (Real time RT-PCR) method that amplifies specific genes of the novel coronavirus. It enhances user convenience by enabling all processes from cDNA synthesis from RNA to PCR amplification in a single tube, and it can confirm infection status within 1 hour and 30 minutes, allowing rapid large-scale testing.

With this, NanoEntek can now export not only the COVID-19 antibody diagnostic kit 'FREND COVID-19 IgG/IgM Duo' currently being exported but also the molecular diagnostic kit 'En-swer COVID-19 RT-PCR Kit,' enabling step-by-step customized responses tailored to various purposes and environments in different countries.

A NanoEntek official stated that following the antibody diagnostic kit, which is already undergoing Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), they plan to proceed with the EUA for this molecular diagnostic kit as well. They added that they will start exporting to countries such as Mexico, Indonesia, Malaysia, Russia, and Norway, where prototype testing and supply negotiations are currently underway, and will expand exports throughout the U.S., Europe, and Asia.

Meanwhile, despite stabilization of COVID-19 infections in some countries recently, the number of infections is rapidly increasing worldwide. According to the World Health Organization (WHO), on the 7th, the global daily number of infections reached 136,000 cases, marking the highest since the COVID-19 pandemic began.

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