NanoEntek Obtains Export Approval for 3-Minute COVID-19 Diagnostic Kit

[Asia Economy Reporter Jang Hyowon] NanoEntek (CEO Jeong Chan-il) announced on the 21st that it has received export approval from the Korean Ministry of Food and Drug Safety for an on-site diagnostic novel coronavirus infection (COVID-19) antibody test kit that can be tested within 3 minutes at the patient's location.

The FREND COVID-19 test kit developed by NanoEntek detects IgG/IgM antibodies naturally produced in the body in response to the COVID-19 antigen. Utilizing an advanced lab-on-a-chip platform that integrates semiconductor design technology (MEMS) with bioengineering, it enables faster and more accurate testing compared to conventional diagnostic kits using typical membranes (paper filters).

The test takes 3 minutes, and recent consecutive clinical tests showed a sensitivity match of 100% in blood samples taken 8 days after infection when antibodies begin to appear, and an overall sensitivity match of 93% across all samples. Since the FREND system is a quantitative measurement device that expresses test results numerically, the COVID-19 product being launched this time is a qualitative (negative/positive) diagnostic product, but quantitative measurement values will be provided in the future according to market demand.

NanoEntek’s FREND is equipped with a Laboratory Information System (LIS) function, which automatically transmits results to effectively manage patient information without omissions and accurately monitor diseases.

A NanoEntek official stated, “As the COVID-19 pandemic has been declared and prolonged worldwide, relying solely on genetic testing conducted early in the virus outbreak will face limitations,” adding, “As the development technologies for COVID-19 related antigens and antibodies gradually stabilize, the development and performance improvement of vaccines, therapeutics, and immune diagnostic kits using related technologies will become more active.”

Currently, many countries including the United States, China, and Germany recommend antibody testing for COVID-19. The United States conducts coronavirus antibody testing, and as long as antibody testing alone is not used to solely determine infection status, sales to frontline hospitals are possible with FDA reporting and product registration without Emergency Use Authorization (EUA).

Starting with this export approval, NanoEntek plans to supply highly accurate antibody testing systems not only to major bases in the United States and Europe, which have been its main focus, but also to underdeveloped countries where large-scale genetic testing is difficult due to personnel and cost issues.

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