GenCurix "NanobioLife Obtains MFDS Export Approval for COVID-19 Antigen Test Kit"

[Asia Economy Reporter Hyunseok Yoo] GenCurix announced on the 16th that its subsidiary NanobioLife has received export approval from the Korea Food and Drug Administration (KFDA) for the novel coronavirus (COVID-19) virus diagnostic kit 'NanoCareTM COVID-19 Antigen (Ag) Kit.'

The COVID-19 antigen diagnostic kit that received export approval demonstrated excellent performance with the highest level of accuracy (sensitivity 93.94%, specificity 100%) based on clinical results from renowned domestic university hospitals.

The company stated, "The export approval of the COVID-19 antigen diagnostic kit is an achievement following the European CE certification for the existing antibody diagnostic kit," adding, "NanobioLife's antigen diagnostic kit has realized the highest quality level among domestic in vitro diagnostic kit developers."

NanobioLife, a specialist in point-of-care testing (POCT) devices, is preparing for U.S. FDA Emergency Use Authorization (FDA-EUA) certification for its proprietary reader device, which is required for professional quantitative analysis of antigen and antibody diagnostic kits. Through this, the company plans to implement a leading market entry strategy in the diagnostics sector.

Kim Dong-min, Director of NanobioLife, said, "With this export approval, we can now actively export to many countries including Europe," and added, "We have already established a production system capable of handling large overseas orders and are currently exporting to six countries including the UK, Germany, the Philippines, and Indonesia."

He continued, "We will strengthen our global capabilities through joint research and marketing with GenCurix," emphasizing, "We will develop POCT and RT-PCR device products specialized in cardiovascular diseases, sepsis, and various cancer diagnostics, including in vitro diagnostic kits, to build a differentiated new growth model as an immunodiagnostics specialist."

Meanwhile, NanobioLife is an immunodiagnostic total solution company incorporated as a subsidiary after receiving investment from molecular diagnostics company GenCurix in August. In addition to in vitro diagnostic kits, it is a leading expert company in the confocal scanning reader field and develops and supplies customized readers tailored to the needs of various diagnostic companies.