Domestic Device for 'COVID-19 Diagnosis' in 15 Minutes... FDA Approval Pending

Deputy Prime Minister and Minister of Economy and Finance Hong Nam-ki visited Aprogen, a bio-industry venture company located in Seongnam-si, Gyeonggi Province, on the 16th, and examined a mouse's knee joint under a microscope. Aprogen, which researches and produces antibody drugs and biosimilars, is the 11th unicorn company in Korea and the first in the bio sector, with 371 employees and total assets of 374.2 billion won. Deputy Prime Minister Hong visited the site following the confirmation of the "Bio-industry Innovation Policy Directions and Key Tasks" and the "Biohealth Core Regulation Improvement Plan" at the Innovation Growth Strategy Meeting held the previous day.
/Seongnam=Photo by Kang Jin-hyung aymsdream@

[Asia Economy Reporter Hwang Junho] A device capable of diagnosing the presence of antibodies for the novel coronavirus infection (COVID-19) within 15 minutes has been developed using domestic technology and is awaiting approval from the U.S. FDA. This device is expected to expand into various countries including the U.S. and South America due to its higher accuracy compared to other diagnostic devices that have received FDA emergency approval and its ability to diagnose multiple people simultaneously. The government has stepped up to encourage and support such domestic diagnostic companies.

On the 2nd, the Ministry of Science and ICT gathered representatives of domestic antibody diagnostic companies at the Korea Research Institute of Bioscience and Biotechnology (KRIBB) to share excellent antibody diagnostic technologies possessed by KRIBB’s Bio Nano Health Guard Research Group and to listen to the difficulties faced by each company.

KRIBB introduced antibody diagnostic devices from domestic companies using antigens developed by the ‘Bio Nano Health Guard Research Group.’ This device not only allows rapid testing but also secures higher accuracy than similar products that have received emergency use authorization from the U.S. FDA. Clinical test results showed a sensitivity of 94.4% and a specificity of 100%. Sensitivity refers to the accuracy of positive diagnosis among COVID-19 infected individuals, while specificity refers to the accuracy of negative diagnosis among non-infected individuals.

The company manufacturing this device has applied for emergency use authorization from the U.S. FDA. If approved, it will be the first domestic approval case for an antibody diagnostic device using the ELISA method. The ELISA method refers to a technique capable of diagnosing 46 to 96 people simultaneously.

Antibody diagnostic technology can confirm the formation of COVID-19 virus antibodies within 15 minutes, enabling quick and simple diagnosis of infection status. Since it diagnoses based on antibodies formed through immune response, it can also identify post-infection patients including asymptomatic infections.

The government is providing demand-oriented services such as establishing a technology support platform composed of government-funded research institutes and hospitals and supplying excellent antigens to support the reliability of domestic antibody diagnostic technology.

Meanwhile, at this meeting, discussions were held on advancing the corporate support methods of the technology support platform and sharing excellent antibody diagnostic technologies held by research institutions with companies.

Choi Ki-young, Minister of Science and ICT, said, "The solid scientific and technological capabilities of our country are the foundation for the successful response to COVID-19. The Ministry of Science and ICT will spare no support to develop antibody diagnostic technologies that can be utilized in various fields such as epidemiological investigations and vaccine development, and I hope company representatives will also join forces."

Minister Choi Ki-young of the Ministry of Science and ICT is delivering opening remarks at the "2nd Meeting of the Government-wide Support Group for COVID-19 Vaccine Development" held on the 8th at the Chosun Hotel in Jung-gu, Seoul. Photo by Kang Jin-hyung aymsdream@