Sangji Kyleum Subsidiary Ace Biomed Receives MFDS Export Approval for COVID-19 Antibody Test Kit

[Asia Economy Reporter Jang Hyowon] Ace Biomed, a subsidiary of Sangji Kyleum, a KOSDAQ-listed company, announced on the 31st that it has obtained export approval from the Ministry of Food and Drug Safety (MFDS) for the novel coronavirus disease (COVID-19) antibody diagnostic kit, ‘COVID-19 IgM/IgG Rapid Kit’.

Ace Biomed had previously obtained export approval in July for the COVID-19 molecular diagnostic kit ‘COVID-19 Fast Real-time RT-PCR Kit,’ developed through a collaborative system for research, development, production, and sales with Aram Biosystem. The company successfully completed clinical trials of the antibody diagnostic kit at Seoul National University Hospital and has now secured additional export approval.

A company representative stated, “Recently, the COVID-19 virus is resurging worldwide, and domestically, the government has raised social distancing in the metropolitan area to level 2.5, heightening tension once again. Under the current circumstances, the company is doing its best to strengthen its COVID-19 diagnostic kit lineup through early development of antigen diagnostic kits and to flexibly respond to global demand for COVID-19 diagnostic kits.”

Ace Biomed possesses world-class core technologies in proteomics, genomics, and useful substance separation and purification. Based on these technologies, it is a biotechnology specialist company that develops and produces immunodiagnostic reagents and infectious disease molecular diagnostic reagents.

The company holds the MFDS product approval for the liver disease diagnostic kit ‘AceGP Elisa Kit’ and has also successfully completed clinical trials for the conjunctivitis diagnostic kit ‘Denopink Eye,’ which was the first to be developed domestically, at Hallym University Dongtan Hospital and Pyeongchon Hospital. The company has completed the product approval application with the MFDS.

Meanwhile, Ace Biomed is researching and developing liver disease therapeutics as a future growth engine. The company has acquired related patents for this research and expects to enhance its domestic and international status as a biotechnology specialist company through successful progress in this research.

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