SLS Bio Obtains MFDS Export Approval for COVID-19 Diagnostic Kit

[Asia Economy Reporter Kum Boryeong] SLS Bio has received export approval from the Ministry of Food and Drug Safety for its COVID-19 antibody diagnostic kit.

SLS Bio announced on the 22nd that it obtained export approval from the Ministry of Food and Drug Safety for its COVID-19 antibody diagnostic kit.

The product that received export approval this time is the 'SsmarTest COVID-19 IgG/IgM detection kit.' It uses immunoassay methods to test for the presence of COVID-19 specific antibodies (IgM/IgG) in human blood.

An SLS Bio official stated, "Test results on blood samples from symptomatic patients showed over 90% accuracy for both positive and negative COVID-19 cases. Notably, it can diagnose patients in the latent stage who are asymptomatic or pre-symptomatic, and it is suitable for mass testing of patients more than five days after infection." He added, "We plan to proceed with overseas certifications such as the European CE medical device certification and U.S. FDA product registration, and to actively pursue global market entry and product commercialization."

Meanwhile, SLS Bio is pursuing a backdoor listing, having submitted a preliminary review request for KOSDAQ listing last month. Its main businesses include pharmaceutical quality control, new drug development support, in vitro diagnostic platforms and medical devices, and development of anti-inflammatory and anti-tumor new drugs.

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