Emergency Approval Granted for Additional COVID-19 Diagnostic Kits.."Increasing Testing Capacity"

Seegene's COVID-19 diagnostic reagent granted emergency use authorization

[Asia Economy Reporter Choi Dae-yeol] The Korea Centers for Disease Control and Prevention (KCDC) Central Disease Control Headquarters announced on the 12th that it has granted emergency use authorization for one reagent product capable of diagnosing COVID-19 infection.

With this emergency use authorization, the number of reagents for diagnosing COVID-19 in Korea has increased to two. The product was developed by Seegene. At a briefing on the same day, Director Jeong Eun-kyung said, "We conducted a second evaluation of the novel coronavirus diagnostic reagent," adding, "The KCDC and the Korean Society for Laboratory Medicine jointly evaluated it, and after submitting the results to the Ministry of Food and Drug Safety for review, one additional product received emergency use authorization."

The new reagent is expected to be actively used in medical institutions starting next week. Previously, on the 4th, emergency use authorization was granted for a product made by Kogen Biotech. Emergency use authorization is a system where, in cases of infectious disease outbreaks requiring urgent diagnostic reagents but with no or insufficient approved products domestically, the Ministry of Food and Drug Safety temporarily approves reagents requested by the KCDC through an expedited process.

Currently, there are 38 large hospitals and 8 entrusted testing institutions capable of performing COVID-19 diagnostic tests. They can conduct up to approximately 5,000 tests per day. Once the new reagent is supplied to medical institutions, the testing capacity is expected to double compared to the current level.

Lee Sang-won, head of the KCDC diagnostic management team, said, "With the cooperation of the medical community and the Korean Society for Laboratory Medicine, we requested more institutions to participate, and many medical institutions have expressed willingness to join," adding, "We expect about 25 to 30 more institutions to participate, which will increase the number of diagnostic testing institutions."