6 Additional Diagnostic Kits Approved for COVID-19 Detection Within 1 Hour

Cepaide's Expert Express SARS-CoV-2, which received emergency use authorization as an emergency COVID-19 diagnostic reagent

[Asia Economy Reporter Choi Dae-yeol] Six diagnostic reagent (kit) products that can determine the infection status of the novel coronavirus disease (COVID-19) within one hour have received additional approval from authorities. These kits are used when patients requiring emergency treatment or pregnant women about to give birth urgently need to know the diagnostic test results, increasing the total to nine products including three approved last month.

The Ministry of Food and Drug Safety announced on the 24th that it has additionally approved four domestic products made by Seasun Biomaterials, Micobiomed, Cosmax Pharma, and AMS, as well as two imported products applied for by Jinex and Biomerieux Korea, in response to the Korea Disease Control and Prevention Agency's emergency use approval request for COVID-19 diagnostic reagents for emergency screening purposes. The Ministry stated that after expert review of product performance and suitability for medical field use, the products were comprehensively evaluated and finally approved for emergency use. The KDCA had previously reviewed 13 products following an emergency diagnostic kit application announcement in May and approved three products last month.

The Ministry of Food and Drug Safety said, "This will help establish a rapid testing system to prevent delays in emergency treatment," and added, "We will closely cooperate to monitor the production and supply status of the approved diagnostic reagents to maintain stable supply."