Forty-two Korean companies have sought regulatory approval for 64 diagnostic kits for urgent use to fight the new coronavirus (COVID-19).
However, only four products won the license after passing the review of the Ministry of Food and Drug Safety and the Korea Centers for Disease Control and Prevention (KCDC).
The ministry said Tuesday that the 42 companies sought regulatory approval for 64 detection kits for urgent use through the KCDC from Jan. 28 to Feb. 28.
Among them, the regulator has completed the review for 19 products and granted four for urgent use. Six products were inadequate due to poor function, one was unavailable for clinical performance evaluation, and eight were withdrawn by their makers voluntarily, the ministry said.
The government gave the greenlight to Kogene Biotech’s 'PowerCheckTM 2019-nCoV RT PCR kit, Seegene’s AllplexTM 2019-nCoV Assay, SolGent’s DiaPlexQTM N Coronavirus Detection kit, and SD Biosensor’s STANDARD M nCoV RT Detection kit.
The authorities were still reviewing the rest 45 test kits. The KCDC plans to evaluate the clinical performance of eight kits. Another eight needs additional data backup for review, and the rest 29 are under document review by the ministry.
Korea’s urgent use approval system temporarily authorizes the use of medical devices, including reagents, requested by the central government when the nation faces a threat of a pandemic when there is no or rare domestically approved detection kit.
The ministry, in collaboration with KCDC, gives the nod in four steps – document review the ministry, clinical performance evaluation by KCDC, expert review by the Korean Society for Laboratory Medicine, and KCDC’s approval request and the ministry’s approval.
“Domestic medical device makers manufacture the four diagnostic kits approved for urgent use,” the food and drug safety ministry said.
As of Monday, the companies manufactured 15,971 test kits for 522,770 people and supplied 11,478 kits for 381,500 people. They have 4,493 in stock for 141,270 people, the ministry said.
The ministry said it would continue to assess the products under document review. Once all the other evaluation process, including clinical performance tests and expert analysis, is complete, the government will immediately approve the test kit, it added.