It seems that Omicron's diagnostic reagent evaded the approval procedure after clinical trials of the Ministry of Food and Drug Safety and was directly put into the field by the Korea Centers for Disease Control and Prevention.
The Korea Centers for Disease Control and Prevention (KCDC) announced on the 24th that it has completed the development of a PCR reagent for rapid confirmation of Omicron mutations, which was promoted through public-private cooperation to strengthen monitoring of domestic mutations and local outbreaks.
The approval of diagnostic reagents from the Ministry of Food and Drug Safety is subject to clinical trials, and the Medical Device Safety Administration is in charge.
Kim Eun-jin, head of the inspection and analysis team at the Central Quarantine Countermeasures Headquarters, who announced the development of the diagnostic reagent, said to the reporters on the 24th, "In order to strengthen monitoring after the occurrence of Omicron, we developed a PCR reagent for rapid confirmation of Omicron mutation with private cooperation." The script was selected after evaluation of the effectiveness of prototypes by private developers and discussions with the advisory committee,” he said.
Team leader Kim continued, "The mutation PCR test method developed this time selected products with a target match rate of 95% or more, and the performance was good as both the negative and positive concordance rates were 100%."
Jung Eun-kyung, director of the Korea Centers for Disease Control and Prevention, said on the same day, "It took 3 to 5 days for genomic analysis to confirm Omicron after being confirmed with COVID-19, but it was shortened to within 3 to 4 hours after confirmation with the introduction of a new mutated PCR reagent."
In the announcement of maintaining the performance of the diagnostic kit for Omicron, Seegene and SD Biosensor announced that 'mutations are not affected', starting with Lab Genomics on the 29th of last month, but the basis announced by these companies is 'in silico (in silico)', a simulation in a virtual environment. -silico)' analysis is different from clinical trials.
Among them, SD Biosensor said on the 16th, “The international organization ‘FIND’ selected its product ‘M10’ as a point-of-care diagnostic device for low- and middle-income countries. announced that 'development is expected to be completed within this year'", and there were no clinical trial applications until the 24th.
Regarding the clinical cases of diagnostic reagents, Jung Yong-ik, director of the Medical Device Safety Bureau of the Ministry of Food and Drug Safety, said at a briefing at the Korea Centers for Disease Control and Prevention on September 8 last year, “The previous day (the 7th), the clinical performance test plan for one product for the simultaneous diagnosis of COVID-19 and flu was approved. "We plan to continue to support the reagent so that it can be quickly approved after clinical trials," he said.
Regarding the evaluation of Omicron, Newsis said, “As soon as the WHO designated Omicron as a major mutation on the 26th of last month, the authorities set up a private expert advisory committee composed of experts in diagnostic tests and viruses, and supported the development of reagent manufacturers with the goal of introducing it within this year. Afterwards, the results of the effectiveness evaluation of the prototypes made by the manufacturers showed that they were suitable for use in the field.”
Prime Minister Bu-gyeom Kim said at a meeting with the Korea Centers for Disease Control and Prevention on the 7th, "The top priority is to develop a test method that can quickly and professionally diagnose omicron mutations and introduce them to the field." attended at the same time.
At this meeting, the government said to the representatives of the companies, "We will try to simplify the approval process, such as validity evaluation."
The major script briefing was <K quarantine did it… Development of 'universal PCR' that can be identified within 4 hours of Omicron> Newsys titled 'Newsis' reported for the first time on the 24th.
On April 14, last year, in the early stages of Corona, the government promoted 'export to the US' and played a leading role in the company-led K quarantine, but controversy grew over 'FDA prior approval', and on September 18, Maryland (which imported 500,000 The state's largest daily newspaper, the Baltimore Sun, reported an article titled "University of Maryland Research Institute stops using highly acclaimed Korean diagnostic kits with frequent false-positive tests."
Regarding the frequent false-positive tests of diagnostic kits exported from Korea, he said, "This is due to the frequent false-positive tests at many nursing facilities around Maryland. The Baltimore campus lab conducted thousands of tests on 'Lab Gun', a diagnostic kit of 'Lab Genomics' (Korea), and as a result, it was confirmed that the diagnostic kit was no longer used."
At the time of export in April, government-affiliated media such as KTV and KBS reported that "our 'K-defense' is attracting attention all over the world", and the stock of diagnostic kits soared.