Omicron Diagnostic Kits to Be Deployed On-Site This Month

Bioneer and Seegene Develop
KCDC Begins Validity Verification
"Many Hidden Infected Cases Expected"

On the 20th, as the spread of COVID-19 continues, citizens are taking numbered tickets to get tested at the COVID-19 screening clinic set up at Seodaemun-gu Public Health Center in Seoul. Photo by Mun Ho-nam munonam@

[Asia Economy Reporter Seo So-jung] As domestic Omicron infections surge, the Korea Disease Control and Prevention Agency (KDCA) has entered the final phase of efficacy verification for the commercialization of diagnostic kits capable of detecting the variant. With domestic companies such as Bioneer and Seegene developing kits to identify Omicron, it is expected that these kits could be applied in the field as early as next week.

According to the KDCA on the 21st, the process of reviewing the efficacy of prototype Omicron variant diagnostic kits developed by the bio and pharmaceutical industries is currently underway. Bioneer, Seegene, Atoplex, and Kozen Biotech have all completed the development of related kits. Bioneer developed a diagnostic kit capable of detecting Omicron on the 14th and 16th, and another kit that can distinguish between Omicron and Delta variants.

Bioneer expects that these two diagnostic kits will meet the urgent demand from health authorities worldwide aiming to curb the rapidly spreading Omicron variant early. A Bioneer official stated, "It is important to distinguish between Omicron and Delta variants," adding, "We are sourcing clinical specimens both domestically and internationally for CE and export approval, and plan to apply for approval immediately after clinical trials." Kozen Biotech announced on the 15th that it had completed the development of a diagnostic kit capable of detecting variants including Omicron, Alpha, Beta, Gamma, and Delta. Seegene also developed a kit on the 9th that can distinguish both Omicron and stealth Omicron variants.

The quarantine authorities are evaluating the efficacy of Omicron variant gene amplification (PCR) reagents using clinical specimens to ensure distribution to the field by the end of this month. However, verifying the accuracy of the diagnostic kits developed by companies is taking time. Professor Lee Hyuk-min of the Department of Laboratory Medicine at Severance Hospital explained, "While Omicron variant diagnostic kits can be developed in about one to two weeks, it takes time to evaluate their performance and establish a diagnostic system," adding, "It is possible to develop kits usable at the laboratory level, but to evaluate the performance of diagnostic kits and use them nationwide in diagnostic laboratories requires separate training and the establishment of a data verification process."

Experts have emphasized the need for the rapid distribution of kits capable of identifying the Omicron variant. Professor Chun Eun-mi of Ewha Mokdong Hospital said, "The cumulative number of domestic Omicron infections has increased to 227 today, but the future spread will be much faster," adding, "There are likely many hidden infections nationwide through group infections such as those in churches."

Following Europe, as the Omicron variant becomes dominant in the United States, it is expected that Omicron will rapidly spread domestically in the near future. Lee Sang-won, head of the Epidemiological Investigation and Analysis Team at the Central Disease Control Headquarters, stated the day before, "There is a possibility that Omicron will become the dominant variant in South Korea within the next one to two months," adding, "If preventive measures are thoroughly implemented, this could be slightly delayed."

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