With China-originated new coronavirus (COVID-19) sweeping the entire globe, Korea’s quick and extensive testing capability is drawing the world’s attention. The nation’s remarkably fast and massive testing is attributed to the early development and release of COVID-19 testing kits by domestic in vitro diagnostics companies.
How did Korean firms build capacity to develop and roll out testing kits early, then?
According to the Korea Centers for Disease Control and Prevention (KCDC), the nation has performed 268,212 COVID-19 detection tests as of March 15, since the first report of the confirmed case on Jan. 20.
The health authorities approved four testing kits for COVID-19 for urgent use, and the nation produced 15,971 kits capable of screening 522,770 people. Among them, 11,478 kits for 381,500 people have been supplied to testing facilities and the rest, 4,493 products for 141,270 people are in stock.
Kogene Biotech, Seegene, SolGent, and SD Biosensor have won the nod for the urgent use of diagnostic reagents and kits. On March 13, BioSewoom also obtained the license for the urgent use of its product. The supply of COVID-19 diagnostic testing kits is expected to expand in Korea.
|CancerRop's Q-Sens 2019-nCoV diagnostic kit|
Lessons learned from MERS help fight COVID-19
The local in vitro diagnostics industry ascribed the swift and mega screening in just several weeks after the first confirmed case to the “urgent use approval system.” The system allows medical institutions in the private sector to use temporarily unauthorized medical supplies or diagnostic reagents for emergencies during an epidemic. The testing kits in current use obtained the license through this system.
After the outbreak of the Middle East Respiratory Syndrome (MERS) in 2015, the Ministry of Food and Drug Safety introduced the urgent use approval system for diagnostic products for high-risk, unknown infectious diseases to prevent the emergence and pandemic of new contagious diseases. After the outbreak of COVID-19 in January, the ministry prepared documents required for urgent use approval for detecting the virus, check the kits’ safety and accuracy, and granted the first green light on Feb. 4.
Some foreigners questioned Korean testing kits’ accuracy, but the government refuted the claim immediately, saying, “it was not true.”
KCDC said Korean diagnostic kits were using RT-PCR (real-time polymerase chain reaction, a method to amplify viral DNA in a patient's sample to determine the presence or absence of a virus), recognized by the World Health Organization, governments and academics around the world.
Earlier, the food and drug safety ministry received inquiries about approval procedures and review materials for COVID-19 diagnostic kits from the WHO and the International Medical Device Regulators Forum (IMDRF) and replied them back. The ministry joined IMDRF as the 10th member in 2017. IMDRF leads the world’s regulation on medical devices, and 10 IMDRF members account for 85 percent of the global medical devices market.
“In mid-January, we started to develop diagnostic reagents to prevent the coronavirus from spreading in Korea and the world. We could rapidly develop the reagent and the kit by adding our know-how to the disclosed coronavirus sequence data,” Seegene CEO Chun Jong-yoon said. “In addition to this, the urgent use approval system helped us get approval in just one week and supply the product.”
Surging global demand for Korean testing kits
As Korean companies’ mass production of rapid and accurate COVID-19 detection kits became known, they are getting order inquiries from around the world.
Seegene is reportedly receiving orders from more than 30 regions and countries, including EU, Israel, Saudi Arabia, and Thailand, and 10 among them are government requests for urgent use.
The increased demand for Korean-made COVID-19 testing kits made biotech companies rush to release related goods for exports.
Besides the five diagnostics firms that won approval for urgent use, more than 40 companies, including CancerRop, have applied for the urgent use approval of more than 60 diagnostic reagents. Most of them are likely to get the license, observers said.
Notably, CancerRop, Bioneer, Huons, LabGenomics, Sugentech, Boditech Med, and PCL are seeking to get their diagnostic reagents and kits authorized in the U.S. and Europe and export them.
Among them, CancerRop, a molecular diagnostic sequencing immunotherapy developer, has already acquired European certification as well as export approval from the food and drug safety ministry for its diagnostic kit.