HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
MFDS said on March 10 that the kits that won approvals from both itself and the Korea Centers for Disease Control and Prevention (KCDCP) were developed by domestic molecular diagnostics specialists Seegene Inc., Kogene Biotech Co. Ltd., Sd Biosensor Inc. and Solgent Co.
The quartet were among 42 companies that sought approval for a total of 64 detection kits through KCDCP from Jan. 28 to Feb. 28. Applications were not accepted after that cut-off date.
Out of the 64 kits submitted for approval, MFDS completed checks on 19, or about 30%. The above four were approved, six were rejected due to poor functioning, eight were withdrawn and one was unavailable for testing. There are 45 kits still under review, with 29 under document review, eight waiting for clinical evaluations, and another eight requiring additional data.
One of the applicants still waiting for the ministry to complete its review of documents, Gencurix Inc., has not been idle during its wait. It signed a memorandum of understanding (MOU) with health care group Huons on March 11 for overseas distribution of its Genepro COVID-19 Detection Test worldwide. A Gencurix spokeswoman told BioWorld that CE-IVD approval has been granted, opening markets for the company in Europe, Southeast Asia, Oceania and the Middle East.
Although it could not be determined how quickly these kits would be approved, the source said that they are being reviewed in order of submission.
The approval comes on the heels of Hong Kong’s University of Science and Technology (HKUST) claims to have developed the fastest known COVID-19 diagnostic kit. The kit can diagnose the virus in 40 minutes.
Under the normal process, approval for a medical device can take between eight months to one year, as the source pointed out that the technical documents and lab results required take time to prepare. However, under urgent-use approval this time frame is shortened to one to two months.
The urgent-use approval process is only requested by the government if the medical device required to fight a pandemic is rare or does not exist. MDFS and KCDCP then follow a four-step approval process that includes documents review, clinical performance evaluation, Korean Society for Laboratory Medicine review and MDFS approval at KCDCP’s request.
Kogene Biotech’s Powercheck 2019-nCoV RT PCR kit was the first to be approved on Feb. 4. The kit is able detect the E gene and the RdRP gene strains of the virus, with experience gained during the MERS-CoV outbreak in 2015 used to speed up development and production.
Seegene’s Allplex 2019-nCOV Assay received its approval on Feb. 12. It said it is the only detection kit currently able to detect the E gene, RdRP gene and N gene, the current three COVID-19 target genes. The kit can perform 1,000 tests simultaneously and deliver the diagnosis in less than four hours.
Solgent’s DiaplexQ N Coronavirus Detection kit was approved on Feb. 27. It detects the E gene and the RdRP gene strains of the virus with diagnosis taking less than two hours.
Sd Biosensor’s Standard M nCoV RT Detection kit was also approved on Feb. 27. It also detects the E gene and the RdRP gene strains.
The four approved devices are currently being used to diagnose COVID-19 cases throughout the country.
As of March 9, 15,971 kits to perform 522,770 tests have been produced and of these 11,478 kits have made their way to 381,500 patients. The companies have left 4,493 kits to test 141,270 people as backup stock. One kit can perform between 25 to 50 tests.
The first outbreak of COVID-19 in South Korea emerged in the southern city of Daegu a month after the coronavirus surfaced in Wuhan, China. WHO Director-General Tedros Adhanom Ghebreyesus declared COVID-19 a pandemic on March 11.
As of March 15, the WHO recorded 153,517 cases globally, including 10,982 new cases, and 5,735 deaths. South Korea has reported 8,162 cases.