Korean manufacturers of diagnostic devices are rolling up their sleeves to obtain local approval for rapid Covid-19 home test kits.
Their intense preparations came as new Seoul Mayor Oh Se-hoon and the government and the health authorities have repeatedly said they were mulling introducing at-home testing devices.
On March 18, the Ministry of Food and Drug Safety (MFDS) released the newly updated guidelines for regulatory review on approval for Covid-19 in vitro diagnostic devices, including the criteria for personal home test kits. Test kit makers are now busy adjusting their products to the new approval conditions.
Even if companies have the nod for existing diagnostic kits, they need to change the approval purpose of the products for self-testing and conduct separate clinical trials.
The MFDS reportedly said it set two conditions for approval review on self-test kits – they should have the local permit, and they have been used for home testing overseas.
Yoon Tae-ho, a senior official at the coronavirus task force, made similar remarks at a briefing on Wednesday.
“The MFDS is considering two methods for home test kits. One is to give the nod for authorized products to be used in Korea, and the other is to develop a more accurate self-test device newly,” Yoon said. He gave more weight to the former, saying it would take much more time to do the latter.
“The MFDS will release a separate guidance to grant the nod to those that have been authorized overseas to be used by the general population,” he said.
Yoon signaled that the government might allow rapid antigen tests to diversify Covid-19 testing methods to prevent the fourth outbreak of Covid-19.
Industry officials predict that Humasis, SD Biosensor, Rapigen, Genbody, and PCL are most likely to win approval for home test kits. Except for PCL, the four companies have already obtained local permission for rapid antigen test devices. Products of SD Biosensor, Humasis, and PCL are already being used for self-testing in other countries.
them, Humasis is drawing the most attention. The company’s Celltrion DiaTrust COVID-19 Rapid Test won domestic approval in March, and the product is used as a home test kit in Czech Republic, Austria, Denmark, and Sweden. After the government briefing on Wednesday, Humasis shares surged more than 20 percent. The stock price closed at 16,050 won on Wednesday, up 18.89 percent from the previous day.
Humasis won the FDA’s emergency use approval for the Celltrion DiaTrust COVID-19 Rapid Test on Friday. The company has completed trials of the product for self-testing and is waiting for the FDA’s review results.
The company is also preparing to get the Korean license for the home test kit.
SD Biosensor is conducting clinical studies to win the local permit for two self-test devices -- STANDARD Q COVID-19 Ag Home Test and STANDARD i-Q COVID-19 Ag Home Test.
STANDARD Q COVID-19 Ag Home Test obtained export approval from the MFDS on Friday.
The product’s label states that an individual can use it with respiratory infection symptoms as an auxiliary to detect SARS-CoV-2 antigen (nucleocapsid protein) through immunochromatographic assay (ICA) in a nasal smear specimen.
Rapigen, which obtained the permit for rapid antigen test device BIOCREDIT COVID-19 Ag in March, has completed overseas trials of the home test kit. The company is soon to apply for the local license.
“We’re in close discussion with the MFDS for domestic approval,” an official at Rapigen said.
Genbody is focusing on winning the license for its home test kit in other countries, just like Rapigen.
“The trend of the Covid-19 diagnostic kit industry is indeed moving toward self-testing,” an official at Genbody said. “If the Korean government opens the possibility of introducing self-test kits, Genbody will participate in this.”
PCL has yet to earn local approval, but its rapid antigen test kit PCL COVID19 Ag Gold is actively used as a self-test kit in other countries, including Austria, Pakistan, and Germany.
“We have already accumulated all the clinical data required for home testing. If the regulator opens the approval process, we can apply for it immediately,” an official at PCL said.