Korean diagnostic kit manufacturers brushed off concerns that their PCR test devices could not detect Omicron, a new Covid-19 variant hitting the globe.

LabGenomics on Monday that its PCR testing product LabGun COVID-19 ExoFast RT-PCR Kit was able to identify Omicron.

Korean diagnostic device manufacturers said their products had no problem detecting the Omicron variant.
Korean diagnostic device manufacturers said their products had no problem detecting the Omicron variant.

“Our partner company Siemens, a supplier of Covid-19 diagnostic kits in India, asked us to confirm whether our product could detect Omicron, and we presented various evidence and said it was possible,” LabGenomics said.

LabGun COVID-19 ExoFast RT-PCR Kit detects the RdRp and N gene to decide on Covid-19 infection.

LabGenomics did not disclose the evidence for the product’s ability to diagnose Omicron infection.

However, Siemens Healthineers confirmed Korea Biomedical Review that it was true that LabGenomics presented the evidence to Simens Healthineers.

Seegene, another seller of a PCR test kit, also said its product did not have any issue in diagnosing Covid-19 confirmed cases.

However, the company said a more thorough investigation is needed to confirm whether a Covid-19 patient was infected with the Omicron variant.

“We are checking the possibility of distinguishing Omicron infection,” an official at Seegene said.

SD Biosensor, which sells not only rapid antigen testing kits but RT-PCR point-of-care device M10, said existing products could diagnose Covid-19 infection, including the Omicron variant.

“Our PCR testing devices and rapid antigen kits are not affected by the Omicron variant,” an official at SD Biosensor said.

SD Biosensor has been exporting M10, which reduced RT-PCR testing time, to Europe since August.

The company seeks FDA approval in the U.S. and a permit from the Ministry of Food and Drug Safety in Korea.

However, SD Biosensor noted that it had to review further whether their testing kits could distinguish the Omicron mutation from the Covid-19 virus and mutations of other variants.

“We will release the findings soon,” the official at SD Biosensor said.

The Omicron variant is known to have 50 mutations, including 32 in the spike (S) protein, whereas the Delta variant has 16 mutations in the S protein.

Korean Covid-19 test kits usually check the RdRp, E, and N sites.

Some claimed that diagnostic kit makers should develop a new PCR testing method to check the S site to respond to the Omicron variant.

Kang Ha-na, an analyst at EBEST Investment & Securities, said a detection kit exclusive for Omicron or a kit with a high reading rate for variants would be essential because the slower the mutation reading, the slower the overall prevention of the viral spread.

Diagnostic companies’ market shares of Covid-19 diagnostic kits will change depending on their products’ ability to distinguish Omicron, and how the companies will handle this issue draws particular attention.

Copyright © KBR Unauthorized reproduction, redistribution prohibited