SD Biosensor Confirms Effectiveness of COVID-19 Variant 'Omicron' Testing

by Ryu Hyunseok

Published 30 Nov.2021 10:04(KST)

[Asia Economy Reporter Hyunseok Yoo] Global in vitro diagnostics specialist SD Biosensor announced on the 30th that, based on internal evaluations, its products are not affected by the COVID-19 variant virus ‘Omicron’.

According to SD Biosensor's internal evaluation, ▲ the COVID-19 antigen rapid test kits (product names: STANDARD™ Q COVID-19 Ag Test, STANDARD™ Q COVID-19 Ag Home Test), which can detect the presence of COVID-19 antigens within 15 minutes, and ▲ the molecular diagnostic reagent used for COVID-19 confirmation testing at screening clinics (product name: STANDARD M nCoV Real-Time-Detection kit) were confirmed to be unaffected by all existing COVID-19 variant viruses, including Omicron.

Omicron (Pango lineage B.1.1.529) is the fifth virus designated as a ‘variant of concern’ by the World Health Organization (WHO), following Alpha, Beta, Gamma, and Delta. A ‘variant of concern’ is designated when there is evidence of increased transmissibility, severity, or reduced vaccine and treatment efficacy. Omicron is expected to have higher transmissibility than Delta, which had 16 mutations, as it includes approximately 32 spike protein mutations.

SD Biosensor conducted in-silico analysis to prove that its COVID-19 diagnostic products are not affected by variant COVID viruses. The analysis confirmed that the mutated regions of Omicron do not overlap with the target regions of SD Biosensor’s COVID-19 diagnostic products. This demonstrated that the STANDARD M products (targeting ORF1ab and E gene) and STANDARD Q products are unaffected by Omicron mutations in terms of diagnostic validity and sensitivity.

Lee Hyogeun, CEO of SD Biosensor, said, “It is very unfortunate that a new variant of concern has emerged as the world gradually recovers daily life and moves toward With-Corona.” He added, “SD Biosensor will continue to strive to help end COVID-19 quickly through products with excellent sensitivity and specificity.”

SD Biosensor is a company that provides a total in vitro diagnostics platform capable of screening tests to confirmation tests. As of October 2021, SD Biosensor’s molecular diagnostic reagents for COVID-19, recognized for their quality, have reached a cumulative total of 25 million tests, and its COVID-19 antigen rapid test kits, the first in the world to obtain WHO EUL, have achieved 900 million tests as of October 2021, recording high sales in the global market.

Meanwhile, SD Biosensor has been successfully exporting the on-site molecular diagnostic device M10, which can confirm results within 30 to 60 minutes, since its launch in the European market last August, and is preparing for its launch in the domestic market.