BioGX Omicron Variant Update

On November 26, 2021 and November 30, 2021, the WHO and the United States government SARS-CoV-2 Interagency Group (SIG), respectively, designated Omicron (SARS-CoV-2 variant B.1.1.529) as the newest variant of concern. On December 1, 2021 the first confirmed US case of Omicron coronavirus variant was detected in California. 


BioGX continuously monitors the evolution of COVID-19 variants to ensure our market leading SARS-CoV-2 RT-PCR tests will continue to detect emerging variants without impacting performance. 


BioGX has completed in-silico analysis of the 219 Omicron genome sequences available as of November 30, 2021. Sequence analysis compared the available Omicron genomes against the SARS-CoV-2 nucleocapsid (N-gene) and envelope (E-gene) , targeted by BioGX products. In-silico analysis and empirical testing of the Omicron variant confirmed the gene mutations will not affect the performance of the BioGX portfolio of SARS-CoV-2 products.


BioGX portfolio of SARS-CoV-2 products

  1. BioGX Xfree™ COVID-19 Direct RT-PCR – FDA EUA
  2. BD BioGX SARS-CoV-2 Reagents for BD MAX™ System 
  3. BioGX SARS-CoV-2 HMP – N1, N2 & RNase P Multiplex 
  4. BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX™
  5. BioGX SARS-CoV-2 N1, N2, E-gene (RUO)
  6. BioGX SARS-CoV-2 N1, Flu A, Flu B, RSV A/B (RUO)


U.S. CDC and WHO Variants of Concern* % Clades detected by targets
WHO designationPango lineageGISAID


Nextstrain cladeSpike Protein 

(a.a. changes)

Region Initially Documented (Date)No. Sequences Analyzed 




GRY20I (V1)69del, 70del, 144del, (E484K**),(S494P**),N501Y, A570D, D614G, P681H, T716I, S982A, D1118H, (K1191N**)United Kingdom (SEP 2020)417,046





GH/501Y.V220H (V2)L18F, D80A, D215G, 241del, 242del, 243del, K417N, E484K, N501Y, D614G, A701VSouth Africa (MAY 2020)25,299




GR/501Y.V320J (V3)681H,L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, D614G, H655Y, T1027IBrazil

(NOV 2020)





G/478K.V121A, 21I, 21J417N, T19R, (V70F**), T95I, G142D, E156-, F157-, R158G, (A222V**), (W258L**), (K417N**), L452R, T478K, D614G, P681R, D950NIndia

(OCT 2020)



OmicronB.1.529GR/484A21K, 21L, 21M+R346KMultiple Countries

(NOV 2021)





*Variants of concern being monitored by US CDC and WHO. 

**Present in a subset of sequences.