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 over 930,000 SARS-CoV-2 genome sequences available as of December, 2022. Sequence analysis compared the available Omicron genomes against the SARS-CoV-2 nucleocapsid (N-gene), membrane (M-gene), and RdRp coding region of the ORF1a gene (RdRp) targeted by BioGX products. In-silico analysis and empirical testing of the Omicron variants confirmed gene mutations present as of this analysis, 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. BioGX SARS-CoV-2 HMP – N1, N2 & RNase P Multiplex
3. BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX™
4. BioGX SARS-CoV-2 N1, Flu A, Flu B, RSV A/B (RUO)

 

U.S. CDC and WHO Variants of Concern Omicron Lineages*
WHO designation	Pango lineage	GISAID clade	Nextstrain clade	Emergence Location (Date)	No. Sequences Analyzed  (DEC 2022)	% Clades Detected for N1 Target
Omicron	B.1.1.529	GR/484A	21K, 21L, 21M, 22A, 22B, 22C, 22D	Multiple Countries (NOV 2021)	61,891	> 99%
Omicron Sublineages Analyzed by BioGX
Omicron sublineage			Nextstrain clade	Emergence Location (Date)	No. Sequences Analyzed  (DEC 2022)
BA.1*			21K	Southern Africa (NOV 2021)	1,716
BA.1.1*			21K	Southern Africa (NOV 2021)	3,812
BA.2*			21L	Southern Africa (NOV 2021)	5,853
BA.3*			21K	Southern Africa (NOV 2021)	0
BA.4*			22A	Southern Africa (JAN 2022)	457
BA.5*			22B	Southern Africa (JAN 2022)	1,888
XE*			N/A	UK (FEB 2022)	0
BQ.1**			22E	Nigeria (JUL 2022)	11,841
BQ.1.1**			22B	Nigeria (JUL 2022)	35,142
XBB**			22F	Multiple Countries (SEP 2022)	1,120

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

**Variants not included in CDC or WHO variant of concern list