BioGX COVID-19 Tests Detect Omicron SARS-CoV-2 Variant

Xfree™ COVID-19 Direct RT-PCR Test

BIRMINGHAM, Ala.–(BUSINESS WIRE)–BioGX, a global provider of molecular diagnostic solutions, announced that the Omicron (B.1.1.529), the latest emerging SARS-CoV-2 variant of concern, will be detected by the portfolio of BioGX SARS-CoV-2 products that target the nucleocapsid (N-gene) and envelope (E-gene) for detection of the virus.

BioGX’s SARS-CoV-2 surveillance program includes exhaustive in-silico analysis and experimental testing by BioGX scientists using RNA sequences containing the mutations present within the emerging SARS-CoV-2 variants. The analysis conducted by BioGX confirmed the BioGX portfolio of COVID-19 tests maintain detection coverage for all variants of interest and variants of concern, including the new Omicron variant.

BioGX offers a portfolio of COVID-19 RT-PCR tests for a variety of real-time PCR platforms, including BD MAX™ System, Applied Biosystems™ 7500 Fast Dx, Applied Biosystems™ QuantStudio™ 5, Bio-Rad CFX96 Touch™ and Bio-Rad CFX384 Touch™. Details of each test are available at BioGX.com. Within the BioGX portfolio, the Xfree™ COVID-19 Direct RT-PCR is the most popular test because of its ease-of-use and flexibility for high throughput applications. To perform the RT-PCR testing, the user simply rehydrates the lyophilized Xfree™ reagent with molecular grade water, adds the patient sample, and runs the test on a validated real-time PCR instrument. Xfree™ COVID-19 is the only lyophilized, direct sample addition, extraction-free, RT-PCR test to receive FDA emergency use authorization for a variety of widely available real-time PCR instruments and specimen types. Additionally, the test is authorized to run with extracted samples, offering options for the laboratory to adapt the test for any laboratory workflow.

Customers can request information by contacting BioGX at Ph: +1.205.250.8055 or sales@biogx.com.

About BioGX

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered in Birmingham, Alabama and Dallas, TX, and its wholly owned subsidiary BioGX B.V., based in Amsterdam, The Netherlands, (collectively “BioGX”), operates in a cGMP compliant environment certified to ISO 13485 medical device development and manufacturing standards. The proprietary Sample-Ready™ technology is at the core of all product offerings for Clinical, Food Safety, Pharma QC and Water Quality molecular testing. BioGX’s 60+ multiplex real-time PCR products are marketed and sold worldwide through its Global Distribution Network.

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 designation Pango lineage GISAID

clade 

 Nextstrain clade Spike Protein 

(a.a. changes)

 Region Initially Documented (Date) No. Sequences Analyzed 

(Date)

 N1 N2 E
Alpha B.1.1.7

Q.x

 GRY 20I (V1) 69del, 70del, 144del, (E484K**),(S494P**),N501Y, A570D, D614G, P681H, T716I, S982A, D1118H, (K1191N**) United Kingdom (SEP 2020) 417,046

(31DEC2021)

 >99% >99% >99%
Beta B.1.351

B.1.351.2

B.1.351.3

 GH/501Y.V2 20H (V2) L18F, D80A, D215G, 241del, 242del, 243del, K417N, E484K, N501Y, D614G, A701V South Africa (MAY 2020) 25,299

(31DEC2021)

 >99% >99% >99%
Gamma P.1

P.1.x

 GR/501Y.V3 20J (V3) 681H,L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, D614G, H655Y, T1027I Brazil

(NOV 2020)

 78,303

(31DEC2021)

 >99% >99% >99%
Delta B.1.617.2

AY.x

 G/478K.V1 21A, 21I, 21J 417N, T19R, (V70F**), T95I, G142D, E156-, F157-, R158G, (A222V**), (W258L**), (K417N**), L452R, T478K, D614G, P681R, D950N India

(OCT 2020)

 1,417,558

(31DEC2021)

 >99% >99% >99%
Omicron B.1.529 GR/484A 21K, 21L, 21M +R346K Multiple Countries

(NOV 2021)

 76,835

(31DEC2021)

 >99% >99% >99%

 

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

**Present in a subset of sequences.