BioGX Ships First Batch of pixl™ Real-Time PCR Platform to US Laboratories

BIRMINGHAM, Ala., February 28, 2023 (Newswire.com) – BioGX, a global provider of easy molecular diagnostic solutions since 2007, has announced fulfillment of multiple initial orders for its portable pixl™ real-time PCR platform to customers across the U.S., with immediate plans to scale production to meet market demand.

“We’re very impressed with the response to the launch of our novel ‘pixl’ qPCR platform. Pixl is accelerating validation and adoption of our vast multiplex RUO syndromic panels available in our unique Xfree and Sample-Ready lyophilized formats,” said Shazi Iqbal, Ph.D., BioGX CEO.

The pixl instrument is a compact, 4-channel, 16-well, real-time-PCR instrument that supports rapid turnaround times for batches of up to 16 samples, with integrated results analysis. Previously, in 2022, the US FDA authorized the pixl platform use with the BioGX Xfree COVID-19 Direct RT-PCR EUA test.

BioGX offers an extensive menu of RUO lyophilized multiplex syndromic panels for laboratory validation on the pixl platform, including the extraction-free Direct-Sample-to-Answer assays: Xfree Human Monkeypox (hMPXV), Xfree HSV1/HSV2/VZV and Xfree Treponema pallidum (Syphilis). The Xfree assay format is compatible with most transport/collection media types and can be validated for a wide variety of clinical sample collections.

View Original Press Release at:

https://www.newswire.com/news/biogx-ships-first-batch-of-pixl-real-time-pcr-platform-to-us-21969098

Jan 2023 Update: BioGX in silico analysis of SARS-CoV-2 Variants of Concern

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 designationPango lineageGISAID
clade 		Nextstrain cladeEmergence Location (Date)No. Sequences Analyzed 

(DEC 2022)

% Clades Detected for

N1 Target

OmicronB.1.1.529GR/484A21K, 21L, 21M, 22A, 22B, 22C, 22DMultiple Countries (NOV 2021)61,891> 99%

Omicron Sublineages Analyzed by BioGX

Omicron sublineageNextstrain cladeEmergence Location (Date)No. Sequences Analyzed 

(DEC 2022)

BA.1*21KSouthern Africa (NOV 2021)1,716
BA.1.1*21KSouthern Africa (NOV 2021)3,812
BA.2*21LSouthern Africa (NOV 2021)5,853
BA.3*21KSouthern Africa (NOV 2021)0
BA.4*22ASouthern Africa (JAN 2022)457
BA.5*22BSouthern Africa (JAN 2022)1,888
XE*N/AUK (FEB 2022)0
BQ.1**22ENigeria (JUL 2022)11,841
BQ.1.1**22B Nigeria (JUL 2022)35,142
XBB**22FMultiple 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