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

Rhea-AI Summary

BioGX announced that its SARS-CoV-2 diagnostic portfolio can detect the Omicron variant (B.1.1.529). The surveillance program includes in-silico analyses confirming detection across all variants of interest. BioGX's COVID-19 RT-PCR tests are compatible with several real-time PCR platforms, notably the Xfree COVID-19 Direct RT-PCR, which is FDA authorized for multiple specimen types. This test offers extraction-free options, enhancing workflow efficiency. BioGX operates under ISO 13485 standards, providing over 60 multiplex real-time PCR products worldwide.

Positive

• BioGX's portfolio effectively detects the Omicron variant, ensuring reliability amid emerging variants.
• The Xfree COVID-19 test's FDA authorization enhances market competitiveness and laboratory flexibility.
• Extensive product compatibility with leading PCR platforms potentially increases customer adoption.

Negative

• None.

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.

For more information on BioGX, please visit BioGX.com.
Sample-Ready, Just Add Water and Xfree are registered or pending trademarks of BioGX, Inc.
BD MAX trademarks are property of Becton, Dickinson and Company (NYSE: BDX)
QuantStudio 5 and 7500 Fast Dx are trademarks of Thermo Fisher Scientific (NYSE: TMO)
Bio-Rad CFX96 Touch and Bio-Rad CFX384 Touch are trademarks of Bio-Rad Laboratories, Inc. (NYSE: BIO)

View source version on businesswire.com: https://www.businesswire.com/news/home/20211206005557/en/

Mohammed Merchant

mohammed.merchant@biogx.com

Source: BioGX

FAQ

How does BioGX's portfolio handle the Omicron variant detection?

BioGX's portfolio can detect the Omicron variant, confirmed by in-silico analyses and experimental testing.

What PCR platforms are compatible with BioGX's COVID-19 tests?

BioGX's tests are compatible with platforms like BD MAX™, Applied Biosystems™ 7500 Fast Dx, and Bio-Rad CFX96 Touch™.

What is the significance of the Xfree COVID-19 test from BioGX?

The Xfree test is FDA authorized for direct sample addition and extraction-free testing, enhancing laboratory efficiency.

What quality standards does BioGX comply with?

BioGX operates in a cGMP compliant environment and is certified to ISO 13485 medical device standards.

How many multiplex real-time PCR products does BioGX offer?

BioGX offers over 60 multiplex real-time PCR products for various applications.