Le Lézard
Classified in: Health, Covid-19 virus
Subject: FDA

BioGX Receives FDA EUA for a Novel, High-Throughput, Direct Sample RT-PCR Test for COVID-19


BIRMINGHAM, Ala., July 1, 2021 /PRNewswire/ -- BioGX, a global provider of molecular diagnostic solutions, announced that the United States Food and Drug Administration has issued Emergency Use Authorization (EUA) for their breakthrough direct sample addition, Xfreetm COVID-19 test. Xfree COVID-19 is a complete test lyophilized in a single tube, for extraction-free, direct sample addition real-time RT-PCR testing.  The Xfree COVID-19 test eliminates all upfront sample processing steps and enables clinical laboratories to generate high-throughput Sample-to-Answer results using widely available real-time PCR platforms.

Matthew Beckman, Ph.D., Director of Laboratory Services at GENETWORx said, "The staff at GENETWORx has been very pleased with the performance of the BioGX Xfree COVID-19 test.  In our studies, we have determined that the BioGX Xfree test performs superior to ThermoFisher's Taqpath and Quanta's XLT-Script One-Step RT-PCR products for the SARS-CoV-2 testing as determined by head-to-head comparisons. BioGX test is very simple to use while providing increased quality assurance of well-by-well monitoring of the PCR reaction. The product also offers the consistency and platform flexibility to rapidly increase throughput without needing to invest in additional resources and new systems."

"Our test not only enables laboratories of all sizes to perform high-performance cost-effective testing, but also provides robust strain coverage for all prevalent strains, including the rapidly spreading Delta variant", said Shazi Iqbal, Ph.D., CEO of BioGX. "The FDA authorization of our Xfree chemistry paves the way for us to leverage our expansive menu of tests to create an Xfree line of point-of-care (POC) tests for respiratory and urinary tract infections", he added.    

The FDA has authorized the Xfree COVID-19 test with broad specimen coverage to include nasopharyngeal, anterior nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate and nasal aspirates. Additionally, the test is authorized to run with extracted samples offering options for the laboratory to adapt the test in any laboratory workflow. The test is already in use in several laboratories and costs $7-12 per sample depending on its use as direct sample addition or with extracted sample.   

Xfree is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Readytm format. To perform the RT-PCR test, the user simply rehydrates the lyophilized test with molecular grade water, adds a patient sample, and runs the test on a validated real-time PCR instrument. The test can be shipped anywhere in the world without refrigeration. 

Customers can request information on Xfree COVID-19 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-Readytm 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 in several countries through its Global Distribution Network. 

For more information on BioGX, please visit BioGX.com.

Sample-Ready, Just Add Water and Xfree are trademarks of BioGX, Inc.

BioGX Contact:
Robyn Martin-Schubart    
Office: +1.205.250.8055
Email: marketing@biogx.com

 

SOURCE BioGX


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