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

BioGX (Birmingham, AL, USA) has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its breakthrough direct sample addition, Xfree 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. Xfree is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready 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.

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 USD 7-12 per sample depending on its use as direct sample addition or with extracted sample.

"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," said Matthew Beckman, Ph.D., Director of Laboratory Services at GENETWORx. "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."

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