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, 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.

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, the test performed superior to other SARS-CoV-2 tests we evaluated in 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-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.