• Thu. Jun 30th, 2022

BioGX Receives EUA From FDA For New 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 its revolutionary Direct Sample Addition, Xfree COVID-19 test. Xfree COVID-19 is a complete lyophilized in one tube test, for real-time RT-PCR testing without extraction and direct addition of samples. the Xfree The COVID-19 test eliminates all initial sample processing steps and enables clinical laboratories to generate high throughput sample-response results using widely available real-time PCR platforms.

Matthew Beckman, Ph.D., Director of Laboratory Services at GENETWORx said, “The staff at GENETWORx have been very satisfied with the performance of the BioGX Xfree COVID-19 assay. In our studies, the test was superior to other SARS-CoV-2. tests we evaluated in direct comparisons. The BioGX assay is very easy to use while providing increased quality assurance of well-by-well monitoring of the PCR reaction. The product also offers the consistency and flexibility of the platform to quickly increase throughput without the need to invest in additional resources and new systems. “

Our assay not only enables laboratories of all sizes to perform high-performance and cost-effective assays, but also provides robust strain coverage for all prevalent strains, including the fast-spreading Delta variant, ”said Shazi Iqbal, Ph.D., CEO of BioGX. “The FDA clearance of our Xfree chemistry paves the way for us to take advantage of our extensive menu of tests to create a Xfree range of point-of-care (POC) tests for respiratory and urinary tract infections, ”he added.

The FDA has cleared the Xfree COVID-19 test with wide sample coverage to include nasopharyngeal, anterior nasal, middle turbinate and oropharyngeal swab specimens, nasopharyngeal lavage / aspiration, and nasal aspiration. Additionally, the assay is allowed to run with extracted samples providing options for the lab to fit the assay into any lab workflow. The test is already in use in several laboratories and costs $ 7-12 per sample depending on its use in direct addition of sample or with extracted sample.

Xfree is a complete assay 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.

Customers can request information about Xfree COVID-19 by contacting BioGX at Ph: +1.205.250.8055 or [email protected].

About BioGX
BioGX is one of the world’s leading suppliers of lyophilized real-time PCR reagents for molecular diagnostics. BioGX, Inc., headquartered at Birmingham, Alabama and Dallas, Texas, and its 100% subsidiary BioGX BV, based in Amsterdam, 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 heart of all product offerings for clinical molecular testing, food safety, pharmaceutical quality control and water quality. More than 60 BioGX 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.

Ready for sample, just add water and Xfree are trademarks of BioGX, Inc.

BioGX contact:
Robyn martin schubart
Office: +1.205.250.8055
E-mail: [email protected]

SOURCE BioGX