BioGX Announces FDA Emergency Use Authorization Submission of Extraction-Free Direct RT-PCR Test for COVID-19

BioGX, a molecular diagnostics solutions company, announced FDA Emergency Use Authorization (EUA) submission of an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19. 

The Xfree® COVID-19 Direct RT-PCR test ("Xfree COVID-19") is a complete test in a single vial, lyophilized in the trusted BioGX Sample-Ready™ format.  The user would simply Just Add Water™, the patient sample, and run the test on a validated real-time PCR instrument. 

"Xfree is a breakthrough in COVID-19 RT-PCR testing.  Direct addition of patient samples without any pre-processing or extraction not only overcomes critical reagents supply issues, but also significantly shortens the results turnaround time.  The fast and simple workflow is designed to help laboratories increase their testing capacity without adding expert personnel or new automation," said Shazi Iqbal, Ph.D., CEO of BioGX.   

"We believe Xfree is a game-changer.  Xfree converts the most ubiquitous real-time PCR instruments into high throughput Sample-to-Answer machines - potentially augmenting the  COVID-19 PCR testing capacity by millions," said Michael Vickery, Ph.D., EVP & CSO of BioGX. 

Xfree® COVID-19 clinical performance study by direct, extraction-free testing of 77 patient samples demonstrated 98% Positive Percent Agreement (PPA) and 100% Negative Percent Agreement (NPA) when compared to the highly sensitive extraction-based BD-BioGX SARS-CoV-2 BD MAX™ test (FDA-EUA).  Comparison with extracted viral RNA using QIAamp® DSP Viral RNA extraction kit (CDC EUA method) demonstrated 100% PPA and 100% NPA for Xfree® COVID-19.  

A single 96-well plate instrument can generate up to 1,500 test results every 24 hours, while a 384-well plate instrument can generate up to 6,000 test results.  "Our current production capacity for the Xfree COVID-19 is nearly 2 million tests per week and can readily scale to 4 million per week. With efficient and early planning, we were able to secure long-term supply of critical raw materials to avoid any potential supply disruptions," said Shahin Iqbal, Ph.D., SVP of Global Operations.

The Xfree® COVID-19 test is validated for use on QuantStudio™ 5 and CFX Touch™ real-time PCR instruments with the most common specimen types - nasopharyngeal and oropharyngeal (throat) swabs with collections in UTM, UVT, VTM and saline.  In addition to extraction-free direct testing, Xfree® COVID-19 is validated to test samples extracted with magnetic beads or silica column extraction methods. 

About BioGX

BioGX is a leading global provider of lyophilized real-time PCR reagents for molecular diagnostics.  BioGX, Inc., headquartered in Birmingham, Alabama, 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 B.V.'s 50+ molecular diagnostic products are marketed and sold in several countries through its Global Distribution Network.