World’s Simplest High-Throughput RT-PCR Test for COVID-19 Could Increase Testing Capacity by Millions per Week

An extraction-free, direct sample addition RT-PCR test for the detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19 has the potential to increase testing capacity by millions per week.

BioGX Inc. (Birmingham, AL, USA) has applied for Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) for its extraction-free, direct sample addition RT-PCR test for the detection of SARS-CoV-2 viral RNA in suspected COVID-19 patients. The Xfree COVID-19 Direct RT-PCR test 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.

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. 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 is also the world’s first COVID-19 test that does not require refrigeration.

In a study of its clinical performance by direct, extraction-free testing of 77 patient samples, the Xfree COVID-19 test 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). A 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.

“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.

“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.

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