BioGX announces FDA EUA submission of extraction-free direct RT-PCR test for COVID-19

Oct. 16, 2020

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, according to a press release.

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 add water, the patient sample, and run the test on a validated real-time PCR instrument.

Xfree COVID-19 clinical performance study by direct, extraction-free testing of 77 patient samples demonstrated 98 percent Positive Percent Agreement (PPA) and 100 percent 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 percent PPA and 100 percent 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, PhD, 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.

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