COVID-19 PCR Test Receives FDA EUA

Birmingham, AL-based BioGX announced today it had received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Xfree COVID-19 Direct RT-PCR test.

It is an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients suspected of COVID-19.

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

"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," Shazi Iqbal, PhD, CEO of BioGX, said.

The 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).

In addition, the company says it has the ability to scale up the number of tests. "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,” Shahin Iqbal, PhD, SVP of Global Operations, said. "With efficient and early planning, we were able to secure long-term supply of critical raw materials to avoid any potential supply disruptions."

BioGX provides lyophilized real-time PCR reagents for molecular diagnostics.