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BioGX Gets CE-IVD Mark for Multigene POC COVID-19 Test

NEW YORK – BioGX said on Wednesday that it has obtained CE-IVD marking for a point-of-care, multiplex RT-PCR SARS-CoV-2 assay.

The test targets the N1, RdRp, and M gene regions of the virus and uses the firm's Xfree direct-from-sample chemistries.

It runs on BioGX's Pixl platform, a portable, 4-channel, 16-well real-time PCR platform that offers turnaround times of less than an hour for up to 16 samples.

The Pixl system also features integrated results interpretation and reporting, as well as a touchpad-based interface, BioGX said. Testing requires one drop of sample added directly to the freeze-dried Xfree chemistries.

"Pixl combined with our unique Xfree chemistry offers our customers the ease-of-use and affordability of antigen-based testing with the superior sensitivity and specificity of real-time PCR testing," Shazi Iqbal, CEO of BioGX, said in a statement.

Headquartered in Birmingham, Alabama, and Dallas, with an international subsidiary in Amsterdam, BioGX obtained CE-IVD marking for a combination SARS-CoV-2, influenza A and B, and respiratory syncytial virus test two years ago. It also signed an agreement with Cepheid last month to develop a monkeypox assay.

BioGX said it is also developing a pipeline of Xfree-Pixl tests that will enable simple and affordable POC PCR testing.