BioGX’s Pixl16 COVID-19 Test Gets CE-IVD Mark

Chicago, Ill.-based BioGX’s point-of-care COVID-19 test pixl16 has received CE-IVD mark in Europe.

The portable polymerase chain reaction (PCR) test targets three separate gene regions of the SARS-CoV-2 virus that causes COVID-19 infections, providing greater redundancy in detecting emerging variants.

The test uses the company’s Xfree direct sample PCR testing technology that is included in its COVID-19 Direct RT-PCR test which previously gained Emergency Use Authorization from the FDA.

The pixl16 test can deliver results on up to 16 samples in less than an hour, the company said.