PathogenDx Gains CE Mark for COVID-19 Test

Scottsdale, Ariz.-based biotechnology company PathogenDx has received the CE mark for its DNA microarray-based DetectX-Rv test for detection of the SARS-CoV2 virus that causes COVID-19 infections.

The polymerase chain-reaction assay uses nasopharyngeal swabs and standard off-the-shelf laboratory equipment to detect the coronavirus within three hours of RNA extraction from samples.

The assay, which can test pooled samples to detect the virus in multiple samples at one time, previously received Emergency Use Authorization from the FDA.