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Co-Diagnostics Gets CE Mark for Saliva-Based Molecular SARS-CoV-2 Test

NEW YORK — Co-Diagnostics said on Friday that it has received CE marking for its Logix Smart SARS-CoV-2 DS.

The PCR-based test is designed to detect the RdRp and E genes of SARS-CoV-2 in minimally processed saliva samples without the need for RNA extraction. The test uses the Salt Lake City-based company's CoPrimer chemistry, which involves attaching primers to probes with a polyethylene glycol-based linker to prevent the formation of primer-dimers.

"The direct saliva technical advance represents one of the important innovations that the company has developed since the [SARS-CoV-2] pandemic began," Co-Diagnostics CEO Dwight Egan said in a statement. "Direct saliva testing will play a key role in our ongoing centralized lab initiative, as well as our forthcoming at-home and point-of-care testing strategies."

SARS-CoV-2 testing has become a major part of Co-Diagnostics' business, accounting for the lion's share of the company's revenues recently.