Co-Diagnostics nets European approval for its coronavirus PCR test

Novel Coronavirus SARS-CoV-2
The molecular diagnostic test searches for RNA linked to the coronavirus strain using a RT-PCR kit aimed at conserved regions in the virus’ genome, according to Co-Diagnostics. (Image: NIAID / Rocky Mountain Laboratories)

About four days after announcing the completion of its technical submissions, Co-Diagnostics said it has received European approval for its in vitro diagnostic test for the novel coronavirus, known as SARS-CoV-2.

The Salt Lake City-based developer’s Logix Smart Coronavirus COVID-19 Test is now available to be exported from Utah to countries requiring the CE Mark, according to the company.

“Co-Diagnostics has received overwhelming interest in our novel coronavirus diagnostic from all over the world since first announcing its development a month ago,” CEO Dwight Egan said in a statement.

The company also said it previously shipped research use only versions of the test to distributors in Italy and Germany earlier this month to help familiarize local users with its functionality and sensitivity.

“We look forward to scaling up production to meet global demand with this regulatory clearance in place, and to obtaining approvals from other bodies that will allow us to further increase the reach of this invaluable diagnostic tool,” Egan added.

RELATED: Co-Diagnostics receives CE mark for Zika screening test

The molecular diagnostic test searches for RNA linked to the coronavirus strain using a real-time RT-PCR kit aimed at conserved regions in the virus’ genome.

As of February 25, over 80,000 worldwide cases of the resulting respiratory disease, dubbed COVID-19, have been confirmed by international healthcare organizations. That includes 270 cases in Italy, 16 in Germany, 13 in the U.K. and 12 in France.

RELATED: FDA grants emergency nationwide use to CDC's coronavirus test

To help gear up and fuel its efforts, Co-Diagnostics quickly raised $10.2 million over a few days through a registered direct offering earlier this month, selling over 3.3 million shares in the company at $3.08 apiece. The company said it planned to use the proceeds to acquire PCR equipment and working capital for additional R&D costs.

Following the news of the CE Mark, Co-Diagnostics’ stock price jumped over 20% and currently sits at about $3.77.

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