NEW YORK – Co-Diagnostics said on Monday afternoon that its Logix Smart Coronavirus COVID-19 test has received CE-IVD marking for the detection of SARS-CoV-2, the cause of the COVID-19 disease that originated in China and is moving toward a pandemic.
The test can now be sold as an IVD in markets that accept CE marking as valid regulatory approval, and is now available for purchase from the firm's Utah-based ISO-13485:2016-certified facility, Co-Diagnostics said.
The reverse-transcriptase quantitative PCR assay uses proprietary Co-Primer technology that the company claims could improve specificity of the test, reducing the likelihood of a false positive diagnosis. Co-Diagnostics originally disclosed it was developing its assay in mid-January.
"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," Co-Diagnostics CEO Dwight Egan said in a statement.
Co-Diagnostics' stock finished Monday trading on the Nasdaq up nearly 29 percent at $3.93.