Co-Diagnostics Inc technology to be used in FDA-authorized self-collected COVID-19 saliva test

CRL tests saliva samples by using patented CoPrimer probes developed by its partner Co-Diagnostics to detect the SARS-CoV-2 viral RNA with “high specificity”

Inc () said that its partner Clinical Reference Laboratory (CRL) has received US Food and Drug Administration (FDA) emergency use authorization for CRL Rapid Response, a saliva-based coronavirus (COVID-19) test that can be self-administered and then tested using Co-Diagnostics’ patented CoPrimer technology.

According to CRL’s announcement, Co-Diagnostics technology drives the “higher sensitivity and specificity” of the self-administered CRL Rapid Response test. CRL is one of the largest privately held clinical testing labs in the US, with dedicated facilities in North America and Europe.

Co-Diagnostics’ stock, which has been one of the hottest on Wall Street during the last three months, rose 12% to $26.9 in pre-market trading on Monday.

READ: Wainwright reiterates ‘Buy’ rating on Co-Diagnostics as US domestic coronavirus cases surge boosting testing demand

“We believe that CRL’s selection of the Co-Diagnostics platform, and their successful emergency use authorization from the FDA, speaks volumes about the quality, sensitivity, and specificity of our CoPrimer primer and probe technology,” Co-Diagnostics CEO Dwight Egan said in a statement.

“Co-Diagnostics is pleased to be a part of a testing initiative with so much potential to help people return to work, school, and normal life as quickly and safely as possible,” he added.

Co-Diagnostics’ Logix Smart test has earned emergency use authorization from the US Food and Drug Administration and a CE Mark from European regulators. It is currently available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19.

The company’s Logix Smart COVID-19 test’s high accuracy has been independently validated by PathWest Laboratories in Australia, the Indian National Institute of Pathology, and the Mexican Department of Epidemiology.

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

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