Co Diagnostics (CODX) a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that its partner, Clinical Reference Laboratory (CRL) has received FDA Emergency Use Authorization for CRL Rapid Response™, a saliva-based COVID-19 test that can be self-administered at home, work or any other setting 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 laboratories in the U.S., with dedicated facilities in North America and Europe.
“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,” remarked Dwight Egan, CEO of Co-Diagnostics. “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.
The CE-marked and FDA EUA Co-Diagnostics Logix Smart COVID-19 test 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, in the US and many other countries.
