Co-Diagnostics applies for EUA for new direct PCR test for COVID-19

Co-Diagnostics Inc.,  a Salt Lake City molecular diagnostics company, has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for its Logix Smart SARS-CoV-2 DS (direct saliva) test, a COVID-19 polymerase chain reaction (PCR) diagnostic designed to detect the presence of the virus in human saliva samples without first requiring RNA extraction of the sample.

PCR tests usually require a costly, time-consuming process intended to extract any genetic material present from the cells contained in the sample, Co-Diagnostics said. These extracted samples are then analyzed for the presence of the target pathogen using PCR technology. The new test was developed following the company’s announcement that its patented CoPrimer technology was shown to be able to consistently detect the virus directly from minimally processed saliva samples. The company believes that eliminating the extraction process has the potential to increase throughput and lower costs of COVID-19 testing, all without compromising quality or accuracy.

“Our new extraction-free saliva test has been developed as part of our ongoing commitment to providing improved COVID-19 diagnostics for high-throughput laboratory settings, using technology with additional potential point-of-care applications,” said Dwight Egan, Co-Diagnostics CEO. “We believe that this technology will help to meet the domestic and global need for high-quality COVID-19 tests that can be processed quickly and affordably, while retaining the advantages of PCR testing over other testing alternatives. It also represents a major step forward in a new generation of PCR tests that can be widely more accessible and we look forward to offering additional cutting-edge molecular diagnostic tools in the continuing battle against COVID-19 and other diseases.”