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Co-Diagnostics completes FDA submission for Emergency Use Authorization for its Logix Smart SARS-CoV-2 DS (Direct Saliva) test

Last updated: 15:59 28 Jan 2021 GMT, First published: 15:35 28 Jan 2021 GMT

Co-Diagnostics - Co-Diagnostics Inc completes submission to US Food and Drug Administration for Emergency Use Authorization for its Logix Smart SARS-CoV-2 DS (Direct Saliva) test
The Direct Saliva test is also designed to reduce sample processing time and cost by eliminating extraction

Co-Diagnostics Inc (NASDAQ:CODX) announced Thursday that it has completed its submission to the US Food and Drug Administration for an Emergency Use Authorization for its Logix Smart SARS-CoV-2 DS (Direct Saliva) test. 

The test is a COVID-19 polymerase chain reaction (PCR) diagnostic designed to detect the presence of SARS-CoV-2 in human saliva samples without first requiring RNA extraction of the sample.

Utah-based Co-Diagnostics said its new Direct Saliva test is designed to reduce sample processing time and cost by eliminating extraction.

READ: Co-Diagnostics says unaudited 4Q revenue anticipated to be historic and surpass analyst estimates

The company noted the PCR tests usually require a costly, time-consuming process intended to extract any genetic material present from the cells contained in the sample. These extracted samples are then analyzed for the presence of the target pathogen using PCR technology.

However, Co-Diagnostics' Logix Smart SARS-CoV-2 DS test was developed following the company's announcement that its patented CoPrimer technology was shown to be able to consistently detect SARS-CoV-2, the virus that causes COVID-19, directly from minimally processed saliva samples. 

Co-Diagnostics said it 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," CEO Dwight Egan said in a statement.

"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."

Contact the author: patrick@proactiveinvestors.com

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