Co-Diagnostics, Inc. Completes FDA EUA Submission for Extraction-Free Saliva COVID-19 Test
January 28, 2021 at 02:30 pm
Share
Co-Diagnostics, Inc. announced that it has completed its submission to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) of its Logix Smart™ SARS-CoV-2 DS (Direct Saliva) test, 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. 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. 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. 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.
Co-Diagnostics, Inc. is a molecular diagnostics company, which develops, manufactures and markets diagnostics technologies. The Companyâs technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR platform and to locate genetic markers for use in applications other than infectious disease. Its diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. It is developing a portable diagnostic device and test system designed for point-of-care and at-home use. The system consists of its PCR instrument that it refers to as the Co-Dx PCR Pro instrument, its proprietary diagnostic test cup system and a mobile application to be installed on the userâs mobile device.