Company Product Description Indication Status
Access Genetics LLC (dba OralDNA Labs), of Eden Prairie, Minn. Orarisk COVID-19 RT-PCR test Molecular diagnostic that uses Co-Diagnostics' Logix Smart COVID-19 kit For the qualitative detection of nucleic acid from SARS-CoV-2 Received amended emergency use authorization from the U.S. FDA to allow testing from a saline oral rinse collection; was previously authorized for use with swab specimens
Dascena Inc., of Oakland, Calif. Coviage Hemodynamic Instability and Respiratory Decompensation Prediction system Machine learning algorithm that analyzes patient data from electronic health records systems For adult patients with confirmed COVID-19 to assist with the early identification of patients likely to experience hemodynamic instability or respiratory decompensation Received emergency use authorization from the U.S. FDA
Laboratory Corp. of America Holdings (Labcorp), of Burlington, N.C. Heat extraction scientific testing method and technology High-throughput method for RT-PCR tests that uses heat extraction; traps viral particles, eliminating the need for RNA extraction reagents to capture and concentrate viral nucleic acid For extracting RNA from samples collected for COVID-19 molecular testing Received emergency use authorization from the U.S. FDA

Notes

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