April 15, 2020 -- Dental testing specialist OralDNA Labs has rolled out a polymerase chain reaction (PCR) assay for SARS-CoV-2 from its OraRisk line of salivary diagnostics.
The Eden Prairie, MN-based company plans to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) within 15 days, as required by FDA guidance. The OraRisk COVID-19 PCR test is based on the patented CoPrimer technology of Co-Diagnostics.
RNA extraction for all specimen types is performed using the PerkinElmer Chemagic MSM I automated specimen processing system, with analysis performed on the Roche LightCycler 480 II real-time PCR system.
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