Rheonix Inc. announced today that the United States Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19 MDx Assay to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit. Rheonix’s fully automated sample-to-answer COVID-19 assay received its initial EUA for use on a range of respiratory specimens on April 29, 2020. The EUA has subsequently been expanded to include use of saliva as a sample type and use by both moderate and high complexity laboratories.
Initially, the Rheonix COVID-19 saliva home collection kit will be made available for use through Rheonix Laboratories, LLC, a New York State-permitted CLIA-compliant clinical laboratory located in Ithaca, New York. Rheonix plans to expand use of the home collection kit through partnerships with additional authorized laboratories.
“The addition of a home collection kit expands individuals’ access to a low-cost, highly sensitive COVID PCR test,” said Greg Galvin, President, CEO and Chairman of the Board of Directors of Rheonix. “We have confirmed our test’s ability to reliably detect the omicron subvariants, including BA.5. This is critical at a time when home antigen tests have been shown to be much less effective at detecting this highly infectious subvariant.”
Since early in the pandemic, Rheonix has been a leading provider of COVID-19 testing capacity in the eastern U.S. The company has been instrumental in providing easily scalable COVID-19 PCR testing capacity to community hospitals and local clinical laboratories, reducing turnaround time from two weeks to same day. Since April 2020, U.S. laboratories have processed more than 1 million samples using Rheonix’s COVID-19 testing system.
Source: Company Press Release
