ITHACA, N.Y. — 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.
About Emergency Use Authorization Status:
The Rheonix COVID-19™ MDx Assay is an endpoint RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory and saliva samples from individuals who are suspected of COVID-19 by their healthcare provider. The Rheonix COVID-19 MDx Assay has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories. This test is also authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens that are collected at home by individuals age 18 years and older (self-collected), 14 years and older (self-collected under adult supervision) or 5 years and older (collected with adult assistance) using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit, when suspected of COVID-19 by their healthcare provider. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the
duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Rheonix Inc.:
The Rheonix Encompass workstations enable highly multiplexed sample-to-answer molecular testing for use in clinical, research and applied testing laboratories. Rheonix’s clinical assays include the Rheonix COVID-19™ MDx Assay for use under FDA emergency use authorization and the STI TriPlex™ Assay for the detection of sexually transmitted infections in male urine. Applied testing solutions include the Beer SpoilerAlert™ Assay, the most comprehensive beer spoilage panel available, and the Listeria PatternAlert™ Assay, a rapid method for Listeria strain typing. For more information, visit rheonix.com.
About Rheonix Laboratories, LLC: Rheonix Laboratories, LLC, is a New York State-permitted, CLIA-compliant laboratory located in Ithaca, New York. Rheonix Laboratories is permitted by the New York State Department of Health to provide COVID-19 PCR testing and results. The laboratory’s flexible COVID-19 PCR testing program enables seamless registration, sample collection and testing for individuals and for organizations to provide low-cost testing to their populations. For more information, visit rheonixlabs.com.
