The Rheonix COVID-19 MDx Assay has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the in vitro qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates, bronchoalveolar lavage (BAL) fluid and saliva samples from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
The Rheonix COVID-19 MDx Assay is not cleared, CLIA waived, approved, or subject to an approved investigational device exemption.
This test has been authorized by the FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
“We are thrilled to team with Rheonix, located right here in Ithaca. Their technology and expertise has enabled us to be able to provide same day results for COVID-19 testing – one of the quickest turnaround times in our region.” – Martin Stallone, President & CEO, Cayuga Health
City of Binghamton and United Health Services
Mayor Richard C. David announced that the City of Binghamton has partnered with United Health Services and Rheonix to provide same-day COVID-19 testing.
“The City identified a Southern Tier firm and cutting-edge COVID-19 virus testing technology and quickly put it to work... these testing workstations will put the community in a stronger position to re-open our economy and let residents get back to work safely.” – Binghamton Mayor Richard C. David
Automated/Easy to Use
Processes up to 24 samples with no user intervention
No bench top purification required
Ideal for small and medium-sized labs
Easy to Deploy
Can be quickly installed in critical locations of immediate need
Requires minimal training; plug and play
Fully enclosed solution minimizes sample handling and reduces the possibility of viral contamination
Ideal Local Solution
Low cost per test
Low-medium throughput (110 sample results/day) †
Enables same-day results in distributed locations:
Local health departments
Local and regional health networks
† Number of actual test results per day may vary based on individual lab practices and workflows.
Photo Credit: Nancy J. Parisi
September 19, 2022Press Release
Rheonix COVID-19™ MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva Home Collection Kit
Rheonix Laboratories, a subsidiary of Rheonix, Inc., performs COVID-19 testing in Ithaca, NY. To schedule a test, please visit www.rheonixlabs.com. For up-to-date information on COVID-19, visit the CDC General webpage: https://www.cdc.gov/COVID19.