December 7, 2020
The U.S. Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19™ MDx Assay to allow the use of saliva as an approved sample type. The fully automated sample-to-answer assay was initially authorized for use on a range of respiratory specimens under EUA on April 29, 2020.
Use of saliva as a sample type enables:
The Rheonix COVID-19 MDx Assay is a fully automated test that enables detection of SARS-CoV-2, the virus that causes COVID-19, directly from nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates, bronchoalveolar lavage (BAL) fluid and saliva. The test is designed to operate on the Rheonix Encompass MDx® workstation, and requires no technician involvement after samples are loaded onto the workstation. The sample-to-answer test facilitates same-day test results allowing for more rapid decisions regarding isolation and treatment of infected patients.
*Emergency Use Authorization OnlyDownload
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.
Cayuga Health has teamed up with Rheonix to provide same-day COVID-19 testing in Tompkins County.
“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
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
† Number of actual test results per day may vary based on individual lab practices and workflows.
Photo Credit: Nancy J. Parisi