RHEONIX COVID-19™ MDX ASSAY RECEIVES EXPANDED FDA EMERGENCY USE AUTHORIZATION TO INCLUDE SALIVA AS A SAMPLE TYPE

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:

  • Simplified sample collection process and less invasive sample collection method for patients
  • Streamlined testing workflow
  • Reduced exposure of medical personnel to potentially infected individuals
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RHEONIX COVID-19™ MDx ASSAY*

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 Only

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Instructions for Use
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EMERGENCY USE AUTHORIZATION

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.
  • Download
    AUTHORIZATION LETTER

Customer Partnerships

Cayuga Health

Cayuga Health has teamed up with Rheonix to provide same-day COVID-19 testing in Tompkins County.

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“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.

Links

“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

Key Benefits

Gear

Automated/Easy to Use

  • Fully automated
  • Processes up to 24 samples with no user intervention
  • No bench top purification required
  • Ideal for small and medium-sized labs

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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

Gauge/Meter

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
    • Rural hospitals

† Number of actual test results per day may vary based on individual lab practices and workflows.

Photo Credit: Nancy J. Parisi

Press Releases

Press Release
Roy Proujansky, M.D., and Irving Nachamkin, DrPH, Join Rheonix Board
More Press Releases

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News
Tompkins County: One million COVID tests, second best vaccination record in state – Ithaca Times
More Rheonix COVID-19 News

COVID-19 PUBLIC HEALTH RESOURCES

Rheonix COVID-19™ MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva as a Sample Type.
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