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.

Links
Press Release »
News Coverage »

“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

Dr. Elizabeth Plocharzyk discusses the need for same-day testing at 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

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News
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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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