RHEONIX RECEIVES FDA EMERGENCY USE AUTHORIZATION FOR AUTOMATED COVID-19 TEST

April 30, 2020

  • Sample-to-answer method will enable rapid testing in distributed locations

The Rheonix fully automated test enables detection of SARS-CoV-2, the virus that causes COVID-19. Rheonix has begun shipment of the Encompass MDx® workstation and COVID-19™ MDx assay to high-need local and regional hospital laboratories to enable them to begin testing immediately.

Read More » Contact Sales

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 respiratory samples. 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 will facilitate same-day test results for low- and medium-throughput laboratories, allowing for more rapid decisions regarding isolation and treatment of infected patients.

*Emergency Use Authorization Only

Download
Package Insert

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 respiratory 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

Four directional arrows

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
Rheonix Inc. Receives FDA Emergency Use Authorization for Rapid, Fully Automated Molecular COVID-19 Test
More Press Releases

news

News
Rapid Covid testing in North Country gets much-needed boost – The Sun Community News
More Rheonix COVID-19 News

COVID-19 PUBLIC HEALTH RESOURCES

Rheonix receives FDA Emergency Use Authorization for Automated COVID-19 Test.
Learn More