Research & Development
Rheonix Opens New Laboratory Offering a Low-Cost COVID-19 PCR Testing Programme
29 July 2022 - - New York-based microfluidic molecular testing platform manufacturer Rheonix Inc has opened Rheonix Laboratories LLC, a CLIA-certified clinical laboratory located in Ithaca, New York, the company said.

Rheonix Laboratories is permitted by New York State to provide COVID-19 PCR testing and results, and will be partnering with organizations, including pharmacies, schools, long-term care facilities and county and municipal health departments, to provide low-cost testing to their populations.

The laboratory's flexible COVID-19 PCR testing program enables seamless registration, sample collection and testing for individuals and organizations.

Rheonix Laboratories provides reliable, rapid turnaround COVID-19 PCR testing utilizing the Rheonix COVID-19 MDx Assay, which was first granted emergency use authorization by the US Food and Drug Administration in April 2020.

The assay is highly sensitive and detects all COVID-19 variants of concern, including the Omicron subvariants. Individuals can register online for a test using the Rheonix Laboratories Patient Portal.

Sample types include saliva and nasal swabs. Results are expected within 24 hours after receipt of sample and can be viewed conveniently and securely through the portal.

Since early in the pandemic, Rheonix has been a provider of COVID-19 testing capacity in the mid-Atlantic and Northeastern United States.

The company has been instrumental in providing easily scalable COVID-19 PCR testing capacity to community hospitals and local clinical laboratories, reducing turnaround time from two weeks to same day.

Since April 2020, US laboratories have processed more than 1 m samples using Rheonix's COVID-19 testing system.

The Rheonix COVID-19 MDx Assay is an endpoint RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory and saliva samples from individuals who are suspected of COVID-19 by their healthcare provider.

The Rheonix COVID-19 MDx Assay has not been FDA cleared or approved. 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 is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b) (1) of the Act, 21 USC. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.

The Rheonix Encompass workstations enable highly multiplexed sample-to-answer molecular testing for use in clinical, research and applied testing laboratories.

Rheonix's clinical assays include the Rheonix COVID-19 MDx Assay for use under FDA emergency use authorization and the STI TriPlex Assay for the detection of sexually transmitted infections in male urine.

Applied testing solutions include the Beer SpoilerAlert Assay, the most comprehensive beer spoilage panel available, and the Listeria PatternAlert Assay, a rapid method for Listeria strain typing.
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