Rheonix Inc. announces opening of new laboratory, offering a low-cost COVID-19 PCR testing program

Rheonix Laboratories LLC is a New York State-permitted CLIA laboratory that provides easy, streamlined testing for organizations and community members

ITHACA, N.Y. — Rheonix Inc., a manufacturer of a highly advanced microfluidic molecular testing platform, announced the opening of Rheonix Laboratories LLC, a CLIA-certified clinical laboratory located in Ithaca, New York. 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 (EUA) by the U.S. 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.

“Offering testing through an affiliated laboratory is an important extension of Rheonix’s core mission: to offer molecular diagnostics to more people, in more places, more often,” said Greg Galvin, President, CEO and Chairman of the Board of Directors of Rheonix. “The initial focus of Rheonix Laboratories is to provide a convenient and economical COVID-19 PCR testing option for organizations and community members. In the future, we plan to offer additional assays at the laboratory, including syndromic panels for respiratory, gastrointestinal and sexually transmitted infections.”

Since early in the pandemic, Rheonix has been a leading 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, U.S. laboratories have processed more than 1 million samples using Rheonix’s COVID-19 testing system. To learn more or schedule a COVID-19 PCR test, visit rheonixlabs.com. Organizations interested in learning more about Rheonix Laboratories’ COVID-19 Testing Program and partnership opportunities should email sales@rheonixlabs.com.

About Emergency Use Authorization Status:

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 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Rheonix Inc.:

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. For more information, visit rheonix.com.