ITHACA, N.Y. — Rheonix Inc. of Ithaca announced it has opened Rheonix Laboratories LLC, a CLIA-certified clinical laboratory that will initially offer COVID-19 PCR testing.
Rheonix is a manufacturer of a highly advanced microfluidic molecular testing platform. CLIA is short for clinical laboratory improvement amendments, which is part of the U.S. Department of Health and Human Services’ Center for Medicare and Medicaid Services (CMS).
“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,” Greg Galvin, president, CEO and chairman of the board of directors of Rheonix, said in Monday’s announcement. “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.”
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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 its populations. The laboratory’s COVID-19 PCR testing program enables seamless registration, sample collection, and testing for individuals and organizations, the company said.
Rheonix Laboratories provides “reliable, rapid” turnaround COVID-19 PCR testing utilizing the Rheonix COVID-19 MDx Assay. The U.S. Food and Drug Administration first granted the assay emergency-use authorization (EUA) 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 through the portal, Rheonix said.
Since early in the pandemic, Rheonix has provided COVID-19 testing capacity in the mid-Atlantic and northeastern U.S. The company has been providing 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, the company said.
