ITHACA, N.Y.—Ithaca-based Rheonix is expanding its services and local footprint, with a new facility here and a new push of its COVID-19 PCR testing, which it was one of the first companies to offer locally in spring 2020.
Since the early stages of the pandemic, the company has been providing widely scalable, streamlined COVID-19 testing in the mid-Atlantic and Northeastern regions of the U.S. Now, Rheonix has recently announced the opening of a new lab facility in Ithaca.
The laboratory is a Clinical Laboratory Improvement Amendments (CLIA-certified) facility with permission from New York State to administer a COVID-19 polymerase chain reaction (PCR) testing program. The company is touting this as a way to deliver low-cost PCR testing to those who want it.
Rheonix Laboratories first received an emergency use authorization (EUA) in April 2020 from the U.S. Food and Drug Administration (FDA) for the Rheonix COVID-19 MDx Assay to conduct PCR testing, which produces reliable results since it “is highly sensitive and detects all COVID-19 variants of concern, including the Omicron subvariants … [while also] reducing turnaround time from two weeks to same day,” the press release states. Since receiving the EUA, Rheonix’s COVID-19 diagnostics mechanism has helped U.S. laboratories conduct over 1 million COVID-19 tests.
Though the Rheonix COVID-19 testing system has proven to be a success, its development encountered some uncertainty at first.
“When COVID was first becoming an item back towards the end of 2019, we debated back and forth [about] whether we should develop a test for COVID or not,” said Greg Galvin, President, CEO and Chairman of the Board of Directors of Rheonix. “We were a little bit hesitant given that some of the previous respiratory viruses, like SARS and MERS, had come and gone in a pretty short order, but [we ultimately] decided that we would go ahead and develop the assay for the SARS-CoV-2 virus.”
After submitting the assay to the FDA and receiving the EUA, Rheonix tackled the challenge of scaling the testing method.
“[It] was actually an incredibly wild ride of trying to ramp capacity to produce instruments and produce the assays … because we and pretty much everyone in the diagnostics industry were not prepared to start producing the volumes of testing that [were] ultimately needed for the pandemic,” Galvin explained. “So, for about a year [it] was [a] 24/7 operation, all hands on deck — make as much stuff as we could and get it out as fast as we could.”
After a successful rollout of the COVID-19 assay, Rheonix saw a sudden decrease in testing due to an absence of industry supply chain regulations — allowing tests from other manufacturers to be widely accessible — as well as an emergence of antigen rapid tests, which began to overtake PCR tests in popularity.
“So, our COVID business now is relatively small,” Galvin commented. “Not zero, but compared to the peak of the pandemic, it’s quite small.”
Galvin noted that the PCR test remains the gold standard for COVID-19 testing due to its reliability. “There’s some value to widespread, cheap at-home antigen testing, just because it gets more testing capability out there,” he acknowledged. “But, it does have a pretty high unreliability factor around it.”
In the meantime, Rheonix will continue to monitor any new variants and ensure that its test is capable of detecting them.
“In the public domain, you hear about one or two variants, but in the scientific domain, there are tens of thousands of variants,” said Galvin. “So, we have people continuously running computer programs that will get the published variant genetic sequences and compare them against what our test is looking at to make sure that our test will still pick them up.”
In addition to reliability, Rheonix ensures accessibility to its COVID-19 PCR tests. According to the press release, the new laboratory “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 primary focus, Galvin said, is “to provide a convenient and economical COVID-19 PCR testing option for organizations and community members.”
Those interested in registering for a COVID-19 PCR test at Rheonix can visit the Rheonix Laboratories website, access the Patient Portal, create a patient profile, schedule an appointment and select the desired sample type (anterior nasal swab or saliva). Results should be available to view on the portal within 24 hours after the sample arrives at the laboratory.