Ithaca N.Y.’s Cayuga Health System Laboratory reduced turnaround times for COVID testing from two weeks to same-day and quickly scaled to meet testing surges and demands, thanks to its partnership with Rheonix.
By Bruce Estes
In the fall of 2021, the U.S. was breathing a collective sigh of relief as the Delta variant of COVID-19 subsided and the nation looked forward to reuniting with family and friends for the upcoming holiday season. Fewer people were sick, COVID-19 positivity rates were down, and the pressure on testing labs had begun to abate. Unfortunately, the calm was short-lived. The hope of returning to our pre-pandemic lives was dashed by the emergence of a new SARS-CoV-2 variant. On Friday, November 26, the day after Thanksgiving, the World Health Organization designated Omicron as a highly contagious variant of concern. Within days, U.S. labs were gearing up for the Omicron variant’s inevitable appearance.
In Ithaca, New York, the Cayuga Health System Laboratory began preparing for another testing surge that would require them to deliver rapid and reliable COVID-19 test results to customers throughout New York State. They were assisted in this effort by Rheonix, Inc., a molecular diagnostics company they partnered with earlier in the pandemic. By the end of Thanksgiving weekend, the Rheonix R&D team had evaluated all available sequences of the Omicron variant and determined that their assay’s performance would not be impacted. Before the first U.S. case of Omicron was confirmed on December 1, the Cayuga Health System lab was prepared to respond with its fully automated Rheonix Encompass MDx workstations and readily available Rheonix COVID-19 MDx assay reagents.
Cayuga Health System’s Early COVID-19 Response
Prior to the COVID-19 pandemic, the Cayuga Health lab was completing more than 1 million diagnostic tests annually for the eight counties Cayuga Health serves in central New York and its Finger Lakes region. A major renovation a few years earlier added new floor space that was now occupied with advanced diagnostic equipment, tracking technology, and more staff to handle large-scale testing.
When the SARS-CoV-2 virus emerged in early 2020, Cayuga Health and local county health departments set up mass testing programs. The programs poured many thousands of tests per week into the diagnostic pipeline; with demand skyrocketing for COVID-19 testing, pressure was building for the Cayuga Health System Laboratory to deliver results quickly. Like hundreds of other regional hospital labs, Cayuga had difficulty procuring the reagents needed to perform the tests. In the face of steep national demand, regional labs lacked the buying clout of larger labs to obtain the critical materials needed to operate their diagnostic equipment. Toni Burger, the Cayuga Health Laboratory’s administrative director early in the pandemic, vividly framed the problem.
“We had about 12 pieces of equipment in the lab that could be used for COVID diagnostics, but we couldn’t get the reagents. It was like having cars in your garage and no gasoline to run them,” Burger recalls.
With waves of samples arriving daily, many labs, including Cayuga, began sending their samples to large reference labs and major hospitals, exacerbating the testing bottlenecks. The pace of results reporting dramatically slowed, affecting the U.S. pandemic response.
“That meant our turnaround times were two, sometimes three weeks or even longer,” says pathologist Elizabeth Plocharczyk, MD, the current director of the Cayuga Health System Laboratory.
As Plocharczyk saw the impact of delayed test results on patients, physicians, and health departments across the state, she and the Cayuga Health System laboratory staff of about 100 managers, technicians, and technologists began looking for a solution. They found it 10 miles away from the hospital laboratory at Rheonix, Inc., a developer of fully automated molecular tests for clinical, applied, and research applications.
In February 2020, Rheonix’s workstations and assays were in use in U.S. and international food and beverage testing and research laboratories, and Rheonix was awaiting U.S. Food and Drug Administration (FDA) 510(k) approval for its sexually transmitted infection assay. As COVID-19 began to spread, Rheonix’s leaders realized their fully automated Encompass MDx workstation could make a valuable contribution to the U.S. testing solution since it was affordable, easy to use, required minimal hands-on time, and could be quickly deployed to smaller regional labs.
Tests could be processed in-house with existing personnel and resources, providing critical same-day results. The company committed its efforts to the pandemic response. The scientific team designed and validated a molecular COVID-19 assay, while the operations team expanded manufacturing capacity and secured additional suppliers. On April 29, 2020, Rheonix received FDA emergency use authorization1 (EUA) for its fully automated COVID-19 MDx Assay for use with respiratory specimens and began deploying the system to regional laboratories.
Within days of Rheonix’s receipt of the EUA, Cayuga Health System installed two Rheonix Encompass MDx workstations, started in-house testing, and began delivering same- or next-day results.
“Providing patients and their physicians with a quick diagnosis allows for rapid patient management decisions,” says Marty Stallone, MD, Cayuga Health System’s president and CEO. “Knowing if a patient has the disease or not means appropriate care decisions can be made. In situations such as childbirth or emergency care, quick test results can rule out the need for isolating a patient with a negative test finding or signal the urgent need for protecting others when a patient has a positive result.”
Another four workstations soon followed. The low-cost, scalable system enabled the Cayuga Health lab to reach the broader community, while conserving critical lab tech time.
“The Rheonix technology allowed us to expand Cayuga Health’s COVID testing program to include college campuses, public school systems, government offices across central New York and into the metropolitan area,” says Plocharczyk, Cayuga Health System’s laboratory director. “It’s been instrumentally changing for us. We want to be able to take care of our community and keep our population healthy and our employers and schools open. It’s really important for us to contribute to the community in that way. By building up our COVID testing capability, we’ve been able to do that.”
By July 2020, the Cayuga Health lab completed over 50,000 COVID-19 tests, a number that rose to 400,000 by late October. The addition of workstations enabled Cayuga Health to maintain response times while keeping up with the 2020 holiday testing surges. With the emergence of the Delta variant in the summer of 2021, testing unexpectedly surged again. Fortunately, the required test kits were available. Throughout the pandemic, Rheonix kept its supply chain front and center. To ensure instrument and reagent availability, the company increased headcount and invested in automated production lines, increasing production capacity 30-fold in the first year of the pandemic.
As of February 2022, the Cayuga Health Lab has logged nearly 2.5 million COVID-19 tests. Its diagnostic capabilities play a key role in patient care at Cayuga Health’s two New York hospitals—Cayuga Medical Center in Ithaca and Schuyler Hospital in nearby Montour Falls. Among the lab’s many corporate clients is Corning, Inc., which sends test samples from its locations across the U.S.
For Rheonix, the partnership with Cayuga Health System produced two key benefits: first, it provided a front-row view into the daily challenges and changing requirements of COVID-19 testing and, second, it created a template for effectively supporting other U.S. regional labs. Ongoing, real-time information from its partnerships with Cayuga Health and other labs has enabled Rheonix to respond nimbly to the rapidly changing pandemic landscape. For example, collaborations with Cayuga Health and other regional laboratories were critical in attaining expanded EUA for use of saliva as a sample type, making sampling safer and testing less expensive. Customer collaborations have also accelerated development of Rheonix’s assay menu, including a multiplex assay for COVID-19, influenza, and RSV, as well as a comprehensive gastrointestinal panel.
“Our team has greatly enjoyed the productive and mutually beneficial relationship with Dr. Plocharczyk and the rest of the staff at Cayuga Health as they helped us validate our EUA and provide continuing and invaluable insights for our broader portfolio under development” says Richard Montagna, PhD, FACB, senior vice president for scientific and clinical affairs at Rheonix.
Hope abounds that the COVID-19 case map will continue to fade from dark to light, and normalcy will finally return to the U.S. and the world. Whatever COVID-19 brings next, a collective ability to respond will depend on laboratory-supplier partnerships and flexible solutions that meet a range of laboratories’ needs.
Featured Image: Before the first U.S. case of the Omicron variant of COVID-19 was confirmed on December 1, 2021, the Cayuga Health lab was prepared to respond to surge testing with the automated Rheonix COVID-19 testing system. Photo: Cayuga Health System
ABOUT THE AUTHOR
Bruce Estes is based in Ithaca, N.Y., and writes regularly on health, science, and history topics.
1. About Emergency Use Authorization: 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 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.