Cayuga Medical Center to be First Hospital in NY State to Use This New Technology
April 30, 2020 Ithaca, New York –– Cayuga Health (CH) and Rheonix Inc. announced today that they are now able to provide same day turnaround for COVID-19 test results. Rheonix received Emergency Use Authorization (EUA) from the FDA for the Rheonix COVID-19TM MDx Assay on April 29, 2020. The rapid sample-to-answer test enables the fully automated detection of SARS-CoV-2, the virus that causes COVID-19, directly from respiratory samples. The test is designed to operate on the Rheonix Encompass MDx® workstation, and will facilitate same-day results at distributed testing locations.
Rheonix Inc., a company based in Cornell University’s Business and Technology Park, and founded by Ithacan Greg Galvin, Ph.D., is built around the goal of addressing unmet needs for rapid, sensitive and specific molecular testing across a variety of markets. This idea led to the invention of the Rheonix CARD® cartridge and Encompass family of workstations, fully automated, highly versatile and easy-to-use testing systems.
“We are thrilled to team with Rheonix, located right here in Ithaca. Their technology and expertise has enabled us to be able to provide same day results for COVID-19 testing – one of the quickest turnaround times in our region,” states Martin Stallone, President & CEO of Cayuga Health. “We were successful with opening one of the first COVID-19 drive through sampling centers in our state and will continue to do what it takes to fight this epidemic and meet the healthcare needs of our community, right here.”
“I am incredibly happy to be able to support Cayuga Health – Rheonix’s hometown health system – with their fight against this COVID-19 pandemic by giving them the ability to provide same day test results to their patients,” said Greg Galvin, President, CEO & Chairman of the Board of Directors, Rheonix Inc. “Because our fully automated system is so easy to deploy and operate, it’s a perfect solution for rapid testing in hospitals like Cayuga Health,” adds Galvin. “The faster people can get diagnosed, the faster they can get treated, and the faster we can turn the corner on this pandemic.”
“We typically see between 150-250 patients a day at the sampling center and before implementing the Rheonix system it could take a few days to get the test results back,” stated Dr. Elizabeth Plocharczyk, Specialist in Anatomical and Clinical Pathology at Cayuga Health. “Until now, we had been sending the samples to a large commercial lab for testing. With this new test method we can process around 200 samples per day, right here in the hospital. ”
The Cayuga Health/Tompkins County Sampling Center, which opened March 24, is available for drive through testing from 10am-3pm, Monday-Friday. A new website with on-line registration is available at www.cayugahealth.org for patients to review the screening criteria and pre-register before their arrival, allowing greater efficiencies with patient volume and decreased wait times.
In addition, a call center has been set up for patients who may not have access to Internet, need assistance registering, or have questions. The call center number is 607-319-5708. Individuals are strongly encouraged to pre-register prior to coming to the site.
The Sampling Center is located in portable structures at The Shops at Ithaca Mall parking lot and is staffed by experienced and knowledgeable Cayuga Health employees. Screening includes obtaining respiratory samples, which are then sent to Cayuga Health Laboratory for results.
Patients entering the screening location by car can tune into FM 96.3 to receive instructions about driving through the Sampling Center. In addition, signs will convey important information to assist with traffic control. If you do not have transportation, please do not take public transportation to the sampling center. Cayuga Health and Tompkins County officials are working closely to determine if mobile sampling is available or other transportation options. The public will be updated about these options. Pre-registration is also available online at www.cayugahealth.org or by calling 607-319-5708.
As directed by Governor Cuomo, COVID-19 testing is free for all New Yorkers, regardless of health insurance.
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 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.
About Cayuga Health
Cayuga Health (CH) has two hospitals, Cayuga Medical Center and Schuyler Hospital, as well as a multi-specialty group, Cayuga Medical Associates. Combined employment, including affiliated organizations, is over 2,200 employees. CHS is clinically linked to Mayo Medical Laboratories, Rochester Regional Health for cardiac services, Roswell Park for cancer services, and the University of Rochester for neurosciences.
About Rheonix, Inc.
Rheonix has developed the suite of Encompass workstations, fully automated systems that provide highly multiplexed sample-to-answer molecular testing for use in clinical, research and applied testing laboratories. With minimal hands-on time, the Encompass systems offer true walkaway simplicity. Rheonix’s growing portfolio offers multiplexed testing solutions including the Beer SpoilerAlert™ assay, the most comprehensive beer spoilage panel available; the Listeria PatternAlert™ assay, a rapid method for Listeria strain typing; and the NGS OnePrep™ solution, a fully integrated and automated DNA extraction and library prep solution. The Rheonix STI TriPlex™ Assay and Rheonix Encompass MDx® workstation are currently undergoing FDA 510(k) review. Rheonix has received Emergency Use Authorization (EUA) from the FDA for Rheonix COVID-19TM MDx Assay. The rapid sample-to-answer test enables the fully automated detection of SARS-CoV-2, the virus that causes COVID-19, directly from respiratory samples. For more information, visit www.rheonix.com.