In New York state, tests for COVID-19 can take a week to return results, a process that inhibits efforts to flatten the curve and slow the spread of the coronavirus. One local company, based in Cornell University’s Business and Technology Park, is working to change that, cutting the wait time for results from days to just a few hours.
Rheonix Inc., a company founded by Ithacan Greg Galvin, Ph.D., is built around the goal of addressing unmet needs that “prevent the adoption of high-quality, sensitive and specific molecular testing across a variety of markets,” according to the company’s website.
This idea led to the invention of the Rheonix CARD cartridge and Encompass workstation, a highly functional and easy-to-use testing device.
“With both the Rheonix CARD cartridge and Encompass workstation family of products, Rheonix is well positioned to penetrate key molecular testing markets, from diagnostics labs to applied markets testing for food and beverage applications and next-generation sequencing sample preparation,” according to the company’s website.
Encompass workstations can take almost any raw sample input and automatically process up to 24 samples at one time, producing results in four to five hours, said Vice President of Strategy and Marketing Brooke Schwartz.
“The automated platform enables somebody who has very little technical training to actually run the instrument because you go straight from a clinical sample or a food sample under the instrument, and you get a result in four hours without having to do any type of sophistication manipulation of the sample,” Schwartz said.
As soon as Rheonix heard of the growing coronavirus problem, leaders knew their equipment could be used to test for the coronavirus with relatively little change to the technology.
“We knew other tests were being developed, but it also was immediately clear that there was going to be a need for a lot of different types of testing and a lot of different solutions to this problem,” Schwartz said. “The shortage of testing is one of the single biggest issues right now that everybody’s contending with.”
While there are a variety of approved tests and testing methods for COVID-19, many require a high degree of technical expertise. Some platforms are very high throughput, meaning they can process hundreds of tests per day. Schwartz described how Rheonix’s platform is different.
“Our test is low to medium throughput, but it is completely, fully automated, so there is no up-front sample prep that needs to be done by a technician, so nobody has to handle the sample, nobody has to do any kind of sophisticated manipulation to extract the DNA,” she said. “It’s small, it’s inexpensive, and the per-test cost is relatively inexpensive compared to some of the others, so it is very well suited to county or regional hospitals and testing labs.”
Schwartz said that Rheonix’s technology, when used in county or regional hospitals and testing labs, can help produce results much faster than what is currently available.
Galvin is on the board of Tompkins County Area Development, and President Heather McDaniel said she’s glad to see a local company succeeding in this way.
“I am really hopeful that the work that they’re doing will lead to faster turnaround and testing for COVID-19,” McDaniel said. “We’re fortunate that we have a lot of companies here and in upstate New York that do really high-tech research and are on the cutting edge of really amazing technologies, so I just feel like we’re lucky that we have companies like this that are looking at real-world problems and how to solve them.”
Schwartz emphasized that Rheonix is not seeking to compete with current testing platforms and recognizes that the more testing methods being used, the better.
“It’s not the time to be better than everybody else; it’s the time to contribute what you can contribute where it’s most applicable, so our method is most applicable in a low-to-medium-throughput hospital,” she said. “We are not a high-volume test method, so for big, high-volume, high-throughput labs, our system isn’t a fit, but for a small county or regional hospital lab, we are a fit. So, it’s more of an issue of where do you fit? And the good news is there’s room for all of us to be testing because there aren’t enough tests to go around.”
To provide this testing platform to labs, Rheonix needs FDA approval under Emergency Use Authorization. Schwartz said Rheonix has been working with FDA guidance on full EUA submission, which the company hopes to complete by mid-April. She said the FDA has done a lot to speed up the process.
“The FDA has been moving at an unprecedented rate to simplify the review process, simplify the amount of validation that needs to be done in order to be confident that the test works but not over burden the manufacturers so we can get tests into the market as soon as possible,” she said.
Once Rheonix completes full EUA submission, authorization is expected within one to three weeks.
“Everybody’s working as fast as they can,” Schwartz said. “The challenge is always get it done as quickly as you possibly can. We’re taking every resource that we have in the company and putting it on this.”
Rheonix faces all the challenges of workplace safety that many businesses are facing right now, Schwartz said, which makes bringing this test to market more difficult.
“It’s a challenging time to come to work, and all of our people are showing up,” she said. “They’re working. They’re staying safe. We’re facing, I’d say, the same challenges that every other organization is facing that needs to keep running in the face of the public health threat.”
Through it all, though, Schwartz said she’s proud of the work Rheonix is doing and knows that everyone is working hard to distribute a test that could make a big difference in the fight against COVID-19.
“It’s unbelievably motivating and energizing to be doing a job that contributes to fighting the pandemic,” Schwartz said. “I’ve never seen the company pulling together in this way, so motivated, so excited, so energized and so committed to delivering a test against all odds as quickly as possible. I would say they’re doing fantastically, and they’re staying safe, and they’re showing up. This is when people show up, at times like this.”
Once this testing technology is widely available, Schwartz is optimistic about the effect it’ll have on medical sectors across Tompkins County and the rest of the state.
“We see it enabling very rapid turnaround for testing in local communities, and right now, people need to get diagnosed so they can get treated, and the faster they can get diagnosed, the faster they can get treated and the faster we can understand the extent of this pandemic,” she said.
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