An Ithaca molecular testing company believes they have developed a new, quicker way to test patient samples for the coronavirus, the pandemic that’s already killed 12,000 people across the country and infected thousands more.
The company, Rheonix, is awaiting approval of their device by the Food and Drug Administration, which would potentially come in the next few weeks once Rheonix proves its invention’s worth. According to Brooke Schwartz, the company’s VP of marketing and strategy, the new testing apparatus would mean cutting testing time significantly, from days to just hours, and allowing patients and doctors alike to know much quicker if someone is positive for coronavirus and to initiate treatment and isolation.
Rheonix is one of countless companies around the country that are trying to fill the gaps in testing created by the ravenous spread of the COVID-19 virus. There have been plenty of critiques levied at the currently available testing process, which includes a nasal or cheek swab sample being sent away to a separate facility with testing operated by the Center for Disease Control. The results of those tests are sent back to the local health departments or healthcare providers and patients are then informed of their results and instructed of next steps. The process has fluctuated, but seems to take somewhere between five and nine days, on average, from swab to results.
“We are getting ready to submit our data to the FDA for an emergency use authorization, we hope to do that in the next couple of weeks,” Schwartz said. “We hope to get the authorization very quickly and then to get products shipped within the next several weeks.”
The test would not be a do-it-yourself test, as some have hoped would be developed soon and as has been discussed as a possible solution to testing availability issues. But because it would require very little manual intervention, the test would speed up the process exponentially.
“It is fully automated and doesn’t require sophisticated training but it still needs to be done by a lab technician, it’s not something you would do at home,” Schwartz said. “If you’re referring to collecting the sample at home, that’s an FDA call. All of these methods require a sample that’s collected from a patient, but right now all FDA is approving is samples that are collected by a trained personnel at a collection site. To my knowledge, they haven’t approved any methods at home.”
This type of work would not be out of Rheonix’s typical wheelhouse, Schwartz said, though obviously it would be the first time they were trying to detect coronavirus specifically. Testing times and availability shortage has emerged as one of the primary themes of the ongoing pandemic, along with a continued need for more medical supplies like ventilators and personal protective equipment like N-95 masks. Schwartz acknowledged the widespread interest in the molecular testing field to find a testing solution, but noted that there are a variety of lanes different companies can pursue to address the problem in different ways.
“It’s a race for everyone to get testing methods on the market, it isn’t a one-size fits all testing market,” Schwartz said. “Different types of facilities benefit from different types of solutions. [...] Our system is highly automated. It’s low- to medium-input, so it’s perfect for local and regional, state, city and county levels."