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Test created by Sarasota doctor could help triage COVID-19 patients, alleviate testing burden

Researchers at the University of Southampton published a report about a device that could help triage patients and reduce the spread of COVID-19.

SARASOTA, Fla. — You've heard it over and over: testing is key to finding coronavirus outbreaks under control. However, when many are waiting a week or more for results, it's clear something in the system is broken.

A simple device created by a Tampa Bay area doctor could be the answer, but there are still hurdles to clear.  

RELATED: Another 180 Floridians have died from COVID-19, state reports

"It's certainly frustrating, because I really want to make a difference, and we have something that's proven to do just that,” said Dr. Rob Sambursky, president and CEO of Lumos Diagnostics.

That "something" is a test called FebriDx, cited in the Journal of Infection for its ability to distinguish between bacterial and viral infections in ten minutes or less with one simple prick of the finger.

"...If they're viral, then they could have a higher risk or probability of having COVID-19. Those patients could then be prioritized to have the confirmatory testing, and maybe get those results a lot earlier,” Sambursky said.

That's huge -- a public health expert at the University of South Florida said this kind of test could reduce the use of unnecessary antibiotics. Another doctor said it could be key to cutting down wait times for COVID-19 tests. 

"It might help triage or able us to make determination to who does need COVID-19 testing and who doesn't," said Dr. Eliot Godofsky of Bach and Godofsky Infectious Diseases in Manatee County. He participated in a clinical trial for the test.

"This would make giant strides in getting us out from under the pressure that this pandemic is putting on us," he said. 

FebriDx is used in UK hospitals, and researchers at the University of Southampton just published a report about how the device could reduce the spread of COVID-19 in hospitals.

But the test Sambursky, of Lumos Diagnostics in Sarasota, worked to develop has yet to get FDA approval, despite years of development and clinical trials.

"We moved forward with a US pivotal trial with the FDA. It was unfortunately interrupted by the pandemic,” he said. "One of the reasons we partnered with Homeland Security was because of the concern of a potential pandemic, and could we have something that was broadly able to look at viral or bacterial infections."

Unfortunately, that's the problem. FDA approval requires something that looks at a specific virus. This test can tell you if you have a virus, but it won't detect COVID-19.

"If you don't have a test that's very specific, either an antibody, an antigen or the swab for RNA for that virus, it doesn't fall under the EUA,” Sambursky said.

EUA stands for Emergency Use Authorization, which allows the FDA to approve drugs or products faster during a public health emergency.

"We're sitting on something that could have a profound impact on helping people," Sambursky said. "I've had many sleepless nights waiting for, you know, an opportunity to make a difference at home."

Sambursky says his company's working on a regulatory strategy to get the test approved in the US and plans to use data from the UK and published studies to support that effort.

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