LARGO — Entrepreneur Fazal Fazlin finds himself on the cutting edge of medical research.
That’s not at all what the Tampa Bay millionaire and a friend had in mind when they dreamed up Kaligia Biosciences over lunch at Cafe Ponte years ago. Their goal was to find a less invasive way for people with diabetes to test their glucose levels.
They did that. Then came the rise of COVID-19, the disease caused by the novel coronavirus, and Fazlin wondered whether their technology could do more.
Now, Largo-based Kaligia Biosciences is conducting clinical trials for a saliva test that, according to the company, can detect COVID-19 in just three minutes. The possibilities, should the test meet rigorous requirements and win approval, are far-reaching.
With such a quick turnaround, Fazlin said, the screening would help people and the economy return to a new normal. Worried about flying? Visiting a theme park? Holding a board meeting? A quick, accurate test conducted onsite would comfort participants, Fazlin said.
“Once we have that, then life becomes a little bit easier, a little less stressful,” he said. “It’s such a great feeling that, if we get this process all working, we would be able to help people not be afraid of going out. People wouldn’t be afraid to interact.”
First, Kaligia needs to make sure the machine it uses to screen the samples is accurate. The company started clinical trials this week, gathering samples from local healthcare providers to help the machine learn to detect COVID-19 in saliva.
The most common way now to analyze samples for COVID-19 is to trigger a polymerise chain reaction. This is how screening is done on samples collected with those six-inch nasal swabs at drive-thru sites throughout the country. DNA and RNA help determine whether the virus is present.
Kaligia’s device, the size of a shoebox and called the Rapid Biofluid Analyzer 2, relies on a different approach. It points a laser at the saliva to reveal the underlying chemical components and then draws on machine learning to identify positive and negative results.
This sets the test apart from other screenings on the market, said Dr. Stephen Liggett, vice dean of research at the University of South Florida Morsani College of Medicine.
“We are enthusiastic about the approach,” Liggett said. “To be able to explore different ways of detecting the virus is really important in trying to formulate an overall public health plan.”
It will be some time before people in the Tampa Bay area see the testing device in an airport or office building.
In order to get approval from the U.S. Food and Drug Administration, Kaligia must prove that its method is accurate and reliable. That’s where the clinical trials come in.
Using partnerships with USF, Tampa General Hospital and AdventHealth, the company is collecting 150 to 200 samples from both positive and negative patients to teach the machine how to accurately identify the virus.
The timeline depends on how fast they can get the samples.
“Fortunately for Tampa Bay, but slightly unfortunately for us, there are not many subjects available at hospitals in Tampa,” Fazlin said.
The company is prepared to collect samples from South Florida and New Orleans, hotspots for the virus.
Fazlin hopes to have the device ready for review by hospitals and the FDA in a few weeks.
The FDA has expedited its approval process during the pandemic, but Liggett said officials are still looking for a high level of accuracy.
“We can already see, as you’ve seen in the news, that there are kits which really are not necessarily always right,” Liggett said. “They’re very wary of that, and they want to do it right. They’re fast, but they’re still looking for that level of accuracy.”
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