The reopening of the world economy is largely reliant on easy and accessible COVID-19 screening. Kaligia Biosciences, a medical device company, is working with major Florida medical institutions to develop a portable, saliva-based device that can produce results in less than three minutes.
Kaligia Biosciences is starting clinical trials of the Rapid Biofluid Analyzer 2 (RBA-2) device this week, using saliva samples of COVID-19 from Bay-area hospitals and beyond.
The method uses a proven Kaligia Biosciences device that analyses multiple blood components. Kaligia Biosciences is collaborating with AdventHealth, the University of South Florida College of Pharmacy (USF) the USF College of Medicine and Tampa General Hospital (TGH) to adapt the device for COVID-19 screening.
“Currently, COVID-19 tests require uncomfortable nasal swabs or blood samples, and can take days, if not weeks to obtain results. We want to make screening more accessible, faster and non-invasive,” said Kaligia Biosciences Chief Executive Officer Fazal Fazlin. “The device we are developing can scan a simple saliva sample and produce results almost instantly. The machine is portable (smaller than a shoe box) so it will be accessible to hospitals, pharmacies, doctors’ offices and clinics.”
The difference between RBA-2 and other devices is the underlying technology. The RBA-2 uses Laser-Raman spectroscopy, directing a laser at a sample to reveal the underlying chemical components, and then draws on machine learning to identify positive and negative results. This avoids the time-consuming and highly delicate process of most current tests that utilize “wet” chemistry to test fluid samples.
Kaligia Biosciences is collecting positive and negative samples from patients in Tampa, Miami and New Orleans, then uses their proprietary machine learning algorithms to process the data and predict accurate results.
“We are enthused about this particular project because we recognized early on that testing for the virus and antibodies will be an important part of healthcare and public health,” said Stephen Liggett, M.D., Vice Dean for Research at the USF Morsani College of Medicine, who is leading a series of COVID-19 clinical trials with Rachel Karlnoski, Ph.D., Director of Clinical Research at USF. “There are many ways to attack this problem, but most current methods concentrate on one or two very traditional approaches that can be prone to false positives and false negatives. You need technology that offers the promise of being able to rapidly detect with a high level of accuracy.”
Kaligia Biosciences anticipates having the RBA-2 device ready for review by hospitals and the Food and Drug Administration in a few weeks. “Since we already have the blood analyzer in development, we believe we can produce this next generation for COVID-19 saliva screening very quickly,” Fazlin said.
“The need for rapid COVID-19 screening is clear,” said Dr. Kevin Sneed, Dean of the USF Taneja College of Pharmacy. “We must bring to bear the best possible technology and most innovative approaches to this challenge.”