Data collection underway with AdventHealth, University of South Florida College of Medicine and College of Pharmacy and Tampa General Hospital
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 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 Co-Founder and CEO 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.
Step 1: Subjects provide a sample of saliva for screening.
Step 2: The sample is inserted in a disposable viewing station attached to the RBA-2.
Step 3: The spectrum of the saliva sample is recorded and used to produce a positive or a negative result for COVID-19.
Step 4: Researchers dispose of the subject’s tube and viewing station, ensuring safety, and eliminating risk of cross-contamination.
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.”
About Kaligia Biosciences
Florida-based Kaligia Biosciences has extensive experience producing devices to test blood components. Co-Founder and CEO Fazal Fazlin has built bioscience companies involved in testing, medical devices, and artificial intelligence. Kaligia Biosciences was started in 2015 by entrepreneurs, engineers, and visionaries to contribute in the next big healthcare evolution. The company is tapping into the power of emerging technologies and creative problem solving to innovate a new breed of biosensors. These devices, which produce quantifiable results with unprecedented speed and accuracy, align with Kaligia Bioscience’s mission to redefine medical diagnosis and transform healthcare delivery from reactive to proactive. www.kaligiabiosciences.com