Sight Diagnostics, an Israel-founded company that develops lab-grade blood testing systems, announced on Wednesday that it received Food and Drug Administration 510(k) clearance for its OLO analyzer, a device that performs blood tests and provides lab-grade results in minutes. Crucially, this includes CBC (Complete Blood Count) tests which are the most basic and informative tests medical professionals can conduct.
OLO leverages AI with a revolutionary method to “digitize” blood, allowing patients to receive blood test results within minutes at the point-of-care, and with just a finger-prick. The system takes detailed images of the blood with just two drops, Sight says, and then analyzes them with computer vision algorithms. The system was first deployed in African countries and India in 2014 to detect malaria.
Sight says the analyzer is compact, easy to use, and can reduce costs in low-volume settings. OLO is designed to empower even non-professional users, with a system that comes pre-calibrated and features single-use test cartridges. It is also conveniently sized and priced with smaller clinics in mind, Sight says.
The FDA clearance follows clinical trials at Boston Children’s Hospital, Columbia University Medical Center and Tricore Labs, and enables OLO’s use in laboratories run by hospitals, diagnostic providers, and outpatient clinics, the company said in a statement.
“To treat children in our urgent care centers, a CBC is essential. OLO represents a major innovation in our laboratories’ CBC analysis: introducing finger-prick and venous sampling, five-part differential and flagging. It’s a truly welcome development,” said Dr. Steven Melnick, Chief of Pathology at Miami’s Nicklaus Children Hospital, which is already evaluating the technology. “At current volumes, we believe OLO will substantially reduce our costs.”
“The years our R&D team spent solving complex engineering and design challenges have positioned us well to expand our offering in the future,” said Sarah Levy, Sight’s CTO. “Our end-goal is to offer diagnostics for any disease with visible signatures in the bloodstream. We are confident Sight can continue to improve patient outcomes through new, faster, less costly, and more convenient testing.”
The OLO analyzer is available commercially in Europe and is being evaluated by institutions such as Oxford University Hospital Trust, both its Surgical Emergency Unit and Oncology Clinic.
Sight says it also initiated a pilot program with major UK pharmacy chain Superdrug to bring blood testing to their health clinics.
The company says it has six patents with more pending and intends to pursue furth FDA approval to certify OLO for use in smaller medical practices and pharmacies in the United States.
Sight Diagnostics was founded in 2011 by a team that includes Harvard-trained biotechnologists, experts in AI, and instrumentation engineers, many of whom hail from the world-renowned IDF technology units.