– Sight Diagnostics, the company working to provide patients with lab-grade blood testing results in minutes, has received US FDA 510(k) clearance for its finger-prick blood test, OLO analyzer to be used in laboratories run by diagnostic providers and hospitals.
– Sight Diagnostics’ patented OLO analyzer digitizes blood into images to perform the most common blood test in minutes, from just two drops of blood
– The FDA clearance follows clinical trials at Boston Children’s Hospital, Columbia University Medical Centre and Tricore Labs.
– As Sight moves into the US market, the largest In-Vitro Diagnostics (IVD) market in the world, OLO is already commercially available in Europe and other international geographies for use at the point-of-care via fingerprick testing.
Israeli-based Sight Diagnostics is doing what Theranos never could: delivering accurate blood test results with a finger-prick sample in minutes. And they just received the FDA nod to do so in the US. Sight Diagnostics, the company working to provide patients with lab-grade blood testing results in minutes, has received US FDA 510(k) clearance for its OLO analyzer to be used in laboratories run by diagnostic providers and hospitals.
The Quicker We Diagnose, The Faster We Can Treat
Each day millions of physicians postpone prescribing medical treatment because they lack timely access to accurate blood test results. The complexity and cost of small volume testing see most blood samples returned following lengthy processing times, which can delay treatment for patients.
Founded in 2011 by Yossi Pollak and Daniel Levner, Sight Diagnostic’s mission is to change this reality by providing affordable and accurate diagnostics in a compact platform designed for use in qualified labs in low volume settings. The company first deployed its technology to detect malaria and has since delivered nearly one million tests in 24 countries. Then it applied the same clinically-tested technology to build an analyzer that can perform a Complete Blood Count (CBC)—the most commonly ordered blood test—in minutes with just two drops of blood.
OLO. Complete Blood Count from a Finger-Prick and Two Drops of Blood
The OLO analyzer, which performs a ubiquitous and essential blood test, the “Complete Blood Count” (or CBC). OLO provides lab-grade CBC results in minutes. The analyzer is compact, easy to use, and can reduce costs in low-volume settings. “The CBC is frequently used as a data point in determining whether an ailment is viral or bacterial,” said Dr. Carlo Brugnara, Director of the Hematology Lab at Boston’s Children’s Hospital and Professor of Pathology at Harvard Medical School. “In rarer cases––involving acute leukemia, for instance––a CBC can make the difference between life and death.”
The FDA clearance follows clinical trials performed at Boston Children’s Hospital, Columbia University Medical Centre and Tricore Labs, and enables OLO’s use in laboratories run by hospitals, diagnostic providers, and outpatient clinics.
How It Works
The complete blood count––which enumerates and characterizes the number of red blood cells, white blood cells, and platelets in a patient’s blood sample––is one of the most basic, informative tests a doctor can conduct
– Using a patented method of “digitizing blood samples,” the analyzer automates the identification and counting of different blood cell types and anomalies and runs it through Sight’s proprietary machine vision algorithms
– The analyzer returns accurate blood test results within minutes
– OLO is compact, easy to use, and can reduce costs in low-volume settings
Impact of U.S. FDA Clearance
OLO’s FDA approval confirms its lab-grade performance while operating from just two drops of blood, using either a finger-prick or venous sample. Combined with OLO’s size, this renders the analyzer attractive in many clinical settings––where the case for high-volume laboratory equipment doesn’t add up.
“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.” says 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.”
As Sight moves into the U.S. market, the OLO analyzer is already commercially available in Europe and other international markets. The technology is being welcomed by world-renowned institutions, such as Oxford University Hospital Trust, which is currently evaluating OLO in both its Surgical Emergency Unit and Oncology Clinic. Recently, Sight also initiated a pharmacy pilot program with major U.K. chain Superdrug to bring blood testing to their health clinics. Meanwhile, Sight is establishing partnerships in Africa, Asia, and South America and has rapidly growing offices in Israel, the UK, and the USA.
Six U.S. patents have been granted to Sight relating to these technological innovations, with more pending. In the future, Sight intends to pursue a CLIA waiver from the FDA to certify OLO for use in smaller practices and pharmacies in the United States.
“The years our R&D team spent solving complex engineering and design challenges have positioned us well to expand our offering in the future,” says 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.”