FDA clears finger-prick blood test for US market

December 4th, 2019 Sight Diagnostics today announces U.S. Food and Drug Administration 510(k) clearance of its 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 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.

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. “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.”

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.”

About Sight Diagnostics

The faster we diagnose, the faster we can treat. Founded in 2011, Sight Diagnostics aims to improve health through fast and pain-free diagnostic testing.

Sight’s latest blood analyzer, OLO, performs a Complete Blood Count, the most commonly ordered blood test, in minutes. It’s compact: designed to be used in a variety of settings.

Sight’s method, developed over almost a decade of research, represents an advance in diagnostic methodology. Sight’s analyzers create a digital version of your blood, by capturing around 1,000 highly detailed images from just two drops; these images are then interpreted by proprietary and fully automated algorithms. Sight’s first product was focused on detecting Malaria. It has been used in 24 countries and has delivered almost 1 million tests to date. 

At Sight, exceptional individuals work together to achieve extraordinary things. The company has rapidly growing offices in London, the US and Tel Aviv. 

Learn more at sightdx.com.

Contact Information

Emma Baron for Sight Diagnostics

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