FDA has granted premarket notification (510(k)) clearance to the Olo analyzer from Sight Diagnostics, Tel Aviv, Israel, for use in the United States. The analyzer performs a complete blood count (CBC) with lab-grade results in minutes, using just a few drops of blood from a fingerstick or venous sample. The analyzer is compact and easy to use, and it can reduce costs in low-volume settings.

FDA clearance follows clinical trials performed at Boston Children’s Hospital, Columbia University Medical Center, and Tricore Labs. Agency clearance permits use of the Olo analyzer in laboratories run by hospitals, diagnostic providers, and outpatient clinics.

Carlo Brugnara, MD, Boston Children's Hospital.

Carlo Brugnara, MD, Boston Children’s Hospital.

CBC testing enumerates and characterizes the number of red blood cells, white blood cells, and platelets in a patient’s blood sample, and is one of the most basic, informative tests a doctor can perform.

“The CBC is frequently used as a data point in determining whether an ailment is viral or bacterial,” says Carlo Brugnara, MD, professor of pathology at Harvard Medical School and director of the hematology lab at Boston Children’s Hospital. “In rarer cases—involving acute leukemia, for instance—a CBC can make the difference between life and death.”

Steven Melnick, MD, PhD, Nicklaus Children Hospital.

Steven Melnick, MD, PhD, Nicklaus Children Hospital.

The Olo analyzer’s compact size means that it may be attractive in clinical settings that don’t require high-volume laboratory equipment. “To treat children in our urgent care centers, a CBC is essential. Olo represents a major innovation in our laboratories’ CBC analysis, introducing fingerstick and venous sampling, five-part differential, and flagging. It’s a truly welcome development,” says Steven Melnick, MD, PhD, chief of pathology at Miami’s Nicklaus Children Hospital, which is evaluating the technology. “At current volumes, we believe Olo will substantially reduce our costs.”

The Olo analyzer is already commercially available in Europe and other international markets and is in use at renowned institutions such as Oxford University Hospital, which is currently evaluating Olo in both its surgical emergency unit and oncology clinic. Sight Diagnostics is also establishing partnerships in Africa, Asia, and South America, in addition to its growing offices in Israel, the United Kingdom, and the United States.

Sarah Levy, Sight Diagnostics.

Sarah Levy, Sight Diagnostics.

Sight Diagnostics has been granted six US patents related to technological innovations embodied in the Olo analyzer, with more pending. In the future, Sight intends to pursue a CLIA waiver from FDA, to certify Olo for use in smaller medical 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, CTO at Sight Diagnostics. “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.”

For more information, visit Sight Diagnostics.