The dream of a comfortable, tabletop blood testing device, one needing only a few drops taken from a finger and a handful of minutes, has now arrived in the U.S.—and this time carrying an official FDA clearance.
Sight Diagnostics received a 510(k) green light from the agency for its OLO analyzer, allowing it to provide lab-grade results for the common complete blood count test in hospitals, clinics and elsewhere.
The compact device uses digital microscopes to visually tally the number of red blood cells, white blood cells and platelets found in a sample to provide physicians with a quick overview of a patient’s general health. The panel is included in over 90% of baseline blood tests.
“The CBC is frequently used as a data point in determining whether an ailment is viral or bacterial,” said Carlo Brugnara, director of the hematology lab at Boston’s Children’s Hospital, where U.S. clinical trials of the OLO device were conducted in part.
The OLO has been commercially available in Europe and other international markets since it obtained a CE mark in July 2018. Currently, it’s being evaluated by Oxford University Hospital Trust and will also form the base of a pilot blood testing program with the U.K. pharmacy chain Superdrug, according to Sight. The company also said it is working to establish partnerships in Africa, Asia and South America.
“In rarer cases––involving acute leukemia, for instance––a CBC can make the difference between life and death,” added Brugnara, who also serves as professor of pathology at Harvard Medical School.
Going forward, Sight plans to pursue an FDA waiver from CLIA laboratory regulations to certify OLO’s use in smaller U.S. practices and pharmacies.
“The years our R&D team spent solving complex engineering and design challenges have positioned us well to expand our offering in the future,” the Israeli startup’s chief technology officer, Sarah Levy, said in a statement.
“Our end-goal is to offer diagnostics for any disease with visible signatures in the bloodstream,” Levy said. “We are confident Sight can continue to improve patient outcomes through new, faster, less costly and more convenient testing.”
The OLO device and its artificial intelligence-based technology got its start screening tens of thousands of blood samples for signs of malaria using digital fluorescent microscopy. The company’s algorithms draw from nearly half a petabyte of blood image data collected over five years of clinical work.