FDA delivers de novo clearance to Scopio's bone marrow pathology AI for blood disorders, cancer

Scopio Labs has received a de novo clearance from the FDA for its artificial-intelligence-powered system that analyzes bone marrow biopsies to help diagnose a range of blood disorders, including cancer.

The company’s all-digital cell morphology analysis platform employs high-resolution microscopic imaging of samples taken through bone marrow aspiration procedures and automatically highlights different hematopoietic cell types in stained blood smears. 

Scopio said its application can assist trained pathologists and remote users in evaluating cell quality and estimating counts of blasts and plasma cells—traditionally labor-intensive processes involving the careful differential review of hundreds of cells per sample.

“By optimizing digital workflows and enabling unique remote review of entire smears, we are hopeful this technology can help enhance efficiency across the board,” said Adam Bagg, M.D., lead investigator of the company’s study submitted for FDA review and a professor of pathology and laboratory medicine at the University of Pennsylvania’s Perelman School of Medicine.

Scopio estimates that blood cancers account for about 10% of all diagnosed cancers in the U.S., with accurate bone marrow aspirate biopsies playing a crucial role in identifying both malignant and benign conditions.

The company’s FF-BMA software integrates with its X100 and X100HT slide analysis instruments to link full-field imaging with the application’s decision support system. The program received a CE mark approval in Europe in late 2022.

Siemens Healthineers signed up last year to globally distribute the digital X100 and X100HT systems, designed to replace manual microscopes. Scopio’s lab hardware is designed to sit next to hematology analyzers, where, if a sample shows any abnormalities, a blood smear can be quickly prepared and transferred to the company’s slide imagers.