FDA Clears AI Tool for Detecting Cancer Signs in Bone Marrow

The U.S. Food and Drug Administration (FDA) has approved an AI-powered diagnostic tool that can identify signs of cancer in blood samples.

Scopio Labs’ Full-Field Bone Marrow Aspirate (FF-BMA) tool is designed to help clinicians analyze bone marrow samples faster.

Bone marrow, a soft tissue found inside bones, produces blood cells. Clinicians can analyze bone marrow to detect potential types of cancer, like leukemia and lymphoma.

Hematologic malignancies, as found in blood samples, account for around 10% of all diagnosed cancers in the U.S., according to Scopio Labs.

Traditionally, bone marrow analysis is a time-consuming process and requires input from specialized doctors called hematopathologists.

The Israel-based company’s AI tool was built to enhance patient care by enabling faster and more reliable diagnostic processes.

Scopio’s FF-BMA tool is designed to speed up diagnoses by automating the detection and visualization of hematopoietic cells. Doctors can then view the AI-analyzed samples and make a diagnosis faster and more accurately.

Credit: Scopio Labs

Patient samples are placed into a hematology analyzer. Once the AI-powered tool detects an anomaly, a blood smear is scheduled with the sample transferred to Scopio’s imaging platform, the X100.

The company’s imaging platform allows clinicians to securely share sample scans with off-site colleagues and hematopathologists, allowing for remote collaboration, expert second opinions and a more comprehensive and accurate diagnostic process.

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Having received De Novo clearance, the FF-BMA tool is now cleared for use by health care providers.

"We commend the FDA for acknowledging the essential need to support hematology experts in their complex work," said Itai Hayut, Scopio Labs’ CEO. "The approval of the FF-BMA Application arms them with robust decision support systems. By harnessing AI and Full-Field imaging, labs can streamline workflows, reduce operational costs and enhance patient care."

"Scopio's FF-BMA application addresses the urgent need for digital innovation amid the rising prevalence of hematologic conditions and health care demands," said Adam Bagg, a pathology professor from the University of Pennsylvania and the lead investigator in Scopio’s study that was submitted to the FDA.

"By optimizing digital workflows and enabling unique remote review of entire smears, we are hopeful this technology can help enhance efficiency across the board."

Scopio was founded in 2015 by Hayut and Erez Na’aman. The company recently announced a partnership with Siemens Healthineers to distribute its AI-powered hematology detection tool to customers.

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