FDA Approves AI Technology for Detecting Cancer Indicators in Bone Marrow

The U.S. Food and Drug Administration (FDA) has granted approval for an innovative AI-powered diagnostic tool that enhances the detection of cancer in blood samples. Developed by Scopio Labs, the Full-Field Bone Marrow Aspirate (FF-BMA) tool is specifically designed to assist clinicians in analyzing bone marrow samples more swiftly and effectively.

Bone marrow, the soft tissue residing within bones, plays a critical role in producing blood cells. By examining bone marrow, medical professionals can identify potential cancers, notably types such as leukemia and lymphoma. Notably, hematologic malignancies represent approximately 10% of all cancer diagnoses in the United States, underscoring the importance of timely and accurate diagnostics.

Traditional bone marrow analysis can be labor-intensive and often requires the expertise of specialized doctors known as hematopathologists. Scopio Labs' AI technology aims to revolutionize this process by facilitating quicker and more reliable diagnostic outcomes. The FF-BMA tool automates the detection and visualization of hematopoietic cells, enabling doctors to access AI-analyzed samples for faster and more precise diagnoses.

The workflow begins when patient samples are placed into a hematology analyzer. Upon detecting any anomalies, a blood smear is prepared, and the sample is transferred to Scopio’s advanced imaging platform, known as the X100. This platform not only allows for high-quality imaging of the samples but also enables secure sharing of these scans with off-site colleagues and hematopathologists, fostering remote collaboration. Such capabilities ensure that clinicians can obtain expert second opinions, honing the diagnostic process and improving overall accuracy.

Having received De Novo clearance, Scopio’s FF-BMA tool is now officially available for use by healthcare providers. Itai Hayut, CEO of Scopio Labs, expressed gratitude towards the FDA for recognizing the critical need to support hematology professionals in their intricate work. He noted that the approval empowers these experts with robust decision support systems, thereby streamlining laboratory workflows, reducing operational costs, and ultimately enhancing patient care.

Adam Bagg, a pathology professor at the University of Pennsylvania and the lead investigator on Scopio’s FDA study, emphasized the significance of this advancement: "Scopio’s FF-BMA application meets the urgent demand for digital innovation in response to the growing prevalence of hematologic conditions and the ever-increasing demands on healthcare. By optimizing digital workflows and facilitating unique remote reviews of entire smear samples, we anticipate this technology will significantly boost efficiency across the healthcare spectrum."

Founded in 2015 by Hayut and Erez Na’aman, Scopio Labs recently formed a partnership with Siemens Healthineers to broaden the distribution of its pioneering AI-powered hematology detection tool, further enhancing its reach and impact in the medical field.