Scopio Labs Gets FDA Clearance for Digital Bone Marrow Aspirate Application
The developer of full-field digital cytomorphology imaging™ and analysis platforms and a leader in the field of digital morphology, Scopio Labs, announced today that its Full-Field Bone Marrow Aspirate™ (FF-BMA) has received FDA De Novo clearance.
Bone marrow cytomorphology, the microscopic analysis of cells in bone marrow samples, remains a vital diagnostic tool for various blood diseases. Malignant hematological neoplasms account for about 10% of all diagnosed cancers in the United States and continue to be a leading cause of the global cancer burden. Bone marrow aspiration (BMA) plays a critical role in diagnosing these and other hematological diseases (including malignant and benign conditions). However, traditional manual methods are labor-intensive, time-consuming, and heavily depend on experienced hematopathologists to ensure accuracy.
Scopio’s FF-BMA application transforms BMA analysis by introducing a fully digitalized workflow that seamlessly integrates with Scopio’s X100 and X100HT platforms. It automatically detects and visualizes hematopoietic cells in stained smears, facilitating the progress of various assessment items such as bone marrow smear quality assessment, primitive cells and plasma cell estimation, and the calculation of the myeloid to erythroid (M:E) ratio.
By combining high-resolution full-field imaging with an artificial intelligence decision support system (DSS), the solution aims to greatly benefit healthcare professionals and patients. It allows hematopathologists to remotely access and review bone marrow smears (via secure hospital networks), thereby shortening turnaround times and enhancing diagnostic accuracy.
Although the concept of AI pathology is well-established, this product is the first in the United States to offer a complete digital workflow for BMA examinations.
In 2023, the Fudan Zhongshan detection team collaborated with the domestically developed Morphogo automatic scanning platform to design a 27-layer neural network for the recognition of bone marrow cells and metastatic cancer cell clusters. The team made a preliminary exploration of the clinical application of AI in MCBM screening and diagnosis, with their findings published in Frontiers in Oncology (IF:6.24). Results showed that by combining manual and AI-based rapid screening for suspicious cell clusters in all bone marrow smears, followed by expert morphological review and diagnosis, the efficiency of detecting cancer cell clusters could be significantly improved, meeting the basic requirements for disease screening (specificity 65.5%; negative predictive value 94.6%). However, a mature product benchmarking bone marrow smears has yet to emerge in the domestic market. This approval fills a gap in the U.S. market, and digital BMA examination may become the next hot direction in the AI pathology field.
About Scopio Labs
Scopio Labs, an Israeli startup, is a developer of full-field digital imaging dedicated to hematology diagnostics, having raised $50 million in Series C funding in 2022. Scopio addresses the long-standing trade-off between resolution and field of view in cell morphology. Its high-resolution imaging combined with embedded AI enables more efficient remote workflows, facilitating better diagnostics throughout the care process.
Scopio Labs’ applications for peripheral blood smears and bone marrow aspirates have received FDA approval and the CE mark, and can be used with the Scopio X100 and Scopio X100HT platforms. Several industry giants have recognized the considerable potential of its products and have chosen to collaborate with it.
In May 2022, Beckman Coulter announced a global partnership with Scopio Labs, adopting Scopio’s next-generation platform for peripheral blood smears. Scopio’s devices capture large scanning areas at a 100x magnification. The Scopio X100HT can accommodate 30 slides, processing up to 40 samples per hour, meeting the high-throughput requirements of large hospitals and laboratories.
In May 2023, Siemens announced that the Scopio X100 and X100HT imaging platforms would complement its IVD systems, including the Atellica Hema 570 and Atellica Hema 580 analyzers. Siemens endorsed that Scopio’s application for peripheral blood smears has been proven to reduce examination turnaround times by 60%. This was demonstrated in a study at the Sourasky Medical Center in Tel Aviv, where it was found that the turnaround time for peripheral blood smear analysis was reduced by more than 40% on weekends and by 59% on the first working day.
