Digital system augmented by artificial intelligence to interpret bone marrow samples for hematological disease diagnosis

Abstract

Analysis of bone marrow aspirates (BMA) is an essential step in the diagnosis of hematological disorders. This analysis is usually performed based on visual examination of the samples under a conventional optical microscope, which involves a labor-intensive process, limited by clinical experience and subject to high observer variability. In this work, we present a comprehensive digital system that enables BMA analysis for cell type counting and differentiation in an efficient and objective manner. This system not only provides an accessible and simple method to digitize, store and analyze BMA samples remotely, but is also supported by an artificial intelligence (AI) pipeline that accelerates the differential cell counting (DCC) process and reduces inter-observer variability. It has been designed to integrate AI algorithms with the daily clinical routine and can be used in any regular hospital workflow.

Competing Interest Statement

DB-P, SRC, AMU, EA, LL, ED, DC, MP, AV, JG-V, MJL-C, AS, ML and MLO hold shares or phantom shares of Spotlab. The rest of the authors declare no conflict of interest.

Funding Statement

This project has received funding from the European Union Horizon 2020 research and innovation program under grant agreement No 881062. DB-P was supported by grant PTQ2020-011340/AEI/10.13039/501100011033 funded by the Spanish State Investigation Agency. RG-V holds a Formacion de Profesorado Universitario (FPU19/04933) grant from the Ministry of Science, Innovation and Universities of Spain Government. AR-G holds the FEHH 2021 research grant from the Spanish Society of Hematology. LL was supported by a predoctoral grant IND2019/TIC-17167 (Comunidad de Madrid, Spain).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for the study was obtained from the Hospital 12 de Octubre Ethics Committee for Research with medicinal products (Num. Ref. 20/430). This study was conducted in accordance with the Declaration of Helsinki, all samples used in this study were anonymized according to local guidelines and informed consent was obtained from all subjects.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

For data sharing requests, please contact Miguel Luengo-Oroz (miguel@spotlab.ai)

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