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IARC 60th Anniversary - 19-21 May 2026

Session : 19/05/26 - Posters

Implementation of Digital Pathology in a Resource-Limited Setting: Operational Challenges and Diagnostic Concordance in Breast Carcinoma.

RAO S. 1, SHERPA M. 1, NAG D. 1

1 Department of Pathology, Sikkim Manipal Institute of Medical Sciences, GANGTOK, India

Background: The integration of Digital Pathology (DP) and Whole Slide Imaging (WSI) represents a significant technological advancement in diagnostic medicine. However, implementing this infrastructure in resource-limited environments presents distinct operational challenges compared to well-funded academic centres. The primary barriers include the substantial capital required for high-throughput scanners and the recurring costs of digital storage for massive image files. Operational workflows are further complicated by the technical intolerance of WSI scanners toward pre-analytical variables. Unlike Manual Light Microscopy (MLM), where human adaptation can compensate for tissue irregularities, scanners frequently fail to focus on sections containing adipose tissue, folds, or variable thickness artifacts. These issues necessitate frequent rescanning, creating bottlenecks that question the efficiency of the technology in high-volume, low-resource settings. Despite these hurdles, DP offers transformative advantages: the creation of non-degrading life-long archives, the elimination of physical slide transport, and the democratization of expert consultation through tele-pathology, removing the need for onsite examination. 

Objectives: This study aimed to evaluate the operational feasibility of establishing a digital pathology workflow within a resource-limited infrastructure. Specifically, it sought to validate the diagnostic accuracy of WSI by comparing it directly to the gold standard of MLM in the morphological diagnosis, grading, and biomarker scoring of breast carcinoma.

Methods: A cohort of 100 cases diagnosed as Invasive Carcinoma of the Breast (No Special Type) was selected for comparative analysis. The dataset included haematoxylin and eosin (H&E) stained slides for histological grading and immunohistochemistry (IHC) stained slides for Oestrogen Receptor (ER), Progesterone Receptor (PR), Her 2 neu, and Ki-67. A double-blinded study design was utilized involving three independent pathologists. The reviewers first evaluated the glass slides using standard MLM. After a washout period to minimize recall bias, the same cases were reviewed using digitized WSI scans. Concordance was assessed for final diagnosis, Modified Nottingham Histologic Score, and IHC biomarker scoring (specifically Allred scoring and Her 2 intensity).

?Results: The study demonstrated high diagnostic concordance between the digital and manual modalities. For H&E assessment, the final diagnosis and Modified Nottingham Histologic Score achieved 100% agreement across all 100 cases. Hormonal receptor evaluation (ER/PR) via Allred scoring showed strong comparability; minor discrepancies in staining intensity were noted in three cases but did not impact the final clinical score.However, Her 2 assessment revealed notable divergences in three cases classified as equivocal or positive. In two instances, cases scored as equivocal (Score 2) on manual microscopy were upgraded to positive (Score 3) on digital review. Conversely, one case was downgraded from positive to equivocal upon digital inspection.

?Conclusion: While the transition to digital pathology in resource-limited settings is hindered by high costs and stringent requirements for pre-analytical standardization, the diagnostic utility of WSI is non-inferior to manual microscopy for breast carcinoma. The observed upgrade in Her 2 scoring suggests that digital monitors may enhance contrast perception, potentially necessitating calibrated thresholds for "digital" biomarker interpretation.  Ultimately, the capacity for remote second opinions and digital archiving outweigh the operational "cons," making DP a vital for modernizing pathology services in developing healthcare system.