Summary

In bone biopsy specimens decalcification is a mandatory practice before tissue processing. In the era of precision medicine, the available decalcification reagents often affect nucleic acids, compromising molecular characterizations required in case of bone metastasis. Moreover, decalcification lacks homogenized and standardized protocols, leading to a complex management and high inter- and intra-laboratory variability. These issues represent a main challenge for molecular profiling because testing failure may deny access to personalized therapies. The objective of this study was to compare the effect of a new ready-to-use EDTA-based CE-IVD decalcification agent (Microdec®) with other available decalcification reagents on histomolecular analyses. Interestingly, we found that Microdec® outperforms other evaluated agents and tissues treated with Microdec® are comparable with non-decalcified formalin fixed ones in terms of nucleic acid (DNA and RNA) concentration and fragmentation index allowing optimal results for molecular analyses. In addition, we explored the impact of Microdec® on immunohistochemistry demonstrating that it does not significantly affect protein characterization for diagnostics and predictive purposes. Overall, the carful choice of decalcification agents allows the eligibility of bone biopsy for molecular and predictive pathology without affecting morphology.

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Lorenzo Nibid - Research Unit of Anatomical Pathology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy. https://orcid.org/0000-0001-8583-0596

Luca Andreotti - Research Unit of Anatomical Pathology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy

Christian Brunetti - Anatomical Pathology Operative Research Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy

Emanuele Esposito - Anatomical Pathology Operative Research Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Via Alvaro del Portillo, 200, 00128 Roma, Italy

Daniela Righi - Research Unit of Anatomical Pathology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Roma, Italy

Carmelo Lupo - Innovation Department, Diapath StatLab Company, Martinengo, Italy

Nadia Casatta - Innovation Department, Diapath StatLab Company, Martinengo, Italy

Chiara Taffon - Research Unit of Anatomical Pathology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy

Giuseppe Perrone - Research Unit of Anatomical Pathology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Via Alvaro del Portillo, 21, 00128 Roma, Italy. https://orcid.org/0000-0002-9538-5729

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Copyright (c) 2026 Società Italiana di Anatomia Patologica e Citopatologia Diagnostica, Divisione Italiana della International Academy of Pathology

How to Cite
Nibid, L., Andreotti, L., Brunetti, C., Esposito, E., Righi, D., Lupo, C., Casatta, N., Taffon, C., & Perrone, G. (2026). Performance evaluation of a new EDTA-based CE-IVD decalcifying agent on predictive markers for precision medicine. Pathologica - Journal of the Italian Society of Anatomic Pathology and Diagnostic Cytopathology, 118(4). https://doi.org/10.32074/1591-951X-1230
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