{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T18:02:24Z","timestamp":1789408944300,"version":"build-2803163510"},"reference-count":229,"publisher":"MDPI AG","issue":"18","license":[{"start":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T00:00:00Z","timestamp":1789344000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"University of Oradea"},{"id":[{"id":"https:\/\/ror.org\/00wzhv093","id-type":"ROR","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Molecular pathology-driven oncologic diagnostics\u2014genomic profiling, transcriptomics, proteomics, and, increasingly, artificial intelligence applied to tissue and liquid biopsy\u2014can only be as accurate as the biospecimens on which they are performed. Biobanks are the infrastructures that secure this foundation, linking donors, biological samples, and data to discovery and, through the pathology interface, back to diagnosis. Their scientific and diagnostic value, however, is determined less by the number of specimens stored than by the rigor of the guidelines under which those specimens are collected, processed, annotated, governed, and shared. The normative landscape has changed considerably in the last three years: the ISBER Best Practices reached their fifth edition (2023), the NCI Best Practices were comprehensively revised (2026), the Standard PREanalytical Code (SPREC) was updated to version 4.0 (2024\/2025), MIABIS Core reached version 3.0 (2024), the 2024 revision of the Declaration of Helsinki explicitly anchored biobank governance to the Declaration of Taipei, the European Health Data Space Regulation (EU) 2025\/327 entered into force, and ISO 20387\u2014the accreditation standard for biobanks\u2014is undergoing its first full revision. This review synthesizes the current (2026) status of international biobanking standards, ethical and legal frameworks, pre-analytical and quality management requirements, data and interoperability standards, and sustainability models, drawing on more than 200 sources with emphasis on the 2023\u20132026 literature. Standards are presented not as an inventory but as an operational system, organized along the biobanking workflow from donor consent to sample distribution and impact tracking. On this basis, we propose a phased, guideline-anchored roadmap and a start-up checklist to help new teams establish a real-world biobank\u2014particularly hospital-integrated biobanks in settings without a mature national biobanking infrastructure\u2014and we review comprehensively the financial, operational, regulatory, and societal challenges that determine whether a new biobank thrives or stalls. Particular attention is given to the specimen classes and quality controls on which molecular tumor diagnostics depend\u2014FFPE tissue and its sequencing artifacts, fresh-frozen tissue, liquid biopsy analytes, and DV200-gated derivative quality\u2014and to the interface between research biobanking and the accredited diagnostic laboratory, which is set out explicitly because the two are governed by different standards. We further provide explicit, endpoint-specific operational control of warm and cold ischemia, a quality-control framework for advanced patient-derived models (xenografts and organoids) and their interface with dedicated model cores, an explicit statement of the evidence underlying the practical recommendations, and a dedicated limitations section. The review is intended as a reference piece for biobankers, pathologists, clinician-researchers, quality managers, and institutional decision-makers building the biobanks on which the coming decade of precision oncology will depend.<\/jats:p>","DOI":"10.3390\/cancers18182974","type":"journal-article","created":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T17:01:00Z","timestamp":1789405260000},"page":"2974","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["From Donor to Discovery and Diagnosis: A Comprehensive 2026 Review of International Biobanking Guidelines Underpinning Molecular Pathology-Driven Cancer Diagnostics, with a Practical Roadmap for Establishing a New Biobank"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5219-5466","authenticated-orcid":false,"given":"Andreea-Adriana","family":"Neam\u021bu","sequence":"first","affiliation":[{"name":"Department of Toxicology, Faculty of Pharmacy, \u201cVictor Babe\u0219\u201d University of Medicine and Pharmacy, Eftimie Murgu Square, No. 2, 300041 Timi\u0219oara, Romania"},{"name":"Research Centre for Pharmaco-Toxicological Evaluation, Faculty of Pharmacy, \u201cVictor Babe\u0219\u201d University of Medicine and Pharmacy, Eftimie Murgu Square, No. 2, 300041 Timi\u0219oara, Romania"},{"name":"Department of Pathology, Clinical County Emergency Hospital of Arad, Andrenyi Karoly Str., No. 2-4, 310037 Arad, Romania"},{"name":"Department of Pathology, \u201cPius Br\u00eenzeu\u201d Clinical County Emergency Hospital, Liviu Rebreanu Boulevard, No. 156, 300723 Timi\u0219oara, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4634-969X","authenticated-orcid":false,"given":"Robert","family":"Barna","sequence":"additional","affiliation":[{"name":"Department of Pathology, \u201cPius Br\u00eenzeu\u201d Clinical County Emergency Hospital, Liviu Rebreanu Boulevard, No. 156, 300723 Timi\u0219oara, Romania"},{"name":"ANAPATMOL Research Center, Faculty of Medicine, \u201cVictor Babe\u0219\u201d University of Medicine and Pharmacy Eftimie Murgu Square, No. 2, 300041 Timi\u0219oara, Romania"},{"name":"Department of Microscopic Morphology\u2014Anatomic Pathology, Faculty of Medicine, \u201cVictor Babe\u0219\u201d University of Medicine and Pharmacy, Eftimie Murgu Square, No. 2, 300041 Timi\u0219oara, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2923-6813","authenticated-orcid":false,"given":"Alon","family":"Vigdorovits","sequence":"additional","affiliation":[{"name":"Doctoral School of Biomedical Sciences, University of Oradea, Universit\u0103\u021bii Str., No. 1, 410087 Oradea, Romania"},{"name":"Department of Anatomic Pathology, Clinical County Emergency Hospital Bihor, Gheorghe Doja Str., No. 65, 410169 Oradea, Romania"},{"name":"Department of Morphological Disciplines, Faculty of Medicine and Pharmacy, University of Oradea, Universit\u0103\u021bii Str., No. 1, 410087 Oradea, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iulian-Andrei","family":"Hotinceanu","sequence":"additional","affiliation":[{"name":"Genekor Medical, Nicolae G. Caramfil Str., No. 53, 077190 Bucharest, Romania"},{"name":"Department of Medical Genetics, \u201cCarol Davila\u201d University of Medicine and Pharmacy, Dionisie Lupu Str., No. 37, 020021 Bucharest, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihaela-Mirela","family":"Muresan","sequence":"additional","affiliation":[{"name":"Doctoral School of Biomedical Sciences, University of Oradea, Universit\u0103\u021bii Str., No. 1, 410087 Oradea, Romania"},{"name":"Department of Anatomic Pathology, Clinical County Emergency Hospital Bihor, Gheorghe Doja Str., No. 65, 410169 Oradea, Romania"},{"name":"Department of Morphological Disciplines, Faculty of Medicine and Pharmacy, University of Oradea, Universit\u0103\u021bii Str., No. 1, 410087 Oradea, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5342-0311","authenticated-orcid":false,"given":"Andrei-Vasile","family":"Pascalau","sequence":"additional","affiliation":[{"name":"Department of Anatomic Pathology, Clinical County Emergency Hospital Bihor, Gheorghe Doja Str., No. 65, 410169 Oradea, Romania"},{"name":"Department of Morphological Disciplines, Faculty of Medicine and Pharmacy, University of Oradea, Universit\u0103\u021bii Str., No. 1, 410087 Oradea, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ovidiu-Laurean","family":"Pop","sequence":"additional","affiliation":[{"name":"Doctoral School of Biomedical Sciences, University of Oradea, Universit\u0103\u021bii Str., No. 1, 410087 Oradea, Romania"},{"name":"Department of Anatomic Pathology, Clinical County Emergency Hospital Bihor, Gheorghe Doja Str., No. 65, 410169 Oradea, Romania"},{"name":"Department of Morphological Disciplines, Faculty of Medicine and Pharmacy, University of Oradea, Universit\u0103\u021bii Str., No. 1, 410087 Oradea, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,14]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"172","DOI":"10.1186\/s12967-019-1922-3","article-title":"Biobanking in Health Care: Evolution and Future Directions","volume":"17","author":"Coppola","year":"2019","journal-title":"J. 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