Overview
ISO/TS 24932:2026 specifies procedures for the similarity calculation of gene expression profiles between human pluripotent stem cell (hPSC)-derived organoids and pre-defined datasets of gene expression in normal human tissues. As the field of regenerative medicine and organoid research advances, there is a growing need for reliable and standardized methods to quantitatively compare the molecular fidelity of laboratory-grown organoids to actual human organs. This technical specification aims to bring consistency and reproducibility to the process of transcriptome-based similarity analyses, using panel-based gene expression data.
This standard is intended for research and bioinformatics applications and is not designed for use in clinical or medical decision-making.
Key Topics
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Gene Expression Data Processing
ISO/TS 24932:2026 details procedures for selecting and processing gene expression (RNA-seq) data. Key steps include obtaining gene expression datasets from public resources (such as the GTEx database), ensuring data compatibility, and filtering out irrelevant or low-quality data types (e.g., sex-specific tissues, blood cells).
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Organ-Specific Gene Panels
The standard outlines methods for constructing organ-specific gene expression panels (Organ-GEPs) to enable targeted similarity calculations. This includes criteria for protein-coding gene selection, statistical filtering for differential expression, and normalization techniques.
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Similarity Calculation Algorithms
Guidance is provided for designing computation algorithms that yield quantifiable similarity scores. The methodology supports the use of standard normalization protocols (such as TPM values) and statistical programming tools, ensuring adaptability across research environments.
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RNA-Seq Data Quality Requirements
To maintain high-quality analyses, the document specifies minimum RNA integrity numbers (RIN), sequencing depth, and read quality controls for RNA sequencing experiments feeding into similarity assessments.
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Data Management and Reproducibility
Recommendations emphasize the importance of recording metadata (instrument models, read lengths, software versions) to support reproducibility and traceability in genomics informatics workflows.
Applications
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Organoid Validation in Research
By applying the prescribed procedures, research laboratories can objectively evaluate how closely hPSC-derived organoids resemble their target human tissues, supporting advances in regenerative medicine, drug testing, and disease modeling.
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Development of Analytical Tools
The standard serves as a foundation for computational platforms and web-based analytics systems that automate transcriptome similarity calculations, benefiting genomics researchers globally.
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Quality Assessment and Benchmarking
Researchers can benchmark new organoid differentiation protocols or samples against established tissue reference panels, enhancing cross-study comparability and quality control.
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Training and Education
ISO/TS 24932:2026 provides clear guidelines for constructing and applying gene expression panels, making it useful in training contexts for emerging scientists in genomics informatics.
Related Standards
ISO/TS 24932:2026 is part of a wider ecosystem of genomics and biotechnology standards. Entities engaging with this standard often reference the following documents for complementary guidance:
- ISO/TS 22690:2021 – Genomics informatics - Reliability assessment criteria for high-throughput gene-expression data
- ISO 24603:2022 – Biotechnology - Biobanking - Requirements for human and mouse pluripotent stem cells
- ISO 21474-1:2020 – In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Terminology and general requirements
- GTEx Portal – Public database for gene expression profiles in human tissues
Adopting ISO/TS 24932:2026 supports alignment with internationally recognized practices in genomics informatics, organoid research, and transcriptome analysis methodologies.
For further information and implementation assistance, stakeholders are encouraged to consult ISO and technical committee resources.
