Academic trend at home and abroad

Application prospects of organoids and interpretation of domestic and international policies

  • YU Yingyan
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  • Department of General Surgery, Ruijin Hospital, Shanghai Institute of Digestive Surgery, and Shanghai Key Laboratory for Gastric Neoplasms, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China

Received date: 2025-12-28

  Revised date: 2026-01-29

  Accepted date: 2026-03-03

  Online published: 2026-04-25

Abstract

Organoids are a three-dimensional (3D) in vitro culture technology developed in recent years, in which a portion of living tissue is expanded and passaged in a 3D culture medium to generate miniature organs. Organoids share a high degree of similarity with their parental tissues in terms of cellular composition, biological functions, genomic variation profiles, and drug sensitivity. Organoids have a short preparation cycle and can still be used after long-term cryopreservation and recovery, and are therefore referred to as "living biobanks". Organ-on-chip, also known as organoid chip, is a microphysiological system (MPS) that integrates organoid construction with microfluidic chips or microplate technology, in which organoids are seeded onto microfluidic devices or microplates, and can serve as a novel experimental model for drug sensitivity analysis and drug screening. Organoids and organ-on-chip have broad application prospects in histogenesis, disease pathogenesis, compound toxicology, response to drug treatment, and high-throughput drug screening. Tumor research is an important application area for organoids and organ-on-chip. In recent years, countries in Europe and the United States have introduced a series of policies and regulations to promote the application of organoids and organ-on-chip, aiming to gradually reduce reliance on experimental animals in scientific research and drug development. The Ministry of Science and Technology of China and the National Natural Science Foundation of China have also identified the construction and application of organoid models as an important funding direction. With the continuous improvement of regulatory policies related to organoids, the healthy and orderly development of organoid-related technologies in China will be further promoted.

Cite this article

YU Yingyan . Application prospects of organoids and interpretation of domestic and international policies[J]. Journal of Diagnostics Concepts & Practice, 2026 , 25(02) : 157 -164 . DOI: 10.16150/j.1671-2870.2026.02.006

References

[1] SATO T, VRIES R G, SNIPPERT H J, et al. Single Lgr5 stem cells build crypt-villus structures in vitro without a mesenchymal niche[J]. Nature, 2009, 459(7244):262-265.
[2] YANG R, YU Y. Patient-derived organoids in translational oncology and drug screening[J]. Cancer Lett, 2023,562:216180.
[3] 中国抗癌协会. 人胃癌类器官构建、质量控制与保藏团体标准[J]. 中华消化外科杂志, 2024, 23(6):761-769.
  Chinese Anti-Cancer Association. Group standard for the construction, quality control, and preservation of human gastric cancer organoids[J]. Chin J Dig Surg, 2024, 23(6):761-769.
[4] 罗芳丽, 孙路强, 王司琦, 等. 肠道屏障功能评估技术的研究进展[J]. 重庆医科大学学报, 2025, 50(1):23-29.
  LUO F L, SUN L Q, WANG S Q, et al. Research progress on intestinal barrier function assessment techniques[J]. J Chongqing Med University, 2025, 50(1):23-29.
[5] 章新, 郑莹. 2005-2020年中国国家及分省疾病监测点的肿瘤死亡疾病负担数据解读[J]. 诊断学理论与实践, 2024, 23(4):371-377.
  ZHANG X, ZHENG Y. Interpretation of cancer death burden data from disease surveillance sites in China from 2005 to 2020[J]. J Diagn Concepts Pract, 2024, 23(4):371-377.
[6] LI B, TANG Y, HUANG Z, et al. Synergistic innovation in organ-on-a-chip and organoid technologies: Reshaping the future of disease modeling, drug development, and precision medicine[J]. Protein Cell,2025:pwaf058.
[7] DIJKSTRA K K, MONKHORST K, SCHIPPER L J, et al. Challenges in establishing pure lung cancer organoids limit their utility for personalized medicine[J]. Cell Rep, 2020, 31(5):107588.
[8] YANG R, QI Y, KWAN W, et al. Paired organoids from primary gastric cancer and lymphatic metastasis are useful for personalized medicine[J]. J Transl Med, 2024, 22(1):754.
[9] YAO Y, XU X, YANG L, et al. Patient-derived organoids predict chemoradiation responses of locally advanced rectal cancer[J]. Cell Stem Cell, 2020, 26(1):17-26.
[10] GANESH K, WU C, O’ROURKE K P, et al. A rectal cancer organoid platform to study individual responses to chemoradiation[J]. Nat Med, 2019, 25(10):1607-1614.
[11] XIANG Z, ZHOU Z, SONG S, et al. Dexamethasone suppresses immune evasion by inducing GR/STAT3 mediated downregulation of PD-L1 and IDO1 pathways[J]. Oncogene, 2021, 40(31):5002-5012.
[12] ZHOU G, LIESHOUT R, VAN TIENDEREN G S, et al. Modelling immune cytotoxicity for cholangiocarcinoma with tumour-derived organoids and effector T cells[J]. Br J Cancer, 2022, 127(4):649-660.
[13] DEKKERS J F, ALIEVA M, CLEVEN A, et al. Uncovering the mode of action of engineered T cells in patient cancer organoids[J]. Nat Biotechnol, 2023, 41(1):60-69.
[14] CHIRIACO C, DONINI C, CORTESE M, et al. Efficacy of CAR-T immunotherapy in MET overexpressing tumors not eligible for anti-MET targeted therapy[J]. J Exp Clin Cancer Res, 2022, 41(1):309.
[15] BERGDORF K, PHIFER C, BHARTI V, et al. High-throughput drug screening of fine-needle aspiration-derived cancer organoids[J]. STAR Protoc, 2020, 1(3):100212.
[16] DU Y, LI X, NIU Q, et al. Development of a miniaturized 3D organoid culture platform for ultra-high-throughput screening[J]. J Mol Cell Biol, 2020, 12(8):630-643.
[17] 陆雯雯, 周海霞, 庄剑波, 等. hnRNPA2B1介导m6A修饰MIR100HG促进胃癌MKN-28细胞增殖和侵袭作用[J]. 重庆医科大学学报, 2025, 50(8):1078-1083.
  LU W W, ZHOU H X, ZHUANG J B, et al. Effect of hnRNPA2B1-mediated m6A modification of MIR100HG in promoting the proliferation and invasion of gastric cancer MKN-28 cells[J]. J Chongqing Med Univ, 2025, 50(8):1078-1083.
[18] TANAKA M, KONDO J, KANEKO K, et al. Heterogenous chemosensitivity of a panel of organoid lines derived from small cell neuroendocrine carcinoma of the uterine cervix[J]. Hum Cell, 2021, 34(3):889-900.
[19] SAEKI S, KUMEGAWA K, TAKAHASHI Y, et al. Transcriptomic intratumor heterogeneity of breast cancer patient-derived organoids may reflect the unique biological features of the tumor of origin[J]. Breast Cancer Res, 2023, 25(1):21.
[20] HUO K G, D’ARCANGELO E, TSAO M S. Patient-derived cell line, xenograft and organoid models in lung cancer therapy[J]. Transl Lung Cancer Res, 2020, 9(5):2214-2232.
[21] SEIDLITZ T, MERKER S R, ROTHE A, et al. Human gastric cancer modelling using organoids[J]. Gut, 2019, 68(2):207-217.
[22] HOSHI D, KITA E, MARU Y, et al. Derivation of pancrea-tic acinar cell carcinoma cell line HS-1 as a patient-derived tumor organoid[J]. Cancer Sci, 2023, 114(3):1165-1179.
[23] YANG R, QI Y, ZHANG X, et al. Living biobank: Standardization of organoid construction and challenges[J]. Chin Med J, 2024, 137(24):3050-3060.
[24] 杨蕊馨, 于颖彦. 人工智能在消化道肿瘤医学图像数据处理的应用[J]. 诊断学理论与实践, 2025, 24(6):605-612.
  YANG R X, YU Y Y. Application of artificial intelligence in medical image data processing for digestive tract tumors[J]. J Diagn Concepts Pract, 2025, 24(6):605-612.
[25] YANG R, DU Y, KWAN W, et al. A quick and reliable image-based AI algorithm for evaluating cellular senescence of gastric organoids[J]. Cancer Biol Med,2023:1-18.
[26] 类器官药物敏感性检测指导肿瘤精准治疗临床应用专家共识(2022年版)编写专家组. 类器官药物敏感性检测指导肿瘤精准治疗临床应用专家共识(2022年版)[J]. 中国癌症防治杂志, 2022, 14(3):234-239.
  The expert group composed the expert consensus on the clinical application of organoid drug sensitivity testing to guide tumor precision therapy (2022 version). Expert consensus on the clinical application of organoid drug sensitivity testing to guide tumor precision therapy (2022 version)[J]. Chin J Oncol Prev Treat, 2022, 14(3):234-239.
[27] ESCOPETE S, ARZT M, MOZNEB M, et al. Human cardiac organoids for disease modeling and drug discovery[J]. Trends Mol Med, 2025.
[28] YANG N, CHEN J, ZHU Y, et al. Human cardiac organoid model reveals antibacterial triclocarban promotes myocardial hypertrophy by interfering with endothelial cell metabolism[J]. Sci Bull, 2025, 70(3):342-346.
[29] XU X, ZHANG Y, GENG Y, et al. Organoids: Their emerging essential role in pathological mechanisms and drug discovery of diabetes and its complications[J]. Front Pharmacol, 2025,16:1650200.
[30] QOSA H, RIBEIRO A J S, HARTMAN N R, et al. Cha-racterization of a commercially available line of iPSC hepatocytes as models of hepatocyte function and toxicity for regulatory purposes[J]. J Pharmacol Toxicol Meth, 2021,110:107083.
[31] GANGWAL A, LAVECCHIA A. Artificial intelligence in preclinical research: Enhancing digital twins and organ-on-chip to reduce animal testing[J]. Drug Discov Today, 2025, 30(5):104360.
[32] 王俊龙, 傅丽霞, 王青洋, 等. 类器官技术在新药评价中的应用进展[J]. 中国新药杂志, 2024, 33(20):2131-2137.
  WANG J L, FU L X, WANG Q Y, et al. Progress in application of organoids technique in new drug evaluation[J]. Chin J New Drug, 2024, 33(20):2131-2137.
[33] WADMAN M. FDA no longer has to require animal tes-ting for new drugs[J]. Science, 2023, 379(6628):127-128.
[34] STRESSER D M, KOPEC A K, HEWITT P, et al. Towards in vitro models for reducing or replacing the use of animals in drug testing[J]. Nat Biomed Eng, 2024, 8(8):930-935.
[35] CARRATT S A, ZUCH DE ZAFRA C L, OZIOLOR E, et al. An industry perspective on the FDA Modernization Act 2.0/3.0: Potential next steps for sponsors to reduce animal use in drug development[J]. Toxicol Sci, 2025, 203(1):28-34.
[36] DAO T, SADRIEH N. A CDER perspective: Landscape of New Approach Methodologies (NAMs) submitted in drug development programs[J]. Regul Toxicol Pharmacol, 2026,165:106007.
[37] TUTTY M A, SIMONE T, PRINA-MELLO A. Development of a complex 3D in vitro alternative model to evaluate the safety of advanced materials[J]. Toxicol Appl Pharmacol, 2025,504:117520.
[38] STUCKI A O, BARTON-MACLAREN T S, BHULLER Y, et al. Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of industrial chemicals and pesticides for effects on human health[J]. Front Toxicol, 2022,4:964553.
[39] REYES D R, ESCH M B, EWART L, et al. From animal testing to in vitro systems: Advancing standardization in microphysiological systems[J]. Lab Chip, 2024, 24(5):1076-1087.
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