GALEAS™ Bladder
膀胱癌基因檢測
GALEAS™ Bladder是由英國伯明翰大學的研究人員與 Nonacus 共同開發的膀胱癌篩檢測試。這項檢測利用次世代定序（NGS）技術，針對所有膀胱癌中常見的主要體細胞突變進行分析。基於 Nonacus 開發的超高靈敏度 NGS 技術，GALEAS™ Bladder 能夠高靈敏且精確地檢測尿液中 gDNA與腫瘤相關基因。
檢測能力
在從三個cohort study中收集的 770 份尿液樣本中，GALEAS™ Bladder 在所有膀胱癌的分期與分級中展示了高檢測靈敏度和特異性。
| Sensitivity | Specificity | NPV | |
|---|---|---|---|
| pTa | 86% | 86% | 93% |
| T1 | 95% | 86% | 99% |
| T2+ | 89% | 86% | 97% |
| G1 | 76% | 86% | 96% |
| G2 | 92% | 86% | 97% |
| G3 | 92% | 86% | 95% |
| NMIBC | 89% | 86% | 92% |
| MIBC | 89% | 86% | 97% |
GALEASTM Bladder
NMIBC
靈敏度: 89%
特異性: 86%
NPV 92: %
GALEASTM Bladder
MIBC
靈敏度 89%
特異性: 86%
NPV: 97%
膀胱鏡檢查 (1,2)
靈敏度: 84%
特異性: 86%
NPV: 96%
1.Chao-Zhe Zhu, et al., J Cancer. 2019, A review on the accuracy of bladder cancer detection methods.
2.Quentin Alimi, et al., Neurourol Urodyn. 2018. Reliability of urinary cytology and cystoscopy for the screening and diagnosis of bladder cancer in patients with neurogenic bladder: A systematic review.
3.Ward et al ; Eur Urol Oncol, 2023, Highly Sensitive and Specific Detection of Bladder Cancer via Targeted Ultra-deep Sequencing of Urinary DNA
4.Ward et al. BJU Int. 2019, Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification
GALEAS™ Bladder的使用時機：血尿
每年有數十萬名血尿患者被介紹到醫療機構進行膀胱鏡檢查，以確定是否存在癌症。然而，在這些病例中，最終被診斷出膀胱癌的患者僅約佔 10%。這意味著大量患者進行了不必要且具疼痛的侵入性程序，造成龐大的醫療成本。
GALEAS™ Bladder 提供了一種對血尿患者的非侵入性分子分流方案，能快速且精確地檢測膀胱癌，從而提升診斷效率。這項檢測已在超過 700 名患者的尿液樣本中得到驗證，在所有癌症分期與分級中展示了卓越的性能 (1, 2)。
檢測報告說明
- 陽性或陰性判定
- 檢測到的體細胞突變詳細資訊
GALEAS™ 雲端分析軟體
GALEAS™ 分析軟體能提供醫師陽性或陰性和變異位點資訊結果作為臨床診斷參考。
患者使用專用的採尿管進行尿液樣本收集
採尿管被送至分析實驗室進行基因定序。
將定序結果上傳至 GALEAS™ 分析軟體。
定序結果進行分析並生成報告。
醫生與患者說明檢測結果並討論下一步。
參考文獻
1. Zhu, C. Z., Ting, H. N., Ng, K. H., & Ong, T. A. (2019). A review on the accuracy of bladder cancer detection methods. Journal of cancer, 10(17), 4038. Full article
2. Alimi, Q., Hascoet, J., Manunta, A., Kammerer‐Jacquet, S. F., Verhoest, G., Brochard, C., … & Peyronnet, B. (2018). Reliability of urinary cytology and cystoscopy for the screening and diagnosis of bladder cancer in patients with neurogenic bladder: a systematic review. Neurourology and Urodynamics, 37(3), 916-925. Full article
3. Ward et al. BJU Int. 2019, Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification
3. Ward DG, Gordon NS, Boucher RH, et al. Targeted deep sequencing of urothelial bladder cancers and associated urinary DNA: a 23-gene panel with utility for non-invasive diagnosis and risk stratification. BJU Int. 2019;124(3):532-544. doi:10.1111/BJU.14808. Full article
