可检出低频体细胞突变范围为0.01-0.1%,
最低检测限 (LoD) 达万分之一;
相比传统影像学和血清学等检测方法,
大幅提早发现肿瘤复发(如下图)
临床试验数据表明,
采用Signatera技术进行术后MRD监测,
可以有效评估手术效果,预测肿瘤复发,
组织+配对血测序,
可以抓取每个患者携带的特有变异,
有效过滤克隆性造血和胚系突变;
为每个患者量身定制高深度测序panel,精准追踪
Post-surgery only or post-surgery and adjuvant therapy
Post-surgery and adjuvant therapy
Post-surgery
适用于泛癌种,
目前已发表大量临床证据支持的癌种有:
结肠癌,乳腺癌,非小细胞肺癌等;
在研癌种共15个
首次检测:全外显子(WES)测序:肿瘤组织(新鲜手术组织/穿刺组织/FFPE肿瘤组织石蜡切片[保存时间一年以内])+ 全血(对照血)
监测节点:全血
华见微®-仅含定制化panel成功通知:
15个自然日[1]
华见微®-用药指导报告:
7个自然日[2]
华见微®-ctDNA监测(含监测报告):
14个自然日[3]
Reinert T, Henriksen TV, Christensen E, et al. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer [published online ahead of print, 2019 May 9] [published correction appears in JAMA Oncol. 2019 Jun 13;:]. JAMA Oncol. 2019;5(8):1124-1131. doi:10.1001/jamaoncol.2019.0528
Coombes RC, Page K, Salari R, et al. Personalized Detection of Circulating Tumor DNA Antedates Breast Cancer Metastatic Recurrence. Clin Cancer Res. 2019;25(14):4255-4263. doi:10.1158/1078-0432.CCR-18-3663
Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution [published correction appears in Nature. 2017 Dec 20;:]. Nature. 2017;545(7655):446-451. doi:10.1038/nature22364
Christensen E, Birkenkamp-Demtröder K, Sethi H, et al. Early Detection of Metastatic Relapse and Monitoring of Therapeutic Efficacy by Ultra-Deep Sequencing of Plasma Cell-Free DNA in Patients With Urothelial Bladder Carcinoma. J Clin Oncol. 2019;37(18):1547-1557. doi:10.1200/JCO.18.02052
https://www.natera.com/press-releases/fda-grants-breakthrough-device-designation-nateras-signatera-test; https://www.natera.com/company/news/fda-grants-two-new-breakthrough-device-designations-for-nateras-signatera-mrd-test/
https://www.natera.com/press-releases/nateras-signatera%E2%84%A2-test-receives-ce-mark
https://www.natera.com/press-releases/natera-receives-final-medicare-coverage-its-signatera%E2%84%A2-mrd-test-stage-ii-iii
https://www.natera.com/press-releases/natera-and-bgi-genomics-announce-50m-partnership-commercialize-signatera-oncology
https://mp.weixin.qq.com/s/9SbuT2lJml4TMQmCtwOEqg
Bratman, SV., Yang, SYC., Iafolla, MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer 1, 873–881 (2020). https://doi.org/10.1038/s43018-020-0096-5
Magbanua MJM, Swigart LB, Wu H-T, et al. Circulating tumor DNA in neoadjuvant treated breast cancer reflects response and survival. Annuals of Oncology. 2021 32(2):229-239.
Einstein DJ, Liang N, Malhotra M, et al. Assessment of Molecular Remission in Oligometastatic Esophageal Cancer With a Personalized Circulating Tumor DNA Assay. JCO Precision Oncology (2020). https://doi. org/10.1200/PO.19.00339
Powels T, Assaf, ZJ, Davarpanah N, Hussain M, et al., Clinical outcomes in post-operative ctDNA(+) muscle-invasive urothelial carcinoma patients after atezolizumab adjuvant therapy. ESMO Immuno-Oncology Congress 2020.12.09-12