华见微®肿瘤MRD定制化检测
循环肿瘤DNA（ctDNA）越来越多地被用于肿瘤微小残留病灶（minimal residual disease, MRD）的检测。由于在灵敏性和特异性等方面远远优于传统影像学和血清标志物检测，ctDNA被广泛地运用于药物临床试验和临床实践中[1-4]。
Signatera MRD test是由美国Natera公司开发的定制化MRD检测专利产品，在2019-2021年先后获得了3项美国FDA breakthrough device[5]及欧盟CE认证[6]，并被纳入美国商业医保，全面覆盖II期和III期结肠癌患者的MRD监测[7]。
2019年，华大基因独家引进Signatera MRD，检测技术，作为大中华区 (Greater China)唯一提供Signatera MRD检测的机构[8]。 结合华大基因自主测序平台，华见微
截止到2020年9月，应用Signatera技术的药企合作项目超过50项，覆盖15个癌种；目前已发表7项重要临床成果，覆盖结肠癌、乳腺癌、肺癌、膀胱癌、食管癌及泛癌免疫治疗，均刊登在国际顶尖杂志上[1-7]；2020年共发表25篇重大国际学术会议摘要，包括肿瘤学界最大的学术年会ASCO和ESMO。
Signatera技术在II期和III期结肠癌临床试验（IMPROVE-IT）中表现的优异临床性能[1]，直接推动了ctDNA检测进入NCCN结肠癌指南（2021.V2版）。指南中指明术后ctDNA是I-III期结肠癌复发风险升高的标志物，推荐在可切除结肠癌辅助化疗和复发监测中增加ctDNA检测，提供疗效预测和预后等信息，辅助医生进行决策。
检测流程
产品特点
临床应用场景
参考文献：
[1]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
[2]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
[3]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
[4]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
[5]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/
[6]https://www.natera.com/press-releases/nateras-signatera%E2%84%A2-test-receives-ce-mark
[7]https://www.natera.com/press-releases/natera-receives-final-medicare-coverage-its-signatera%E2%84%A2-mrd-test-stage-ii-iii
[8]https://www.natera.com/press-releases/natera-and-bgi-genomics-announce-50m-partnership-commercialize-signatera-oncology
[9]https://mp.weixin.qq.com/s/9SbuT2lJml4TMQmCtwOEqg
[10]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
[11]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.
[12]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
[13]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