Biomarker Reference Lab

项目摘要(BRL) 纽约大学BCC EDRN的最终目标是开发临床实验室改进修正案(CLIA) 能够识别早期肺癌并预测复发风险的分级分析 手术后早期疾病的切除。我们已经有很有希望的数据表明这是可以实现的 通过对微生物和宿主基因组签名的评估。这些将在Biomarker上进行进一步的研究 发展实验室(BDL)，采用不可知组学方法，确定最佳表现 预测性功能。生物标记物参考实验室(BRL)的目标是开发标准化、 经过分析验证的生物标记物分析，将针对由 BDL.为了做到这一点，我们将有与所用的相匹配的血浆、黄大衣和下呼吸道样本 在BDL中发现作为参考样本，用于在BRL中对我们的定制面板进行“第一次”临床验证。 在目标1中，我们将开发一个有针对性的微生物基因组下一代测序(NGS)小组，用于血液和 下呼吸道标本可预测早期非小细胞肺癌的诊断和预后。DNA探针将被设计成 以BDL中确定的分类群为目标。在目标2中，我们将评估靶向代谢物小组是否使用LC- 血和下呼吸道标本的MS检测可预测早期非小细胞肺癌的诊断和预后。在……里面 目标3，我们将测试定制的NanoString面板，以检测来自Buffy Coats和Low Airways的RNA最佳靶向 执行BDL中确定的功能。选定的队列将在发现和验证中进行划分。 成功的生物标记物随后将接受外部验证。拟议的工作将在我们的CLIA进行 经批准的实验室基础设施。这里开发的管道将提供一种新的方法，可以 为EDRN联盟中的其他人确定的多个目标定制。虽然每种方法都清楚地表明 观察微生物DNA、代谢物或宿主RNA靶标签名，一致使用来自 确定的受试组将使我们能够估计组合不同类型测量的生物标记物的作用 同时通过不同的方法进行诊断和预后预测。然后这些调查就可以 导致开发一种新的多方法生物标记物，该标记物将识别更多高风险对象 激进的干预可能是有必要的。

Project summary (BRL) The ultimate goal of the NYU BCC EDRN is to develop Clinical Laboratory Improvement Amendments (CLIA) grade assays that will allow for identification of early stage lung cancer and will predict the risk of recurrence post-surgical removal of early stage disease. We already have promising data that this can be accomplished through evaluation of microbial and host genomic signatures. These will be further investigated in the Biomarker Developmental Laboratory (BDL) with agnostic omics approaches leading to identification of best performing predictive features. The goal of the Biomarker Reference Laboratory (BRL) is to develop standardized, analytically validated-biomarker assays that will target promising microbial and host signatures identified by the BDL. In order to do so, we will have matching plasmas, buffy coats, and lower airway samples to the ones used in the BDL for discovery as reference samples for “first order” clinical validation of our custom panels in the BRL. In Aim 1, we will develop a targeted microbial genomic next generation sequencing (NGS) panel for blood and lower airway samples predictive of diagnosis and prognosis of early-stage NSCLC. DNA probes will be designed targeting taxa identified in the BDL. In Aim 2, we will evaluate whether a targeted metabolite panel using an LC- MS approach in blood and lower airway samples can predict diagnosis and prognosis of early-stage NSCLC. In Aim 3, we will test a custom-made NanoString panel for RNA from buffy coats and lower airways targeting best performing features identified in the BDL. The cohort selected will be divided in Discovery and Validation. Successful biomarkers will then undergo external validation. The proposed work will be performed in our CLIA approved laboratory infrastructure. The pipelines developed here will provide a novel approach that can be customized to multiple targets identified by others in the EDRN consortium. While each approach is distinctly looking at microbial DNA, metabolites or host RNA target signatures, the consistent use of samples from a defined group of subjects will allow us to estimate the role of combining different types of biomarkers measured in parallel through different approaches for diagnostic and prognostic prediction. These investigations can then lead to the development of a new multi-approach biomarker that will identify high risk subjects where more aggressive interventions might be warranted.