
FoundationOne CDx | Foundation Medicine
FoundationOne®CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx) that is clinically and analytically validated for all solid tumors.
FoundationOne Liquid CDx - Foundation Medicine
What is FoundationOne®Liquid CDx? FoundationOne®Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw. It is the only FDA-approved blood-based test to analyze over 300 genes**—making it the most comprehensive FDA-approved liquid biopsy on the market.
FoundationOne CDx – P170019/S014 | FDA
2022年6月24日 · FoundationOne CDx is a laboratory test designed to find genetic variations in 324 genes, as well as some specific gene rearrangements and other biomarkers, including microsatellite instability...
FoundationOne-CDx™ 技术文档 - 简书
2017年11月30日 · F1CDx 是基于NGS的体外诊断试剂, 用于检测324个基因的SNV/INDEL,CNAs,部分基因的重排,MSI 和 TMB。 它作为一种伴随诊断产品可以检测表1中的突变,为病人的用药提供指导。 F1CDx 可用于FFPE样本和肿瘤新鲜组织的检测。 它可以检测324个基因,包括309个肿瘤相关基因的外显子区域,1个promoter区域,1个ncRNA,34个基因的内含子区域(用于检测基因重排),34个基因中的21个基因也涵盖检测外显子区域。 测序平台为 …
FDA批准F1CDx作为K药在MSI-H泛实体瘤中的伴随诊断 - 健康界
2022年2月26日 · F1CDx是DNA-based NGS的组织体外诊断产品,可检测324个基因的 SNVs,Indels,CNVs和 Rearrangements 四种变异类型及TMB(肿瘤突变负荷)、MSI(微卫星不稳定性)和HRD(同源重组缺陷:tBRCA阳性和/或LOH-H)三种基因组特征。 F1CDx也是目前唯一一个拿下三个泛实体瘤药物治疗生物标志物(NTRK1/2/3,TMB,MSI-H)的伴随诊断产品。 F1CDx如何检测MSI状态? 为了确定肿瘤患者的MSI状态,F1CDx采用基于分 …
CDx (F1CDx) is a qualitative ne xt-generation sequencing based . in vitro. diagnostic test that uses targeted high throughput hybridization-based capture technology for detection of...
不服不行!全球肿瘤基因检测行业标杆-Foundation Medicine - 知乎
2018年, FDA 批准了首个针对泛肿瘤的全面的伴随诊断检测FoundationOne CDx ,这个产品覆盖324个基因、两个可以预测免疫检查点抑制剂疗效的分子标记(MSI/TMB)、覆盖全部实体瘤、直接对应FDA批准的17个靶向治疗方案! 01FDA批准的首个也是唯一一个泛癌种的伴随诊断! 2017年11月,美国食品和药品管理局(FDA)批准Foundation Medicine公司的FoundationOne CDx (F1CDx)用于肿瘤临床诊断。 这款产品是目前FDA批准的唯一一个临床肿瘤用药的泛癌种 …
FoundationOne®CDx (F1CDx) is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number...
FoundationOne®CDx (F1CDx) is a qualitative next-generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations
FoundationOne® CDx (F1CDx) is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor
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