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首页> 外文期刊>BMC Genomics >Analytical validation of the Onco type DX prostate cancer assay – a clinical RT-PCR assay optimized for prostate needle biopsies
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Analytical validation of the Onco type DX prostate cancer assay – a clinical RT-PCR assay optimized for prostate needle biopsies

机译：Onco DX型前列腺癌测定的分析验证–一种针对前列腺穿刺活检优化的临床RT-PCR测定

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Background The Onco type DX? Prostate Cancer Assay is a multi-gene RT-PCR expression assay that was developed for use with fixed paraffin-embedded (FPE) diagnostic prostate needle biopsies containing as little as 1 mm of prostate tumor in the greatest dimension. The assay measures expression of 12 cancer-related genes representing four biological pathways and 5 reference genes which are algorithmically combined to calculate the Genomic Prostate Score (GPS). This biopsy-based assay has been analytically and subsequently clinically validated as a predictor of aggressive prostate cancer. The aim of this study was to validate the analytical performance of the Onco type DX Prostate Cancer Assay using predefined acceptance criteria. Results The lowest quartile of RNA yields from prostate needle biopsies (six 5 μm sections) was between 19 and 34 ng. Analytical validation of the process requiring as little as 5 ng of RNA met all pre-defined acceptance criteria. Amplification efficiencies, analytical sensitivity, and accuracy of gene assays were measured by serially diluting an RNA sample and analyzing features of the linear regression between RNA expression measured by the crossing point (Cp) versus the log2 of the RNA input per PCR assay well. Gene assays were shown to accurately measure expression over a wide range of inputs (from as low as 0.005 ng to 320 ng). Analytical accuracy was excellent with average biases at qPCR inputs representative of patient samples Conclusions The Onco type DX Prostate Cancer Assay, a clinical RT-PCR assay specifically designed for use with prostate needle biopsies, has been analytically validated using very limited RNA inputs. The assay requirements and analytical performance will provide physicians with test results from a robust and reliable assay which will enable improved treatment decisions for men diagnosed with early-stage prostate cancer.
机译：背景Onco型DX？前列腺癌检测是一种多基因RT-PCR表达检测，开发用于固定石蜡包埋（FPE）诊断性前列腺穿刺活检，最大活检中仅需1 mm。该测定法测量了代表四种生物学途径的12种癌症相关基因和5种参考基因的表达，这些基因在算法上进行了组合以计算基因组前列腺评分（GPS）。这种基于活检的分析已被分析，随后在临床上被确认为侵袭性前列腺癌的预测因子。这项研究的目的是使用预定义的验收标准来验证Onco型DX前列腺癌检测的分析性能。结果前列腺穿刺活检（六个5μm切片）的最低RNA产量四分位数在19到34 ng之间。仅需5 ng RNA的过程分析验证就符合所有预定的接受标准。通过连续稀释RNA样品并分析交叉点（Cp）测得的RNA表达与log 2 之间的线性回归特征来测量扩增效率，分析灵敏度和基因测定的准确性。每个PCR测定孔的RNA输入量。结果表明，基因检测可准确测量各种输入（从低至0.005 ng至320 ng）的表达。结论代表患者样品的qPCR输入的平均偏倚具有极好的分析准确性结论结论Onco型DX前列腺癌检测是一种专为前列腺穿刺活检而设计的临床RT-PCR检测，已通过非常有限的RNA输入进行了分析验证。该检测要求和分析性能将为医生提供可靠而可靠的检测结果，从而为诊断为早期前列腺癌的男性提供更好的治疗决策。

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