miR Scientific LLC, Rensselaer, New York.
Division of Urology, Department of Surgery, Albany Medical College, New York.
J Urol. 2020 Sep;204(3):466-475. doi: 10.1097/JU.0000000000001020. Epub 2020 Mar 19.
This is the first report of the development and performance of a platform that interrogates small noncoding RNAs (sncRNA) isolated from urinary exosomes. The Sentinel™ PCa Test classifies patients with prostate cancer from subjects with no evidence of prostate cancer, the miR Sentinel CS Test stratifies patients with prostate cancer between those with low risk prostate cancer (Grade Group 1) from those with intermediate and high risk disease (Grade Group 2-5), and the miR Sentinel HG Test stratifies patients with prostate cancer between those with low and favorable intermediate risk prostate cancer (Grade Group 1 or 2) and those with high risk (Grade Group 3-5) disease.
sncRNAs were extracted from urinary exosomes of 235 participants and interrogated on miR 4.0 microarrays. Using proprietary selection and classification algorithms, informative sncRNAs were selected to customize an interrogation OpenArray™ platform that forms the basis of the tests. The tests were validated using a case-control sample of 1,436 subjects.
The performance of the miR Sentinel PCa Test demonstrated a sensitivity of 94% and specificity of 92%. The Sentinel CS Test demonstrated a sensitivity of 93% and specificity of 90% for prediction of the presence of Grade Group 2 or greater cancer, and the Sentinel HG Test demonstrated a sensitivity of 94% and specificity of 96% for the prediction of the presence of Grade Group 3 or greater cancer.
The Sentinel PCa, CS and HG Tests demonstrated high levels of sensitivity and specificity, highlighting the utility of interrogation of urinary exosomal sncRNAs for noninvasively diagnosing and classifying prostate cancer with high precision.
这是首次报道开发和评估一种平台的结果，该平台可检测从小分子非编码 RNA（sncRNA）中分离的尿液外泌体。Sentinel™ PCa 检测可将前列腺癌患者与无前列腺癌证据的患者区分开来，miR Sentinel CS 检测可将前列腺癌患者分为低危前列腺癌（G 分组 1）和中高危疾病（G 分组 2-5），miR Sentinel HG 检测可将前列腺癌患者分为低危和中危（G 分组 1 或 2）与高危（G 分组 3-5）疾病。
从 235 名参与者的尿液外泌体中提取 sncRNA，并在 miR 4.0 微阵列上进行检测。使用专有的选择和分类算法，选择有信息 sncRNA 来定制一个询问 OpenArrayTM 平台，这是检测的基础。使用 1436 名患者的病例对照样本对这些检测进行了验证。
miR Sentinel PCa 检测的性能显示出 94%的敏感性和 92%的特异性。Sentinel CS 检测对预测存在 G 分组 2 或更高分级癌症的敏感性为 93%，特异性为 90%，而 Sentinel HG 检测对预测存在 G 分组 3 或更高分级癌症的敏感性为 94%，特异性为 96%。
Sentinel PCa、CS 和 HG 检测显示出了高水平的敏感性和特异性，强调了非侵入性地检测和分类前列腺癌的尿液外泌体 sncRNA 的询问的实用性，具有高精度。
