Department of Product Development, MDxHealth BV, Nijmegen, The Netherlands.
Department of Computational Biology, Statistics and AI, VOF dobbio, Zelzate, Belgium.
Prostate Cancer Prostatic Dis. 2022 Sep;25(3):583-589. doi: 10.1038/s41391-022-00562-1. Epub 2022 Jul 9.
Molecular biomarker tests are developed as diagnostic tools for prostate cancer (PCa) diagnosis. The SelectMDx (MDxHealth, Nijmegen, The Netherlands) test is a urinary-based biomarker test intended to be used to predict presence of high-grade PCa upon biopsy in men with elevated serum prostate-specific antigen (PSA) levels. Previous validation of the SelectMDx test revealed that 53% of the unnecessary biopsies (biopsies indicating no- or GG1 PCa) could be avoided using the SelectMDx test as a decision-tool to select men for prostate biopsy. The objective of this study is to examine the use of the commercially available SelectMDx test under routine, real-life practice.
Men that underwent a SelectMDx test between May 2019 and December 2020 and that were originating from countries that perform the SelectMDx test on a regular basis were included in this study, resulting in 5157 cases from 10 European countries. Clinical parameters, urinary RNA scores, and test outcomes were compared between PSA groups, age groups, countries, and the validation cohort (described previously [4]) using the Mann-Whitney U test, Chi-Square test, Benjamini-Hochberg and Kruskal-Wallis tests.
40.72% of the cases received a negative SelectMDx result. The test is also used in patients outside the intended-use population (PSA < 3 and >10 ng/mL). Clinical parameters (age, PSA density, DRE outcome) varied between patient population from individual countries and the validation cohort, resulting in differences in the potential number of saved biopsies using the test.
The potential number of reduced biopsies in clinical use was 40,72% using the SelectMDx test, assuming a negative SelectMDx test resulted in the decision not to biopsy the patient. This is higher compared to the validation cohort, which is explained by differences in patient population.
分子生物标志物检测被开发为前列腺癌 (PCa) 诊断的诊断工具。SelectMDx（MDxHealth，荷兰奈梅亨）检测是一种基于尿液的生物标志物检测方法，旨在用于预测血清前列腺特异性抗原 (PSA) 水平升高的男性活检中存在高级别 PCa。之前对 SelectMDx 检测的验证表明，53%的不必要活检（活检显示无或 GG1 PCa）可以通过 SelectMDx 检测作为决策工具来选择进行前列腺活检的男性来避免。本研究的目的是在常规实际情况下检查市售 SelectMDx 检测的使用情况。
本研究纳入了 2019 年 5 月至 2020 年 12 月期间进行 SelectMDx 检测且来自常规开展 SelectMDx 检测的国家的男性，共纳入了来自 10 个欧洲国家的 5157 例病例。使用 Mann-Whitney U 检验、卡方检验、Benjamini-Hochberg 和 Kruskal-Wallis 检验比较了 PSA 组、年龄组、国家和验证队列（先前描述 [4]）之间的临床参数、尿液 RNA 评分和检测结果。
40.72%的病例检测结果为阴性。该检测也用于预期用途人群（PSA<3 和 >10ng/mL）之外的患者。来自不同国家和验证队列的患者人群的临床参数（年龄、PSA 密度、DRE 结果）存在差异，导致使用该检测的潜在活检减少数量存在差异。
假设阴性 SelectMDx 检测结果导致决定不进行活检，则在临床使用中，使用 SelectMDx 检测可减少 40.72%的活检。这一比例高于验证队列，这是由于患者人群的差异所致。
