New noninvasive urine test shows high precision in prostate cancer detection and classification

A urine-based, noninvasive assay demonstrated high rates of sensitivity and specificity in diagnosing and classifying patients with prostate cancer, according to findings published in the Journal of Urology.^1,2

The Sentinel Prostate Test (miR Scientific) is a platform of individual assays for both prostate cancer screening and determining the risk level of the disease. The study results demonstrated that each of the assays achieved sensitivity and specificity rates above 90%.

James McKiernan, MD

“The miR Scientific Sentinel Test validation data in the Journal of Urology significantly contributes to the state-of-the-art innovation capabilities available to physicians. The scientists, researchers and biostatisticians involved in the creation of this breakthrough platform paid very close attention to the needs of physicians whose work always focuses on intervening at the earliest possible opportunity to provide life-saving care for patients harboring aggressive disease, and improving outcomes and quality of life for patients with indolent disease. I am proud to be among a leading cohort of physicians who will support the integration of the miR Scientific tests into clinical standards and practice," James McKiernan, MD, the John K. Lattimer Professor of Urology, and the chair of the Department of Urology of the College of Physicians and Surgeons and urologist-in-chief at NewYork-Presbyterian/Columbia, stated in a press release.

The Sentinel Test platform involves interrogating small noncoding RNAs (sncRNAs) that have been extracted from urinary exosomes. The interrogation of the sncRNAs is done through a high-throughput real-time PCR–based platform. Proprietary selection and classification algorithms are used to analyze the interrogated sncRNAs.

The three individual assays incorporated into the Sentinel Test platform are the Sentinel PCa Test, the Sentinel CS Test, and the Sentinel HG Test. The Sentinel PCa Test is the prostate cancer diagnostic assay. The Sentinel CS Test determines which patients have low-risk disease (Grade Group 1) and which patients have intermediate- or high-risk prostate cancer (Grade Group 2-5). The Sentinel HG Test identifies which patients have either low or favorable intermediate risk disease (Grade Group 1 or 2) and which patients have high-risk disease (Grade Group 3-5).

In the study, the investigators extracted sncRNAs from urinary exosomes of the 235 enrolled individuals. The sncRNAs were interrogated on miR 4.0 microarrays. According to the researchers, “Using proprietary selection and classification algorithms, informative sncRNAs were selected to customize an interrogation OpenArray platform that forms the basis of the tests.” Validation of the tests was done using a case-control sample that consisted of 1436 individuals.

The Sentinel PCa Test showed a sensitivity rate of 94% and a specificity rate of 92%. The sensitivity and specificity rates were 93% and 90%, respectively, for the prediction of Grade Group ≥2 cancer with the Sentinel CS Test, and the corresponding rates were 94% and 96% with the Sentinel HG Test for the prediction of Grade Group ≥3 cancer.

In an accompanying editorial also published in the Journal of Urology,³ Brian Helfand, MD, division of urology, NorthShore University HealthSystem, Evanston, Illinois, discussed the significance of the findings and noted that further validation might still be needed before standard integration of this new technology into clinical practice.

Brian Helfand, MD

“Urologists are all too familiar with the inherent limitations of prostate cancer screening. As such, novel biomarker tests that can better distinguish both prostate cancer from indolent disease and high-grade from indolent tumors are greatly needed,” wrote Helfand. “Overall, the results appear to be promising new prostate cancer biomarkers for each of these tests. However, some caution should be made with any novel test including the requirement to validate the results in other independent cohorts and racially diverse groups.”

References

1. Wang W-L, Sorokin I, Aleksic I, et al. Expression of small noncoding RNAs in urinary exosomes classifies prostate cancer into indolent and aggressive disease. J Urol. 2020 Sep;204(3):466-475. Doi: 10.1097/JU.0000000000001020

2. miR Scientific Announces Validation of its Urine Based, Non-Invasive Prostate Cancer Test Published in the Journal of Urology. Published August 10, 2020. https://bit.ly/2CiG88t. Accessed August 11, 2020.

3. Helfand B. Editorial Comment. J Urol. 2020 Sep;204(3):474-475. doi: 10.1097/JU.0000000000001020.01