Novel urine-based liquid biopsy launched in US prostate cancer market

The miR Sentinel urine-based liquid biopsy for assessing the risk of aggressive prostate cancer has been made commercially available in the United States, according to miR Scientific, the developer of the assay.¹

Specifically, the miR Sentinel molecular test uses a biostatistical algorithm to examine small noncoding RNAs isolated from urinary exosomes and determine an individual’s risk of aggressive prostate cancer. According to the company, the test is intended to facilitate clinicians in the management of men aged 45 and above who are at risk for prostate cancer.

At the 2022 AUA Annual Meeting, researchers share a study showing evidence of the test’s efficacy. The research included about 1100 men at clinical sites in the United States and Puerto Rico. In at-risk men, the miR Sentinel test detected molecular evidence of prostate cancer with 98.5% sensitivity. Further, the test had an 83% prognostic sensitivity when distinguishing between clinically significant and non-significant prostate tumors.

The researchers also looked at a subset of men for whom MRI-guided and TRUS biopsies did not agree on whether the individual had prostate cancer. For this group, the miR Sentinel correctly identified 71 (99%) of 72 cases in which men had been found to have prostate cancer by either biopsy type. miR Scientific further noted in a news release that, “87% of men with PSA levels <3 found to have pathologic grade group 2 through 5 upon biopsy were identified by the miR Sentinel test as having molecular evidence of intermediate or high risk of aggressive disease.”

In the news release, Laurence Klotz, MD, FRCSC, CM, chief medical officer at miR Scientific, and professor of Surgery and Chair of Prostate Cancer Research at University of Toronto Sunnybrook, stated, “Accurate assessment of a man's individual risk related to prostate cancer is one of the cornerstones of appropriate patient management.The miR Sentinel test has the potential to provide a significant improvement over the current tools that are available to physicians. The implementation of such an innovation into practice could have a dramatic impact on outcomes through appropriately guiding the need for further diagnostic workup in men with elevated risk of significant cancer and guiding treatment in those subsequently diagnosed."

Reference

1. miR Scientific is proud to announce the commercial availability of the miR Sentinel™ Prostate Cancer Test. Published online July 13, 2022. Accessed July 19, 2022. https://prn.to/3zgPVGI