Urine Liquid Biopsy Test Detects Molecular Evidence of Prostate Cancer

By LabMedica International staff writers
Posted on 29 Mar 2022

Image: Sentinel can detect prostate cancer from a single urine specimen (Photo courtesy of miR Scientific)

A standalone, non-invasive liquid biopsy urine test can, from a single urine specimen, accurately detect molecular evidence of prostate cancer and, if cancer is detected, classify the severity, or the risk grade, of the malignancy.

The miR Sentinel Prostate Cancer Test from miR Scientific, LLC (New York, NY, USA) uses proprietary high-throughput technology based on the interrogation of small noncoding RNAs (sncRNAs) extracted from urinary exosomes. The highly accurate, easy-to-administer miR Sentinel Prostate Cancer Test is powered by the miR Disease Management Platform, the company’s proprietary, non-invasive algorithm-based platform for the effective management of targeted diseases, initially focused on urological cancers. The platform uses precise biologic information interrogation techniques to categorize patients into one of four groups: no cancer, low-risk cancer, intermediate-risk cancer, or high-risk cancer. This gives physicians the ability to clearly determine which patients need treatment and which can be safely and non-invasively monitored, helping avoid harmful and costly overtreatment.

One urine sample is all that’s required for the test to accurately diagnose and classify prostate cancer with 95% sensitivity and specificity, thereby avoiding the standard invasive and inaccurate screening procedures. The test was shown in clinical studies to detect and classify clinically significant prostate cancer with over 90% accuracy. Based on these results, the U.S. Food & Drug Administration has granted the test a Breakthrough Device Designation. When comparing the results of the miR Sentinel Prostate Cancer Test to systematic core needle biopsy in men presenting with initial suspicion of prostate cancer, the latest validation study demonstrated a 93% concordance between the two methods of screening and detection regarding the classification of clinically significant cancer.

"We believe that the accuracy, accessibility, and non-invasive features of our award-winning technology will impact the lives of millions of men and forever positively evolve the standard of care for urological cancers," said Sam Salman, Chairman and CEO of miR Scientific.

Related Links:
miR Scientific, LLC