NEW YORK—Dr. Derya Tilki, attending urologist at the Martini-Klinik Prostate Cancer Center of the University Hospital Hamburg-Eppendorf, presented new data on miR Scientific’s Sentinel tests for detecting and classifying prostate cancer at the 2020 ASCO Genitourinary Cancers Symposium in San Francisco in February.
The precision bioscience company miR Scientific, which focuses on comprehensive disease detection and management, offers three non-invasive urine-based tests that are said to provide specificity and sensitivity of greater than 90 percent in detecting and classifying prostate cancer.
The recently completed case-control validation study included 1,436 patients, which consisted of 836 patients in a fully cross-validated training group and an independent testing group of 600 patients. The presentation was titled “Analysis of small non-coding RNAs in urinary exosomes to classify prostate cancer into low-grade (GG1) and higher-grade (GG2-5).”
The study involves the three tests in miR Scientific Sentinel Disease Management Platform for Prostate Cancer: the Sentinel PCa Test, which determines the presence or absence of prostate cancer; the Sentinel CS Test, which identifies patients with low-grade (GG1) or intermediate and high-grade (GG2-GG5) prostate cancer; and the Sentinel HG Test, which identifies patients with high-grade, high-risk cancer. Each of the tests examines the expression levels of small non-coding RNAs (sncRNAs) extracted from urinary exosomes to diagnose, classify and monitor prostate cancer. Classification algorithms identify and interrogate between 200 and 280 small non-coding RNAs using a customized, high-throughput qPCR OpenArray platform.
Validation study results demonstrate that the Sentinel PCa Test has a sensitivity of 94 percent and a specificity of 92 percent; the Sentinel CS Test has a sensitivity of 93 percent and a specificity of 90 percent; and the Sentinel HG Test has a sensitivity of 94 percent and a specificity of 96 percent. Company officials believe that the performance characteristics of these tests support miR Scientific's efforts to introduce the miR Scientific Disease Management Platform to mitigate poor outcomes and waste for patients, healthcare providers, employers and payers. The combination of the three tests, which are standalone, can be performed on a single urine sample for diagnosing, classifying and monitoring prostate cancer.
According to the company, the Sentinel Disease Management Platform gives patients and healthcare providers an unprecedented level of information, potentially allowing for more accurate, precise and effective treatment of urological cancers. The results presented at ASCO GU suggest that the Sentinel platform is significantly more accurate than current testing methods in detecting prostate cancer and offers highly specific and sensitive data on the severity and aggressiveness of the cancer.
“The results presented at ASCO GU demonstrate that the miR Scientific Sentinel Tests can transform clinical practice with broadly new and powerful capabilities to directly classify patients into actionable pathways: those with no evidence of prostate cancer; patients in need of definitive treatment; and patients eligible for active surveillance, which the Sentinel Tests can monitor,” said Sam Salman, chairman and CEO of miR Scientific. “The accuracy demonstrated by the miR Scientific Sentinel tests is significantly better than that of other current technologies and could prove to be even more accurate, as we are currently ascertaining what proportion of this discordance represents misattribution of core needle biopsy histopathology or genuine misclassification errors of the Sentinel Tests.”
He added, “miR Scientific believes that the results suggest that the non-invasive Sentinel tests can be used as part of the Sentinel Prostate Cancer Disease Management Platform to provide patients and healthcare providers with an unprecedented level of information, allowing for more accurate and effective treatment of these cancers.”
According to Dr. James M. McKiernan, the John K. Lattimer Professor and chairman of the Department of Urology at Columbia University College of Physicians and Surgeons, “The burden of over-diagnosis and unnecessary treatments in prostate cancer worldwide is well known. What has been lacking is an effective, non-invasive tool to identify which patients may harbor aggressive cancers that are life-threatening. The miR Scientific platform of liquid biopsy represents a highly sensitive and accurate way to identify these patients, with less need for invasive procedures.”