Dr. Laurence Klotz M.D., FRCSC, CM, the Chief Medical Officer of miR Scientific LLC, presents the results of the recently completed Case-Control validation study of 1,436 patients consisting of 836 patients in a fully cross-validated training group and independent testing group of 600 patients.
The study describes the miR Scientific Sentinel Disease Management Platform™ for Prostate Cancer which currently consists of three tests: The Sentinel PCa Test™, that 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™ that identifies patients with high grade, high-risk cancer. Each test examines the expression levels of small non-coding RNAs (sncRNAs) extracted from urinary exosomes to diagnose, classify and monitor prostate cancer. The company’s classification algorithms identify and interrogate between 200-280 small non-coding RNAs using a customized, high throughput qPCR OpenArray platform for each test.
The results of the validation study demonstrate that the Sentinel PCa Test™ has a sensitivity of 94% and a specificity of 92%; the Sentinel CS Test™ has a sensitivity of 93% and a specificity of 90%; and the Sentinel HG Test™ has a sensitivity of 94% and a specificity of 96%. The performance characteristics of these tests support the company’s efforts to introduce the miR Scientific Disease Management Platform™ to mitigate poor outcomes and waste for patients and all key stakeholders, including healthcare providers, employers and payors. This validation now enables stakeholders to engage as early adopters worldwide. The combination of the three tests, which are standalone, do not require nor rely on any other testing nor risk analysis and can be performed on a single urine sample, providing a very precise platform for disease management, with high utility for diagnosing, classifying and monitoring prostate 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 & 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. 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 health care providers with an unprecedented level of information, allowing for more accurate and effective treatment of these cancers.”
Renowned practitioners have expressed their confidence in these results. “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,” said James M. McKiernan, M.D., the John K. Lattimer Professor and Chairman of the Department of Urology at Columbia University College of Physicians and Surgeons, Urologist in Chief, New York Presbyterian Hospital.
Source – miR Scientific