NEW YORK, Sept. 14, 2020 /PRNewswire/ -- miR Scientific, LLC announced today that its disease management platform for prostate cancer has been selected as the winner in Questex's 2020 Fierce Innovation Awards — Life Sciences Edition in the Medical Device Innovation category. The Fierce Innovation Awards, a peer-reviewed awards program from the publisher of FierceBiotech and FiercePharma, has recognized miR Scientific for the miR Sentinel™ Prostate Test platform as an industry leading medical device innovation.
"Receiving the medical innovation award during National Prostate Cancer Awareness Month from such an extraordinarily accomplished peer-review panel of one of the industry's leading publishing groups further invigorates our team's fierce resolve to transform cancer management," said Sam Salman, Co-Founder and Chairman & CEO at miR Scientific. "Our innovation is a revolutionary validatedi platform that provides a molecular measure of malignancy of the entire organ with unmatched accuracy, and since it is entirely based on a single non-invasive urine specimen, broad accessibility and complete ease of use can be achieved."
The miR Sentinel™ Prostate Test solves a persistent global real-world problem involving the management of prostate cancer, a screened disease that represents the highest number of new cancer cases diagnosed annually and is the second leading cause of cancer deaths among men worldwide. The current standard of care (SOC) for screening prostate cancer fails to provide subjects and their providers with a definitive indication of the presence of disease and its severity. As a result, significantly less than half of the age-eligible male population in the US, and even less globally, interact with screening, potentially missing an early detection opportunity that may have likely allowed for successful disease management. The SOC too-often identifies healthy patients as being suspicious of disease, requiring them to be subjected to highly invasive, morbidities-prone and costly core needle biopsies. Significantly less than half-the men with a suspicion of disease are diagnosed with cancer. The SOC therefore suffers from high false positives, deadly false negatives and systematic health inequity across racial populations.
The miR Sentinel™ Prostate Test is an integrated platform that, from a single urine specimen, definitively classifies and monitors the risk of a subject into one of four groups: "No Molecular Evidence of Prostate Cancer" (NMEPC), or, for patients with molecular evidence of prostate cancer, Low Risk, Intermediate Risk, or High-Risk cancer. Validation data for the miR Sentinel™ Prostate Test were published in the September issue of The Journal of Urology. These data show that miR Scientific's platform can detect molecular evidence of prostate cancer with sensitivity of 94% and specificity of 92%, which translates to AUC of 0.98. When the cancer is diagnosed, the test further classifies the cancer as either low risk with sensitivity of 93% and specificity of 90%, which translates to AUC of 0.98, or critically, as high risk with sensitivity of 94% and specificity of 96%, which translates to AUC of 0.99. The Company is preparing for the large-scale commercial launch of the miR Sentinel™ Prostate Test as a CLIA and CLEP Lab Developed Test.
The Fierce Innovation Awards highlight companies that demonstrate innovative solutions, technologies and services that have the potential to make the greatest impact for biotech and pharma industries. Winners' and finalists' applications were reviewed by an exclusive panel of executives from major biotech and pharma companies. All applications were evaluated based on effectiveness, technical innovation, competitive advantage, financial impact and true innovation.
About the miR Scientific Sentinel Prostate Assay miR Scientific's published paper in the Journal of Urology makes reference to three separately validated tests: the miR Sentinel™ PCa Test, which determines whether or not there is molecular evidence of prostate cancer; the miR Sentinel™ CS Test, which for those with a positive miR Sentinel™ PCa Test (or other confirmatory cancer diagnosis), determines whether the cancer is low risk versus intermediate or high risk, and the miR Sentinel™ HG Test, which for those with a positive miR Sentinel™ PCa Test (or other confirmatory cancer diagnosis), identifies patients with high-grade, high-risk cancer. Directly based on the validation of three tests in the referenced large Journal of Urology cohort, miR Scientific generated the miR Sentinel™ Prostate Test as a single test that integrates the four possible outcomes based on a single urine specimen. The extraordinary sensitivity and specificity of the Sentinel tests enable them to be used non-invasively to screen, diagnose, prognose and monitor patients with prostate cancer without any other adjunctive test or analytic input such as a specific PSA, DRE or other value.
About miR Scientific miR Scientific, LLC is a healthcare company whose purpose is to transform cancer management by providing early and highly accurate detection, characterization and monitoring of disease. Our team developed the miR Scientific Disease Management Platform™, which is comprised of proprietary, non-invasive and highly accurate liquid biopsy urine tests for the detection, classification and monitoring of urological cancers. miR Scientific is a majority-owned operating subsidiary of Impact NRS LLC, headquartered in New York with operating subsidiaries in Israel, Canada and Puerto Rico.
i Wang et al, "Expression of Small Noncoding RNAs in Urinary Exosomes Classifies Prostate Cancer into Indolent and Aggressive Disease," THE JOURNAL OF UROLOGY®, Vol. 204 (September 2020): 466-475. https://doi.org/10.1097/JU.0000000000001020