miR Scientific has announced the commercial launch of its miR Sentinel Prostate Cancer Test in the US, Puerto Rico and some international markets.
A urine-based molecular test, miR Sentinel leverages a biostatistical algorithm to evaluate small non-coding RNA.
Designed to help in the clinical management of men over 45 years old, the test can evaluate the risk of aggressive prostate cancer.
In a study group involving around 1,100 male participants, the miR Sentinel Test was found to have detected molecular proof of prostate cancer in at-risk men with a 98.5% sensitivity. It also showed an 83% prognostic sensitivity in differentiating clinically non-significant from clinically significant prostate cancers.
The results of this recent clinical study, which was carried out at several locations within the US and Puerto Rico, were presented at the 2022 American Urological Association’s Annual Meeting.
miR Scientific chairman and CEO Sam Salman said: “We believe that the miR Sentinel Test offers patients and providers a non-invasive means of accurately assessing a man’s prostate cancer risk, which could potentially reduce unnecessary biopsies and biopsy-related complications in men with low risk of clinically significant prostate cancer while prioritising diagnostic and treatment resources to those men that potentially harbour clinically significant prostate cancer.
“This aligns with miR Scientific’s vision to revolutionise prostate cancer disease management by improving accessibility and accuracy of the tools used to assess each man’s personal risk of aggressive disease.”
The present version of the miR Sentinel Test is a clinically validated assessment developed for commercialisation based on the company’s miR Sentinel PCC4 assay.
This assay secured Breakthrough Device Designation from the US Food and Drug Administration (FDA) in Q3 2020.