mir Sentinel™

An FDA Designated Breakthrough Device owned by MiRNA Scientific, Inc. that detects the presence of prostate cancer and accurately assesses the cancer’s aggressiveness using a simple non-invasive urine sample. The mir Sentinel Test has demonstrated a 97% sensitivity for patients with pathobiological evidence of prostate cancer. The traditional PSA test, MRI, and biopsy combination has just a 44% sensitivity level; making it highly inaccurate, invasive, and potentially leading to impotence, incontinence, infection, and over-treatment.

Outsmarting Cancer with Data

The mir Sentinel Test is a standalone, liquid biopsy urine test that detects and assess the risk of prostate cancer at the molecular level accurately and non-invasively. A proprietary machine learning algorithm determines the presence and aggression level of cancer anywhere in the prostate via a molecular analysis (invasive biopsies can only provide partial analysis of the gland).

A peer-reviewed validation study of the test was published in The Journal of Urology in 20201, followed by clinical study results presented at the 2022 American Urological Association conference. The Sentinel Test demonstrated a 97% sensitivity for the identification of patients with pathological evidence of prostate cancer. The current standard for detecting prostate cancer, PSA test plus MRI and biopsy, has just a 44% sensitivity level – making it highly inaccurate, invasive, and potentially leading to impotence, incontinence, infection, and over-treatment.2



ONE IN EIGHT MEN WILL BE DIAGNOSED WITH PROSTATE CANCER IN THEIR LIFETIME, WITH 1.4 MILLION NEW CASES DIAGNOSED GLOBALLY EACH YEAR.

Significant Cost Savings

The Sentinel Test costs significantly less than other diagnostic methods. The test costs approximately $1,500 USD in high volume usage by the healthcare industry. In comparison, PSA plus biopsy costs exceed $1,740 USD(without complications). A multiparametric MRI scan of the prostate costs $2,550 USD. 

Reducing biopsies

Broad adoption of the Sentinel Test could reduce the number of unnecessary biopsies by 40%, thereby reducing associated complications by up to 80%. Time and resources previously spent assessing and reassessing the aggressiveness of a patient’s prostate cancer can now be redirected to provide more effective care for other patients, particularly those requiring immediate intervention.This higher quality of care can reduce the economic burden currently associated with the ineffective, inaccurate, invasive, and unnecessary biopsies currently used to triage patients, and demonstrates the potential to revolutionize the global standards of care supporting urologic oncology.

1. Wang WLW, SorokinI, Aleksic I, et al. Expression of Small NoncodingRNAs in Urinary Exosomes Classifies Prostate Cancer into Indolent and Aggressive Disease.J Urol. 2020;204(3):466-475. doi:10.1097/JU.0000000000001020
2. BMJ 2009;339:b3537doi:10.1136/bmj.b3537

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