Supporting Providers

Help identify patients with the greatest need by adding the miR Sentinel™ Prostate Cancer Test to your detection and risk-classification toolbox.

• Granted FDA Designated Breakthrough Device^†
• One-step, non-DRE, first-void urine sample is all that is required.

97% Sensitivity for any prostate cancer

In the 432-patient independent test set, 97% (231/238) of patients with biopsy-confirmed prostate cancer were correctly identified by miR Sentinel as having Molecular Evidence of Prostate Cancer.¹

91% Sensitivity for clinically significant disease (Grade Group ≥2)

91% (126/139) of patients with biopsy-confirmed Grade Group ≥2 prostate cancer were identified by miR Sentinel as having Molecular Evidence of Elevated-Risk for Aggressive Prostate Cancer.¹

Identification of cases missed by one of two biopsy modalities.
‍In a dual-biopsy subset, 22 patients were diagnosed with Grade Group ≥2 prostate cancer by one biopsy method (TRUS-guided systematic or MRI-targeted) but with either no prostate cancer or Grade Group 1 disease by the other. miR Sentinel correctly identified 20 of those 22 patients (91%) as having Molecular Evidence of Elevated-Risk for Aggressive Prostate Cancer.¹

Among 7 patients in the same subset with Grade Group ≥3 disease confirmed by one biopsy modality but missed by the other, miR Sentinel correctly identified 7 of 7 (100%) as Elevated-Risk.¹

About miR Sentinel™

The miR Sentinel™ Prostate Cancer Test v2.0 is a Laboratory Developed Procedure (LDP) that utilizes a novel method to assess a patient’s risk of harboring aggressive prostate cancer; the test interrogates small noncoding RNAs (sncRNA) that are isolated from urinary exosomes. These sncRNAs are independent of other clinical markers such as prostate specific antigen (PSA). The results of the miR Sentinel™ Prostate Cancer Test submitted here classify patients into one of three categories: No molecular evidence of prostate cancer (NMEPC), Low Risk, and Elevated Risk. For a more complete explanation of the methodology, please visit: https://www.mirnascientific.com

DISCLAIMERS

This report does not constitute medical advice specifically directed at a patient concerning that patient's condition. Only a physician or other qualified healthcare professional may advise a patient on the use of information in this report. This test is not the only way to detect the presence of prostate cancer. The test is limited to determining the molecular signatures of small noncoding RNAs associated by the test for risk of aggressive prostate cancer. This test does not measure a patient's inherited risk for prostate cancer and does not provide information on the anatomy or focality of a tumor. These results cannot be interpreted as absolute evidence of the presence or absence of malignant disease and physicians should utilize this result only in conjunction with other standard of care information to determine whether to proceed with diagnostic workup (e.g. tissue biopsy), surveillance or treatment. The physiological effect of any given classification depends on the individual’s clinical profile. A number of factors are typically examined when considering a patient for prostate cancer workup including, but not limited to, age, medications, lifestyle, comorbidities etc. Impact of medications for Benign Prostatic Hyperplasia treatment, including 5α-reductase inhibitors, was not evaluated in the Training or Verification cohort and results should be interpreted with caution. It is important for the physician or qualified healthcare professional to interpret test results in the context of an individual's profile. It remains the responsibility of the healthcare provider to determine appropriate next steps for a patient. The patient's test results should not be disclosed to a third party unless related to the patient's treatment or payment for treatment, without the patient's express written authorization. The classification and interpretation of all sncRNAs identified in this test reflects the current state of scientific understanding at the time this report was issued and may change as new scientific information becomes available. This test has not been cleared or approved by the US Food and Drug Administration (the "FDA"). The FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. This test was developed, and its performance characteristics (summary available upon request) determined by MiRNA Scientific, Inc.