TEST:

Sentinel Prostate Test™

P=N/A; Recruiting --> Active, not recruiting | N=4000 --> 2019 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Jun 2024

"miR Scientific, LLC announces the miR Sentinel™ Prostate Cancer Test is now commercially available in the United States, Puerto Rico and select international markets. miR Sentinel™ is a novel, urine-based, molecular test that analyzes small non-coding RNA using a proprietary biostatistical algorithm. The miR Sentinel™ Test assesses the risk of aggressive prostate cancer and is intended to aid in the clinical management of men >45 years of age at risk for prostate cancer." "

Sentinel Test cross-validation study versus Grade Group Conclusions : The miR Sentinel Test offers an accurate non-invasive means to accurately identify the presence or absence of prostate cancer and classify risk status predict pathological grade on biopsy. The high predictive accuracy of the test in patients whose systematic and targeted biopsy were discordant suggests that the 23% discordance between negative biopsy results and positive Sentinel Test results was in most cases due to false negative biopsies.

"miR Scientific...and Leonie Hill Capital...announced today the signing of a collaboration agreement to partner in the commercial launch of the award-winning miR Sentinel™ Prostate Cancer Test in Singapore and Southeast Asia."

The Sentinel test costs of $8.5m are offset by savings in MRI and biopsy ($5.4m) and biopsy related complications ($2.9m) costs. Conclusion Sentinel identifies and risk classifies PCa non-invasively, substantially reduces unnecessary biopsies, provides overall budget savings over a 3-year period, and resolves the uncertainty from suspicious PSA more effectively than Current Care.

"miR Scientific announced at the Puerto Rico Urologists Convention that it will open a registry of patients who wish to receive the new miR Sentinel™ Prostate Cancer Test, which the company expects will be commercially available by the end of the year."

P=N/A; N=2000 --> 4000 | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022

The miR Sentinel® PCC4 Test appears to offer an accurate non-invasive means to accurately identify the presence or absence of prostate cancer and predict pathological grade on biopsy.

P; N=500; Recruiting; Sponsor:miR Scientific LLC

The Sentinel™ PCa, CS and HG Tests, demonstrated high levels of sensitivity and specificity, highlighting the utility of interrogation of urinary exosomal sncRNAs for non-invasively diagnosing and classifying prostate cancer with high precision.