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FDA grants breakthrough designation to urine-based liquid biopsy for prostate cancer


The miR Sentinel PCC4 Assay is a non-invasive test that has achieved sensitivity and specificity rates above 90% for both detecting and classifying prostate tumors.

The FDA has granted a breakthrough device designation to the miR Sentinel PCC4 Assay (miR Sentinel Prostate Test), a urine-based, non-invasive test that can be used to diagnose, classify, and monitor prostate cancer.1

Initial data validating the efficacy of the assay were previously published in the Journal of Urology.2 The findings showed sensitivity and specificity rates of greater than 90% for both detecting prostate tumors and classifying them as intermediate or high risk.

The breakthrough designation will expedite the development and regulatory review of the miR Sentinel PCC4 assay.

"We are highly appreciative that the FDA's breakthrough designation process provided miR Scientific with invaluable feedback, which we have incorporated into our current clinical prospective studies to support our full marketing authorization plan," Sam Salman, chairman and CEO of miR Scientific, stated in a press release.1

"Receiving this designation achieves another important milestone in the development of our novel and ground-breaking technology. We believe that the accuracy and non-invasive feature of our award-winning technology will impact the lives of millions of men and forever positively change the standard of care for urological cancers," added Salman.

The miR Sentinel PCC4 Assay involves interrogating small noncoding RNAs (sncRNAs) that have been extracted from urinary exosomes. The interrogation of the sncRNAs is done through a high-throughput real-time PCR–based platform. Proprietary selection and classification algorithms are used to analyze the interrogated sncRNAs.

In the study, the investigators extracted sncRNAs from urinary exosomes of the 235 enrolled individuals. The sncRNAs were interrogated on miR 4.0 microarrays. According to the researchers, “Using proprietary selection and classification algorithms, informative sncRNAs were selected to customize an interrogation OpenArray platform that forms the basis of the tests.”2 Validation of the tests was done using a case-control sample that consisted of 1436 individuals.

The Sentinel Prostate Test showed a sensitivity rate of 94% and a specificity rate of 92% in detecting prostate cancer. The sensitivity and specificity rates were 93% and 90%, respectively, for the prediction of Grade Group ≥2 cancer, and, the corresponding rates were 94% and 96%, respectively, for the prediction of Grade Group ≥3 cancer.

In an accompanying editorial simultaneously published in the Journal of Urology,3 Brian Helfand, MD, division of urology, NorthShore University HealthSystem, Evanston, Illinois, discussed the significance of the findings.

“Urologists are all too familiar with the inherent limitations of prostate cancer screening. As such, novel biomarker tests that can better distinguish both prostate cancer from indolent disease and high-grade from indolent tumors are greatly needed,” wrote Helfand.


1. miR Scientific announces FDA Breakthrough Device Designation for its Prostate Cancer Liquid Biopsy Test. Published October 13, 2020. https://prn.to/3ky6Tqi. Accessed October 13, 2020.

2. Wang W-L, Sorokin I, Aleksic I, et al. Expression of small noncoding RNAs in urinary exosomes classifies prostate cancer into indolent and aggressive disease. J Urol. 2020 Sep;204(3):466-475. Doi: 10.1097/JU.0000000000001020

3. Helfand B. Editorial Comment. J Urol. 2020 Sep;204(3):474-475. doi: 10.1097/JU.0000000000001020.01

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