miR Scientific, LLC, a healthcare company whose purpose is to transform global cancer management by providing early and highly accurate detection, characterization and monitoring of disease, announced today that it has received Breakthrough Device Designation by the U.S Food & Drug Administration for its miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test). FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The Company’s miR Sentinel™ Prostate Test is a new method to analyze small non-coding RNAs (sncRNA) derived from a simple, non-invasive urine specimen from age-eligible men. Using only the expression level of these sncRNAs, a proprietary Statistical Classification Algorithm derives scores that classify patients according to the likelihood of being in the following four possible groups: no molecular evidence of prostate cancer; low-risk; intermediate-risk; or high-risk prostate cancer. Initial validation data for the miR Sentinel™ Prostate Test was published in the September 2020 issue of The Journal of Urology. The Company will initially commercialize its test as a Laboratory Developed Test in the US. Through the Breakthrough Device Program, miR Scientific will work more closely and frequently with the FDA to expedite its review of the miR Sentinel™ Prostate Test.
In comparison to currently available technologies alone, the specificity, sensitivity and empirical NPV and PPV of the miR Sentinel™ Prostate Test may significantly reduce mortality and decrease the number of hospitalizations, physician visits and reduce recovery time. The Company designed the miR Sentinel™ Prostate Test to revolutionize a patient’s disease journey when used by a provider in conjunction with other clinical findings and/or laboratory tests.
“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” said Sam Salman, Chairman and CEO of miR Scientific. “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”.
Source – PRNewswire