miR Scientific, has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its miR Sentinel PCC4 Assay, also called miR Sentinel Prostate Test.
The US-based healthcare company miR Scientific, an operating subsidiary of Impact NRS, engaged in transforming cancer management by offering accurate and early detection, characterisation and monitoring of disease.
The company said that its new miR Sentinel Prostate Test offers a new method to analyse small non-coding RNAs (sncRNA) derived from a simple, non-invasive urine specimen from age-eligible men.
A company’s statistical classification algorithm that uses only expression level of the sncRNAs will derive scores to classify patients according to the likelihood of being into four possible groups that include no molecular evidence of prostate cancer group, low-risk group, intermediate-risk group, or high-risk prostate cancer group.
miR Scientific to market the test in the US
The company intends to initially market the test in the US, as a laboratory developed test.
The specificity, sensitivity and empirical NPV and PPV of the miR Sentinel Prostate Test is expected to reduce mortality and decrease the hospitalisation, physician visits and recovery time for patients, compared to the currently available technologies.
Furthermore, also developed miR Scientific Disease Management Platform, which comprises unique non-invasive and precise liquid biopsy urine tests for the detection, classification and monitoring of urological cancers.
The company intends to use the platform to commercialise the advanced miR Sentinel Prostate Test.
miR Scientific chairman and CEO Sam Salman said: “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.
“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.”
