Review of Sentinel Assay for Prostate Cancer Diagnosis
Laurence Klotz, MD, FRCSC, Professor of Surgery at the University of Toronto and the Sunnybrook Chair of Prostate Cancer Research, reviews the Sentinel Assay, a urine-based assay for detecting prostate cancer currently awaiting FDA approval. He notes that there are several significant needs in the pre-biopsy setting, including the need to increase the probability of a positive biopsy, and the need to reduce overdetection and the number of unnecessary biopsies. Dr. Klotz observes that there are several commercially-available biomarker assays that seek to help with this, all of which appear to work fairly well, although perhaps not quite as well as miR Scientific’s Sentinel Assay appears to. He explains that the Sentinel Assay is based on analysis of 442 urinary exosome microRNA sequences, and that it can identify small high-grade tumors that may be missed by imaging or biopsy. Dr. Klotz then summarizes the results of the one paper published on the Sentinel Assay so far, observing that its findings that the Sentinel prostate cancer test demonstrates a sensitivity of 94% and specificity of 92% are almost too good to be true. He presents as-yet-unpublished data that supports these findings, showing a 93% concordance between the Sentinel Assay and pathology. Dr. Klotz concludes that while validation is still needed, the Sentinel Assay appears to be an extremely accurate urine-based assay that will be easy to ship and use.
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