Evaluation of the MiCheck MIA test performance in differentiating aggressive from non-aggressive prostate cancer: The MiCheck-01 prospective trial.

TPS152Background: A diagnostic test which can better inform both clinicians and patients regarding a decision to proceed with a prostate biopsy, while still utilizing traditional parameters of Prostate Specific Antigen (PSA) kinetics and/or the digital rectal examination (DRE) is still an unmet need. The MiCheck® test is designed as a triage test to assist clinicians in the decision to proceed to prostate biopsy. The MiCheck®test is a simple blood test that measures the levels of the Glypican-1 protein and related signalling molecules. The MiCheck®-01 prospective trial builds on a previous pilot trial that examined the ability of the MiCheck® test to distinguish between normal subjects, patients with benign disease or Gleason 7 and above prostate cancer. The MiCheck® test showed sensitivity of 60% and specificity of 96% in distinguishing between subjects with Gleason ≥7 and normal or BPH patients. In a separate study, the MiCheck® test could differentiate aggressive (GS ≥3+4) from non-aggressive (GS 3+3) ...