Overdosage, repeated biopsies and their complications make PSA an imperfect biomarker. An increased PSA may be caused by other factors other than cancer, such as infections, inflammation or benign prostatic hyperplasia (BPH).
The clinical utility of SelectMDx for Prostate Cancer is well-established:
• Men identified by the test as having a high likelihood of clinically significant cancer can, upon biopsy, be diagnosed and treated sooner.
• Men with low risk for prostate cancer can avoid biopsy and associated complications and continue to be monitored through urine tests.
• The test’s negative predictive value (NPV) is 98%, meaning if the test identifies a very low risk, the physician and patient can be 98% sure the patient does not have Gleason score ≥7 prostate cancer and avoid a biopsy.1
• The test has a very high predictive accuracy (AUC 0.87) for high-grade prostate cancer, which is significantly better than the Prostate Cancer Prevention Trial (PCPT) risk calculator version.1
• It is recognized as biomarker in prostate cancer diagnosis and it is mentioned in EAU 2018 guides3
1. Van Neste L, et al. (2016) Detection of High-grade Prostate Cancer Using a Urinary Molecular Biomarker-Based Risk Score. Eur Urol, Nov; 70(5): 740-748.
2. Govers TM, et al. (2018) Cost-Effectiveness of Urinary Biomarker Panel in Prostate Cancer Risk Assessment. J Urol. doi: 10.1016/j.juro.2018.07.034
3. Mottet N, et al. 2018 EAU Prostate Cancer Guidelines.