Proclarix, developed by the Swiss start-up Proteomedix, has been included in the 2023 European Association of Urology (EAU) Guidelines for the diagnostic evaluation of prostate cancer as well as in the 2023 clinical practice guideline for the early detection of prostate cancer of the American Urology Association. The inclusion of Proclarix in the guidelines is an important milestone for Proclarix and will enable broader acceptance of the test and contribute to drive payor adoption.
Screening for prostate cancer still is one of the most controversial topics in the urological literature. The current standard method for prostate cancer screening combines a digital rectal exam (DRE) with the measurement of prostate-specific antigen (PSA). However, PSA is not a highly cancer specific marker leading to overdiagnosis. In fact more than half of all men that undergo a biopsy, have no clinically significant prostate cancer but are at risk to suffer from potential side effects such as infections or bleeding and the psychological burden of a cancer diagnosis.
To reduce the number of negative biopsies in asymptomatic men with a PSA level between 3–10 ng/mL and a normal DRE, the EAU guidelines recommend using an online risk-calculator that is correctly calibrated to the population prevalence, magnetic resonance imaging (MRI) of the prostate or an additional biomarker test such as Proclarix. It is specifically stated that Proclarix has been correlated with the detection of significant prostate cancer, notably in case of equivocal MRI. The EAU guidelines assist clinicians in making informed treatment decisions, taking into account the available scientific data.
Shortly after the inclusion in the European Association of Urology (EAU) guideline, Proclarix was also included in the 2023 clinical practice guideline of the AUA/SUO (American Urology Association / Society of Urologic Oncology). The guideline covers recommendations on the early detection of prostate cancer and provides a framework to facilitate clinical decision-making in the implementation of prostate cancer screening, biopsy, and follow-up.
Proclarix is CE-certified under IVDR and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer.
(Press release / SK)
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