Zurich-Schlieren, Switzerland, April 25, 2023. Proteomedix, a Swiss diagnostics company committed to advance prostate cancer care, today announced that Proclarix® has been included in the 2023 European Association of Urology (EAU) Guidelines for the diagnostic evaluation of prostate cancer.
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 (PI-RADS 3 lesions).
Dr. Ralph Schiess, Chief Scientific officer and co-founder of Proteomedix commented: “The inclusion of Proclarix in the EAU guidelines is a significant recognition of the clinical value of Proclarix. It serves as a validation for the clinical utility and importance of using Proclarix in the non-invasive detection of prostate cancer.”
The EAU guidelines assist clinicians in making informed treatment decisions, taking into account the available scientific data. The inclusion of Proclarix in the EAU guidelines is an important milestone and will enable broader acceptance of the test and contribute to drive payor adoption.
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.
Proteomedix is a healthcare company whose mission is to transform prostate cancer diagnosis. The company has identified novel biomarker signatures with utility in prostate cancer diagnosis, prognosis and therapy management. The lead product Proclarix® is a blood based prostate cancer test panel and risk score currently available in Europe. Proteomedix is located in the Bio-Technopark of Zurich-Schlieren, Switzerland. For more information, visit www.proteomedix.com.
For further details, please contact:
Dr. Ralph Schiess, CSO
firstname.lastname@example.org, +41 44 733 40 90