Side by side evaluation of Proclarix® and the Prostate Health Index (phi) for the identification of clinically significant prostate cancer

Zurich-Schlieren, Switzerland, August 23, 2022. Proteomedix, a Swiss diagnostics company committed to advance prostate cancer care, today announced the publication of new results comparing its own product Proclarix^® and the Prostate Health Index (phi) test from Beckman Coulter.

Early detection of prostate cancer is widely performed using screening of total prostate‐specific antigen (PSA) and percentage of its free fraction (%fPSA). However, this setting is associated with a significant overdiagnosis of benign and indolent disease resulting in a high number of men undergoing unnecessary biopsy of the prostate.

The phi test from Beckman Coulter and, more recently, Proclarix have been proposed as serum biomarkers more specific for prostate cancer and thus reducing the burden of overdiagnosis. A recent study led by Prof. Daniela Terracciano from the University of Naples “Federico II” in Italy and Prof. Thomas Steuber from the Martini‐Klinik at University Hospital Hamburg‐Eppendorf in Germany evaluated Proclarix and phi for predicting clinically significant prostate cancer in a total of 344 men. The results were recently published in The Prostate and can be accessed through this link.

Prof. Steuber commented: “Both Proclarix and phi accurately predicted clinically significant cancer. When using predefined cut‐offs recommended by the manufacturers, Proclarix (cut‐off 10) outperformed phi (cut‐off 27) in terms of specificity and positive predictive value (p < 0.002) at similar sensitivities.” Prof. Terracciano added: “Combining the Proclarix‐score and phi showed the highest clinical net benefit. The combination would have avoided 56% of unneeded biopsies while accurately diagnosing clinically significant prostate cancer with 91% sensitivity.”