August 23, 2022

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.”

About Proclarix®

Proclarix® is CE-IVD marked 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.

About Proteomedix

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

schiess@proteomedix.com, +41 44 733 40 9