Core Viewpoint - Onconetix, Inc. has presented new clinical data for its prostate cancer diagnostic test Proclarix® at the 2025 European Association of Urology congress, demonstrating its strong clinical performance in early detection of prostate cancer [1][3]. Company Overview - Onconetix, Inc. is a commercial stage biotechnology company focused on innovative solutions for men's health and oncology, having acquired Proteomedix and its Proclarix® test, which is CE-certified and expected to be marketed in the U.S. as a lab developed test [6]. Product Details - Proclarix® is designed to improve prostate cancer diagnosis by reducing unnecessary biopsies and over-detection of clinically insignificant cancer, addressing the limitations of the traditional PSA test [2][5]. - The test combines in-vitro assays for biomarker detection with a proprietary algorithm to assess the risk of clinically significant prostate cancer, and has been included in both European and American guidelines [5]. Clinical Study Findings - In a study involving 808 patients, Proclarix® showed a negative test result correlating to a 5% or less probability of clinically significant cancer in patients with elevated PSA levels, outperforming other diagnostic tools [3]. - The test demonstrated a sensitivity of 96% and significantly higher specificity compared to %fPSA and the ERSPC risk calculator in a larger cohort of 654 patients [3]. Expert Commentary - The primary investigator of the study emphasized that Proclarix® can safely reduce unnecessary biopsies by ruling out patients with clinically insignificant cancer while minimizing the risk of missing significant cases [4].
Onconetix Announces Successful Clinical Validation of its Innovative Prostate Cancer Test Proclarix in a Danish cohort