Onconetix’s Proclarix® Cuts Unnecessary Biopsies in 371-Patient Study; U.S. Trial Begins
Onconetix’s Proteomedix AG released two peer-reviewed studies showing Proclarix® significantly reduces overdiagnosis and unnecessary biopsies versus %fPSA and ERSPC risk calculator in a 371-patient cohort and predicts treatment transition in surveillance patients. A 500-patient U.S. PRIME validation study with Labcorp began enrollment and ~100 tests were carried out in U.K.
1. Clinical Publications
Proteomedix AG published two peer-reviewed clinical papers in Q1 2026. The first evaluated Proclarix® in a 371-patient Danish cohort, demonstrating superior accuracy in ruling out insignificant prostate cancer and reducing unnecessary biopsies compared with %fPSA and the ERSPC risk calculator. The second involved 132 men under surveillance and highlighted Proclarix®’s prognostic risk score in predicting transition to active treatment.
2. U.S. PRIME Study Initiation
Proteomedix AG has launched the PRIME study, a multi-center U.S. validation trial in collaboration with Labcorp. Initial enrollment is underway, aiming to recruit up to 500 men across diverse ethnic groups to confirm Proclarix® performance beyond Europe.
3. European Commercial Expansion
In Q1 2026, Proteomedix offered Proclarix® through a U.K. patient organization for real-world screening, completing approximately 100 tests. The company also secured a collaboration partner in Turkey and is advancing discussions in additional European markets.
4. Commercial Outlook and Impact
Proclarix® holds CE-IVD certification in the EU under IVDR and is slated for U.S. launch as a Labcorp lab-developed test. Successful validation and expanding market access could drive adoption, reduce costly biopsies, and support Onconetix’s revenue growth trajectory.