Business UpdateMay 13, 2026, 09:27 AM
Onconetix Initiates PRIME Study with Labcorp for Proclarix® US Evaluation
AI Summary
Onconetix's subsidiary, Proteomedix AG, provided Q1 2026 operational updates for its Proclarix® diagnostic blood test. New peer-reviewed clinical data reinforced Proclarix®'s ability to reduce overdiagnosis and unnecessary biopsies for prostate cancer. The company initiated the multi-center PRIME study in collaboration with Labcorp to evaluate Proclarix® for the U.S. market, with up to 500 men to be enrolled. Additionally, European commercial expansion advanced, with nearly 100 tests performed in a UK screening initiative and a new partnership identified in Turkey.
Key Highlights
- Initiated PRIME study with Labcorp to evaluate Proclarix® for the U.S. market.
- PRIME study aims to enroll up to 500 men across various ethnicities.
- New clinical study in Denmark evaluated Proclarix® in a cohort of 371 men.
- Proclarix® demonstrated superior performance in reducing overdiagnosis and unnecessary biopsies.
- A separate study in 132 men showed prognostic value for predicting transition to active treatment.
- Nearly 100 Proclarix® tests were carried out in a UK screening initiative in Q1 2026.
- Identified a collaboration partner in Turkey for European market expansion.
Price Impact
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