Onconetix, Inc. (ONCO), Monday announced that new clinical data from a study of its prostate cancer diagnostic test, Proclarix, was presented at the 2025 European Association of Urology or EAU congress, demonstrating the strong clinical performance of Proclarix in a Danish cohort.
In this study, Proclarix was evaluated in 808 patients with suspected prostate cancer, including a challenging subpopulation of 371 patients with enlarged prostates.
The results showed that Proclarix significantly reduced the number of unnecessary biopsies by identifying patients with a low probability of clinically significant cancer.
In this subpopulation, Proclarix achieved a 5 percent or less probability of clinically significant cancer, outperforming other diagnostic tools such as %fPSA and the ERSPC risk calculator.
The clinical performance of Proclarix was further validated in a larger group of 654 patients, achieving a sensitivity of 96 percent and significantly higher specificity compared to %fPSA and the ERSPC risk calculator.
Proclarix is an in vitro diagnostic test that combines biomarker detection with a proprietary algorithm to assess a patient's risk of clinically significant prostate cancer.
It is CE-certified under the In Vitro Diagnostic Regulation or IVDR and is included in both European and American guidelines for prostate cancer diagnosis.
Onconetix plans to market Proclarix as a lab-developed test or LDT in the U.S. through a license agreement with Labcorp.
Currently, ONCO is trading at $0.12 down by 3.42 percent on the Nasdaq.
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