Onconetix Reports Q1 2026 Progress at Proteomedix AG, Including Two New Peer-Reviewed Publications and Initiation of U.S. Validation Study

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Onconetix Reports Q1 2026 Progress at Proteomedix AG, Including Two New Peer-Reviewed Publications and Initiation of U.S. Validation Study New Clinical Data Reinforce Proclarix® Performance in Reducing Overdiagnosis and Unnecessary Biopsies; Multi-Center PRIME Study Initiated in Collaboration with Labcorp; European Commercial Expansion Advances CINCINNATI, Ohio, May 13, 2026 (GLOBE NEWSWIRE) -- Onconetix, Inc. (Nasdaq: ONCO) (“Onconetix” or the “Company”) today provided an update on the Q1 2026 operational progress of its fully-owned Swiss subsidiary, Proteomedix AG (“PMX”), developer of Proclarix®, a CE-IVD certified diagnostic blood test used in combination with PSA (prostate-specific antigen) to identify clinically significant prostate cancer (“csPCa”). Prostate cancer is the most frequently diagnosed male cancer in most countries globally and represents a significant burden to patients and healthcare systems. Proclarix® is designed to support clinicians in distinguishing clinically significant from clinically insignificant prostate cancer at an early stage, reducing unnecessary biopsies and overdiagnosis. New Peer-Reviewed Clinical Publications Two new peer-reviewed scientific publications from a recent clinical study conducted in Denmark further reinforce the clinical utility of Proclarix®. The first paper, by Schiess et al., has been accepted for publication in BMC Cancer, a renowned open-access oncology research journal. The study evaluated Proclarix® in a cohort of 371 men and demonstrated its superior performance in ruling out clinically insignificant or absent prostate cancer while maintaining a low risk of missing csPCa. Proclarix® was shown to significantly reduce overdiagnosis and unnecessary biopsies, outperforming both %fPSA and the ERSPC risk calculator. The second paper, by Athanasiou et al., has been published in the journal Cancers (2026, 18, 1348–62). In a cohort of 132 men under active surveillance, the study demonstrated the prognostic value of Proclarix® and its risk score in predicting the transition of patients from active surveillance to active treatment. PRIME Study Initiated with Labcorp To evaluate Proclarix® in the U.S. market and across various ethnicities, PMX has initiated the PRIME study, a multi-center clinical validati...

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