Onconetix Inc. (NASDAQ: ONCO) reported operational progress for its Proclarix prostate cancer diagnostic test during the first quarter of 2026, according to a company press release.

The company announced two new peer-reviewed publications supporting its Proclarix test, which is designed to identify clinically significant prostate cancer when used with PSA testing. The first study by Schiess et al., accepted for publication in BMC Cancer, evaluated 371 men and showed the test's performance in ruling out clinically insignificant prostate cancer while maintaining low risk of missing significant cases.

A second paper by Athanasiou et al., published in the journal Cancers, demonstrated the test's prognostic value in predicting when 132 men under active surveillance would transition to active treatment.

Onconetix initiated the PRIME study, a multi-center clinical validation study conducted with Labcorp Holdings Inc. to evaluate Proclarix in the U.S. market across various ethnicities. The study has enrolled its first participants and is designed to include up to 500 men.

The company expanded its European commercial presence during the quarter. In the United Kingdom, Proclarix is offered through a patient organization screening initiative, with close to 100 tests conducted in the first quarter. The company also identified a collaboration partner in Turkey.

Proclarix is a CE-IVD certified diagnostic blood test developed by Proteomedix AG, Onconetix's fully-owned Swiss subsidiary. The test is approved for sale in the European Union and is anticipated to be marketed in the U.S. as a lab-developed test through the Labcorp license agreement.