{"entity":{"id":"proclarix","kind":"drug","name":"Proclarix","aka":[],"tldr":"Proclarix is a blood test from Onconetix for men whose PSA result is unclear. It gives a risk score to help decide whether a prostate biopsy is needed.","summary":"Proclarix, developed by Proteomedix and owned by Onconetix, is CE-marked and approved for sale in the European Union under the In Vitro Diagnostic Regulation. It is intended for men with elevated PSA in the diagnostic grey zone, where deciding whether a biopsy is needed is difficult. Onconetix cites a published 371-man cohort in which Proclarix ruled out clinically insignificant or absent prostate cancer with a low risk of missing clinically significant cancer, and a 2026 study of 132 men under active surveillance. In the United Kingdom a patient organisation offers it within a screening initiative, with about 100 tests carried out by 31 March 2026. Onconetix expects US marketing as a laboratory-developed test through Labcorp.","status":"established","asOf":"2026-11-04","links":[{"label":"SEC: Onconetix Form S-1/A, August 2026","url":"https://www.sec.gov/Archives/edgar/data/1782107/000121390026095703/ea0303846-s1a1_onconetix.htm"}],"tags":["pipeline"],"related":["prolaris"],"cancers":[],"sections":[],"technologies":["prostate-screening-psa-mri"],"targets":[],"drugs":[],"companies":["onconetix"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo startup monitors","editedOn":"2026-11-04"},"modality":"Blood protein biomarker test (prostate cancer risk score)","mechanism":"A multiparametric protein blood test run on the same sample as a PSA test, which combines its markers into the Proclarix Risk Score to help decide whether a biopsy is needed in men with PSA in the diagnostic grey zone, as described by Onconetix.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/proclarix/","neighbours":{"drug":[{"id":"prolaris","kind":"drug","name":"Prolaris","route":"/drugs/prolaris/"}],"technology":[{"id":"prostate-screening-psa-mri","kind":"technology","name":"PSA and MRI-first prostate cancer screening","route":"/technologies/prostate-screening-psa-mri/"}],"company":[{"id":"onconetix","kind":"company","name":"Onconetix","route":"/companies/onconetix/"}]}}