Onconetix Announces Successful Clinical Validation of its Innovative Prostate Cancer Test Proclarix in a Danish cohort
Onconetix (NASDAQ: ONCO) has announced successful clinical validation results for its prostate cancer test Proclarix® in a Danish cohort, presented at the 2025 European Association of Urology congress. The study, involving 808 patients with suspected prostate cancer, demonstrated Proclarix's superior performance compared to traditional diagnostic methods.
In a subgroup of 371 patients with enlarged prostates, Proclarix® showed significantly better results than existing tools, with only 5% probability of missing clinically significant cancer, compared to 14% for %fPSA and 20% for the ERSPC risk calculator. The test reduced unnecessary biopsies by 22% while missing only 3 out of 101 significant cancers.
In the broader study group of 654 patients with PSA levels of 2-20 ng/ml, Proclarix® achieved 96% sensitivity and significantly higher specificity compared to current diagnostic tools.
Onconetix (NASDAQ: ONCO) ha annunciato risultati di validazione clinica di successo per il suo test sul cancro alla prostata Proclarix® in una coorte danese, presentati al congresso della European Association of Urology del 2025. Lo studio, che ha coinvolto 808 pazienti con sospetta diagnosi di cancro alla prostata, ha dimostrato la superiorità delle prestazioni di Proclarix rispetto ai metodi diagnostici tradizionali.
In un sottogruppo di 371 pazienti con prostata ingrossata, Proclarix® ha mostrato risultati significativamente migliori rispetto agli strumenti esistenti, con solo il 5% di probabilità di perdere un cancro clinicamente significativo, rispetto al 14% per %fPSA e al 20% per il calcolatore di rischio ERSPC. Il test ha ridotto le biopsie non necessarie del 22%, mancando solo 3 su 101 cancri significativi.
Nel gruppo di studio più ampio di 654 pazienti con livelli di PSA tra 2-20 ng/ml, Proclarix® ha raggiunto una sensibilità del 96% e una specificità significativamente più alta rispetto agli strumenti diagnostici attuali.
Onconetix (NASDAQ: ONCO) ha anunciado resultados de validación clínica exitosos para su prueba de cáncer de próstata Proclarix® en una cohorte danesa, presentados en el congreso de la European Association of Urology de 2025. El estudio, que involucró a 808 pacientes con sospecha de cáncer de próstata, demostró el rendimiento superior de Proclarix en comparación con los métodos de diagnóstico tradicionales.
En un subgrupo de 371 pacientes con próstata agrandada, Proclarix® mostró resultados significativamente mejores que las herramientas existentes, con solo un 5% de probabilidad de perder un cáncer clínicamente significativo, en comparación con el 14% para %fPSA y el 20% para el calculador de riesgo ERSPC. La prueba redujo las biopsias innecesarias en un 22%, mientras que solo falló en 3 de 101 cánceres significativos.
En el grupo de estudio más amplio de 654 pacientes con niveles de PSA de 2-20 ng/ml, Proclarix® logró una sensibilidad del 96% y una especificidad significativamente más alta en comparación con las herramientas de diagnóstico actuales.
온코네틱스 (NASDAQ: ONCO)는 2025년 유럽 비뇨기과 협회 congress에서 발표된 덴마크 코호트에서 전립선암 검사 프로클라릭스®의 성공적인 임상 검증 결과를 발표했습니다. 이 연구는 전립선암이 의심되는 808명의 환자를 대상으로 하였으며, 프로클라릭스의 성능이 전통적인 진단 방법에 비해 우수함을 입증했습니다.
비대해진 전립선을 가진 371명의 환자 하위 그룹에서 프로클라릭스®는 기존 도구들보다 유의미하게 더 나은 결과를 보여주었으며, 임상적으로 중요한 암을 놓칠 확률이 5%에 불과했습니다. 반면, %fPSA는 14%, ERSPC 위험 계산기는 20%였습니다. 이 검사는 불필요한 생검을 22% 줄였으며, 101개의 중요한 암 중 3개만 놓쳤습니다.
PSA 수치가 2-20 ng/ml인 654명의 환자로 구성된 더 넓은 연구 그룹에서는 프로클라릭스®가 96%의 민감도와 현재의 진단 도구에 비해 유의미하게 높은 특이도를 달성했습니다.
Onconetix (NASDAQ: ONCO) a annoncé des résultats de validation clinique réussis pour son test de cancer de la prostate Proclarix® dans une cohorte danoise, présentés lors du congrès de l'European Association of Urology en 2025. L'étude, impliquant 808 patients suspectés d'avoir un cancer de la prostate, a démontré la performance supérieure de Proclarix par rapport aux méthodes de diagnostic traditionnelles.
Dans un sous-groupe de 371 patients ayant une prostate agrandie, Proclarix® a montré des résultats significativement meilleurs que les outils existants, avec seulement 5% de probabilité de manquer un cancer cliniquement significatif, contre 14% pour %fPSA et 20% pour le calculateur de risque ERSPC. Le test a réduit les biopsies inutiles de 22%, tout en manquant seulement 3 cancers significatifs sur 101.
Dans le groupe d'étude plus large de 654 patients avec des niveaux de PSA de 2 à 20 ng/ml, Proclarix® a atteint une sensibilité de 96% et une spécificité significativement plus élevée par rapport aux outils de diagnostic actuels.
Onconetix (NASDAQ: ONCO) hat erfolgreiche klinische Validierungsergebnisse für seinen Prostatakrebs-Test Proclarix® in einer dänischen Kohorte bekannt gegeben, die auf dem Kongress der European Association of Urology 2025 präsentiert wurden. Die Studie, an der 808 Patienten mit Verdacht auf Prostatakrebs teilnahmen, zeigte die überlegene Leistung von Proclarix im Vergleich zu herkömmlichen Diagnosetools.
In einer Untergruppe von 371 Patienten mit vergrößerten Prostatadrüsen zeigte Proclarix® signifikant bessere Ergebnisse als die bestehenden Werkzeuge, mit nur 5% Wahrscheinlichkeit, klinisch signifikanten Krebs zu übersehen, im Vergleich zu 14% für %fPSA und 20% für den ERSPC-Risikorechner. Der Test reduzierte unnötige Biopsien um 22%, während nur 3 von 101 signifikanten Krebserkrankungen übersehen wurden.
In der breiteren Studiengruppe von 654 Patienten mit PSA-Werten von 2-20 ng/ml erreichte Proclarix® eine Sensitivität von 96% und eine signifikant höhere Spezifität im Vergleich zu den aktuellen Diagnosetools.
- Clinical validation showed 96% sensitivity in detecting prostate cancer
- 22% reduction in unnecessary biopsies
- Superior performance vs existing diagnostic tools (5% vs 14-20% miss rate)
- Missed only 3 out of 101 significant cancer cases
- 5% probability of missing clinically significant cancer still exists
- to patients with PSA levels of 2-20 ng/ml
Insights
The clinical validation of Proclarix represents a significant advancement in prostate cancer diagnostics with compelling performance metrics that address a critical clinical need. The results from this 808-patient Danish cohort demonstrate Proclarix's superior ability to reduce unnecessary biopsies while maintaining high detection rates for clinically significant cancers.
Three key performance indicators stand out: First, in patients with enlarged prostates (a challenging diagnostic subgroup), Proclarix delivered only a
For Onconetix, this validation strengthens their market position in the prostate diagnostics space, which faces growing demand for more accurate, non-invasive testing solutions. The current standard PSA testing suffers from well-documented specificity issues, creating a substantial market opportunity. Presentation of these results at the prestigious EAU congress provides credibility and visibility that could accelerate clinical adoption, potentially driving near-term revenue growth as urologists seek better tools to reduce unnecessary procedures.
CINCINNATI, March 24, 2025 (GLOBE NEWSWIRE) -- Onconetix, Inc., (Nasdaq: ONCO) ("Onconetix" or the “Company”), (formerly Blue Water Biotech, Inc. (BWV)), a cancer diagnostics company focused on the research, development and commercialization of innovative solutions for oncology, today announced that new clinical data of Proclarix® was presented on March 23, 2025 during the 2025 European Association of Urology (EAU) congress, which data further demonstrates the strong clinical performance of Proclarix® in a Danish cohort.
The primary approach for early detection of prostate cancer is through testing serum levels of prostate-specific antigen (PSA). However, given the limited cancer specificity of PSA, Proclarix® is addressing the urgent need for improved diagnosis by lowering the burden of potential over-detection of clinically insignificant prostate cancer resulting in unnecessary biopsies.
In the study presented, Proclarix® was evaluated in prospectively collected samples from 808 patients with suspected prostate cancer. In the challenging subpopulation including 371 patients with an enlarged prostate and thus frequently presenting elevated PSA levels leading to false-positive results, a negative Proclarix test resulted in a probability of
Primary investigator and presenter of the study, Ahmed H. Zedan, MD, PhD from Lillebaelt Hospital - University Hospital of Southern Denmark said: ”Proclarix can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer and by minimizing the risk of missing clinically significant cancer”.
About Proclarix®
Proclarix® is CE-certified under In Vitro Diagnostic Regulation (“IVDR”) and indicated for prostate cancer diagnosis in patients with normal digital rectal exam (DRE), enlarged prostate volume and elevated levels of PSA at 2-10 ng/ml. Proclarix® is a risk score combining in-vitro assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient’s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix® risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix® is included in both the European (EAU) and American (AUA) guidelines.
About Onconetix, Inc.
Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the IVDR, which we anticipate will be marketed in the U.S. as a lab developed test (“LDT”) through our license agreement with Labcorp. We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated results of the Company’s sales and marketing efforts for its commercial stage products as described herein) are based on Onconetix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions; risks related to Onconetix’s ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with Proteomedix; risks related to the Company’s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix’s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company’s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix’s products; risks related to the Company’s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq’s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company’s securities; and the Company’s reliance on third parties, including manufacturers and logistics companies. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of biotechnology products. Onconetix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Onconetix’s Annual Report on Form 10-K, filed with the SEC on April 11, 2024 and periodic reports filed with the SEC on or after the date thereof. All of Onconetix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor and Media Contact Information:
Onconetix, Inc.
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Phone: (513) 620-4101
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FAQ
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