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 

ONCO

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

Onconetix Reports Key Developments for Proclarix Prostate Cancer Diagnostic

<section class="insight" data-version="1">
  <section data-block="information">
    <h3>Information</h3>
    <p>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</p>
  </section>

  <section data-block="ai-summary-paragraph">
    <h3>AI Summary</h3>
    <p>Onconetix has made significant strides with Proclarix, its prostate cancer diagnostic, while also launching the PRIME study in partnership with Labcorp to evaluate its efficacy in the U.S. The improved clinical data and strategic European expansion suggest a strong market potential, especially as Proclarix aims to reduce unnecessary procedures.</p>
  </section>

  <section data-block="ai-summary-bullets">
    <h3>Key Points</h3>
    <ul><li>Onconetix reports progress in Q1 2026 for Proclarix diagnostic tests.</li><li>Two new publications demonstrate Proclarix&#039;s effectiveness in reducing overdiagnosis.</li><li>PRIME study launched with Labcorp, enrolling 500 male participants in the U.S.</li><li>Proclarix expands commercial presence in Europe, including initiatives in the UK and Turkey.</li><li>Onconetix anticipates U.S. market entry through Labcorp&#039;s partnership.</li></ul>
  </section>

  <section data-block="companies-mentioned">
    <h3>Companies Mentioned</h3>
    <ul><li><strong>Labcorp (LH)</strong>: Partnering with Onconetix to conduct the PRIME study.</li></ul>
  </section>

  <section data-block="category">
    <h3>Corporate Developments</h3>
    <p>This article falls under corporate developments as it discusses Onconetix&#039;s operational progress and clinical advancements for its product Proclarix, crucial for its market strategy.</p>
  </section>

  <section data-block="market-moving">
    <h3>Market-Moving</h3>
    <ul><li>New clinical data enhances Proclarix&#039;s credibility, potentially boosting sales.</li><li>The PRIME study&#039;s results could validate Proclarix for U.S. market entry.</li><li>Partnership with Labcorp expedites U.S. commercialization, attracting investor interest.</li><li>Expanded European presence may increase Proclarix&#039;s market share and revenues.</li></ul>
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  <section data-block="key-facts">
    <h3>Key Facts</h3>
    <ul><li>Proclarix is CE-IVD certified for prostate cancer detection.</li><li>Two studies published showing Proclarix&#039;s superiority in cancer management.</li><li>PRIME study to enroll 500 men, broadening data scope in the U.S.</li><li>Proclarix tests conducted in the UK led to market validation.</li><li>Onconetix&#039;s annual report was filed on March 13, 2026.</li></ul>
  </section>

  <section data-block="trading-thesis">
    <h3>Trading Thesis</h3>
    <p>Investing in ONCO is favorable in the near term as clinical data support market expansion.</p>
  </section>
</section>


<link type="text/css" rel="stylesheet" href="https://www.globenewswire.com/styles/gnw_nitf.css"></link><p align="center"><i>New Clinical Data Reinforce Proclarix&#xAE; Performance in Reducing Overdiagnosis and Unnecessary Biopsies; Multi-Center PRIME Study Initiated in Collaboration with Labcorp; European Commercial Expansion Advances</i></p>  <p align="justify"><b><b>CINCINNATI, Ohio, May  13, 2026  (GLOBE NEWSWIRE) -- </b></b>Onconetix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ONCO">ONCO</a>) ("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&#xAE;, a CE-IVD certified diagnostic blood test used in combination with PSA (prostate-specific antigen) to identify clinically significant prostate cancer ("csPCa").</p>  <p align="justify">Prostate cancer is the most frequently diagnosed male cancer in most countries globally and represents a significant burden to patients and healthcare systems. Proclarix&#xAE; is designed to support clinicians in distinguishing clinically significant from clinically insignificant prostate cancer at an early stage, reducing unnecessary biopsies and overdiagnosis.</p>  <p><b>New Peer-Reviewed Clinical Publications</b></p>  <p align="justify">Two new peer-reviewed scientific publications from a recent clinical study conducted in Denmark further reinforce the clinical utility of Proclarix&#xAE;.</p>  <p align="justify">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&#xAE; 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&#xAE; was shown to significantly reduce overdiagnosis and unnecessary biopsies, outperforming both %fPSA and the ERSPC risk calculator.</p>  <p align="justify">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&#xAE; and its risk score in predicting the transition of patients from active surveillance to active treatment.</p>  <p><b>PRIME Study Initiated with Labcorp</b></p>  <p align="justify">To evaluate Proclarix&#xAE; in the U.S. market and across various ethnicities, PMX has initiated the PRIME study, a multi-center clinical validation study conducted in collaboration with Labcorp Holdings Inc. The first participants have been enrolled, and the study is designed to ultimately include up to 500 men.</p>  <p><b>European Commercial Expansion</b></p>  <p align="justify">PMX continued to advance its commercial presence across Europe during Q1 2026. In the United Kingdom, Proclarix&#xAE; is now offered by a patient organization as an additional option within a real-world screening initiative for early identification of prostate cancer. Close to 100 Proclarix&#xAE; tests were carried out within this initiative in Q1 2026 alone.</p>  <p align="justify">PMX has also identified a collaboration partner in Turkey and continues its efforts to expand market reach into additional European countries.</p>  <p><b>About Onconetix, Inc.</b></p>  <p align="justify">Onconetix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ONCO">ONCO</a>) is a commercial-stage biotechnology company focused on the research, development, and commercialization of innovative oncology solutions. Onconetix owns Proclarix&#xAE;, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union under the IVDR, which it anticipates will be marketed in the U.S. as a lab developed test through its license agreement with Labcorp. For more information, visit <a href="https://www.globenewswire.com/Tracker?data=GipH1K3yhA-NjngMTDYEWcCo57Gykb3LZSqBCvXV-emqeopcxED50OazIlB5yCDrEruMsXZVTkELVK5fB0ghPqNfU26b5L-FbGLgF1AVZ9M=" rel="nofollow" target="_blank">www.onconetix.com</a>.</p>  <p><b>About Proteomedix AG</b></p>  <p align="justify">Proteomedix AG (PMX) is a fully owned Swiss subsidiary of Onconetix, Inc. focused on the development and commercialization of innovative diagnostic solutions for prostate cancer. PMX developed Proclarix&#xAE;, a CE-IVD certified diagnostic blood test that, when used in combination with PSA, supports the early identification of clinically significant prostate cancer. PMX is headquartered in Switzerland. For more information, visit <a href="https://www.globenewswire.com/Tracker?data=qeoJrhjS_oR_yS03_EDf--L-kWYCo2pdUlslGMGs4r6Yevx9dGIuKB0mnwRgSmTOvTA2bavC3udYI4_8jUMEjtpJJZQ7pelG2n9-uUh7dq0=" rel="nofollow" target="_blank">www.proteomedix.com</a>.</p>  <p><b>Forward-Looking Statements</b></p>  <p align="justify">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 are based on Onconetix's current expectations and actual results could differ materially. Investors should read the risk factors set forth in Onconetix's Annual Report on Form 10-K filed with the SEC on March 13, 2026, and periodic reports filed with the SEC on or after the date thereof. All 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 hereof. Onconetix does not undertake an obligation to update or revise any forward-looking statement except as required by applicable law.</p>  <p><b>Investor and Media Contact:</b><br></br>Onconetix, Inc.<br></br>201 E. Fifth Street, Suite 1900<br></br>Cincinnati, OH 45202<br></br>Phone: (513) 620-4101<br></br>Email: <a href="https://www.globenewswire.com/Tracker?data=MHKZ4Hi4KYqHlIp_FNEtcPmgUE7SifAjGrpwSvy5LzG__f80LJ1irpo5mHUlYIPe6amcwmReTZyljjImjdXXsYSFG5qapDFcDU8YuCHMdNjVKENWIACID3o33iolvz0A" rel="nofollow" target="_blank">investors@onconetix.com</a></p> <img alt="" class="__GNW8366DE3E__IMG" src="https://www.globenewswire.com/newsroom/ti?nf=OTcxOTQyNyM3NjAwOTE4IzUwMDEyNjMzNw=="></img> <br></br><img alt="" src="https://ml.globenewswire.com/media/NDdlZmQyY2YtYjc1Ny00M2Q2LWFmMWQtNmFiNmQ3MTE4ZTk3LTUwMDEyNjMzNy0yMDI2LTA1LTEzLWVu/tiny/Onconetix-Inc-.png" referrerpolicy="no-referrer-when-downgrade"></img><p><a href="https://www.globenewswire.com/NewsRoom/AttachmentNg/4824d51d-2ecb-4f49-8b75-fe9b920e7b1c"><img src="https://ml.globenewswire.com/media/4824d51d-2ecb-4f49-8b75-fe9b920e7b1c/small/onconetix-logo-jpg.jpg" border="0" width="150" height="52" alt="Primary Logo"></img></a></p>

Onconetix has made significant strides with Proclarix, its prostate cancer diagnostic, while also launching the PRIME study in partnership with Labcorp to evaluate its efficacy in the U.S. The improved clinical data and strategic European expansion suggest a strong market potential, especially as Proclarix aims to reduce unnecessary procedures.

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

AI Summary

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Trading Thesis

Market-Moving

Key Facts

Companies Mentioned

Corporate Developments

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