{"id":827443,"date":"2025-03-19T08:06:31","date_gmt":"2025-03-19T12:06:31","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/"},"modified":"2025-03-19T08:06:31","modified_gmt":"2025-03-19T12:06:31","slug":"onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/","title":{"rendered":"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"justify\">CINCINNATI, March  19, 2025  (GLOBE NEWSWIRE) &#8212;  Onconetix, Inc., (Nasdaq: ONCO) (\u201cOnconetix\u201d or the \u201cCompany\u201d), (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 an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain.<\/p>\n<p align=\"justify\">The presentation, titled, \u201cClinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,\u201d will highlight Proclarix performance results recently obtained from a study including more than 800 patients recruited from Lillebaelt Hospital &#8211; University Hospital of Southern Denmark.<\/p>\n<p align=\"justify\">\u201cThe abstract accepted for presentation at EAU congress will showcase the importance of early detection of prostate cancer, particularly using Proclarix, a biomarker-based blood test,\u201d stated Ralph Schiess, PhD, CEO of Proteomedix, a wholly-owned subsidiary of Onconetix, and added: \u201cProclarix has already demonstrated in multiple studies that it can be safely used to reduce performed biopsies by ruling out patients with clinically insignificant or no prostate cancer while minimizing the risk of missing clinically significant cancer when compared to standard of care.\u201d<\/p>\n<p>Details on the presentation are as follows:<\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"width:23%;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: top\">Presentation Title:<\/td>\n<td style=\"width:77%;border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;text-align: justify;vertical-align: middle;vertical-align: top\">Clinical Performance of Proclarix   in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a   Danish Cohort<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: top\">Presenter:<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;text-align: justify;vertical-align: middle;vertical-align: top\">Zedan Raid A.H, Lillebaelt   Hospital &#8211; University Hospital of Southern Denmark, Department of Oncology,   Vejle, Denmark<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: top\">Session Title:<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: top\">Diagnostic and prognostic biomarkers in prostate cancer<\/td>\n<\/tr>\n<tr>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;vertical-align: top\">Date and Time:<\/td>\n<td style=\"border-right: solid black 1pt;border-bottom: solid black 1pt;vertical-align: top\">March 23, 2025, from 5:15 PM to 6:45 PM CET<\/td>\n<\/tr>\n<\/table>\n<p>\n        <b>About Proclarix<sup>\u00ae<\/sup><\/b>\n      <\/p>\n<p align=\"justify\">Proclarix<sup>\u00ae<\/sup> is CE-certified under In Vitro Diagnostic Regulation (\u201cIVDR\u201d) 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<sup>\u00ae<\/sup> is a risk score combining <i>in-vitro<\/i> assays for the quantitative detection of biomarkers with a proprietary algorithm to assess a patient\u2019s risk of having clinically significant prostate cancer. Detection of prostate cancer-related biomarkers in blood serum using the Proclarix<sup>\u00ae<\/sup> risk score has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of clinically significant prostate cancer. Proclarix<sup>\u00ae<\/sup> is included in both the European (EAU) and American (AUA) guidelines.<\/p>\n<p>\n        <b>About Onconetix, Inc. <\/b>\n      <\/p>\n<p align=\"justify\">Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men\u2019s health and oncology. Through our recent acquisition of\u00a0Proteomedix, we own Proclarix\u00ae, an in vitro diagnostic test for prostate cancer originally developed by\u00a0Proteomedix\u00a0and approved for sale in the\u00a0European Union\u00a0(\u201cEU\u201d) under the IVDR, which we anticipate will be marketed in the\u00a0U.S.\u00a0as a lab developed test (\u201cLDT\u201d) 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 (\u201cBPH\u201d), a disorder of the prostate. For more information, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=O_aJfpYhb8z4uT9nedGfkJ75Twnz4QgXxWbz3QOXyYXsrYJ-lSNr97ti6Maf_BRLzSja7A-4ADcIkftutvZSq8abTKZHj4xV3S4ZlctO8to=\" rel=\"nofollow\" target=\"_blank\">www.onconetix.com<\/a>.<\/p>\n<p>\n        <b>Forward-Looking Statements <\/b>\n      <\/p>\n<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 \u201canticipate,\u201d \u201cbelieve,\u201d \u201cforecast,\u201d \u201cestimate,\u201d \u201cexpect,\u201d and \u201cintend,\u201d among others. These forward-looking statements (including, without limitation, the anticipated results of the Company\u2019s sales and marketing efforts for its commercial stage products as described herein) are based on Onconetix\u2019s 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\u2019s ability to commercialize or monetize Proclarix and integrate the assets and commercial operations acquired in the share exchange with\u00a0Proteomedix; risks related to the Company\u2019s present need for capital to commercially launch Proclarix and have adequate working capital; risks related to Onconetix\u2019s ability to attract, hire and retain skilled personnel necessary to commercialize and operate the Company\u2019s commercial products; the failure to obtain and maintain the necessary regulatory approvals to market and commercialize Onconetix\u2019s products; risks related to the Company\u2019s ability to obtain and maintain intellectual property protection for its current products; whether the Company will be able to maintain compliance with Nasdaq\u2019s applicable listing criteria and the effect of a delisting from Nasdaq on the market for the Company\u2019s securities; and the Company\u2019s 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\u2019s Annual Report on Form 10-K, filed with the\u00a0SEC\u00a0on\u00a0April 11, 2024\u00a0and periodic reports filed with the\u00a0SEC\u00a0on or after the date thereof. All of Onconetix\u2019s 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.<\/p>\n<p>\n        <b>Investor and Media Contact Information: <\/b>\n      <\/p>\n<p>Onconetix, Inc.<br \/> 201 E. Fifth Street, Suite 1900<br \/> Cincinnati, OH\u00a045202<br \/> Phone: (513) 620-4101<\/p>\n<p>Investor Contact Information:<\/p>\n<p>Onconetix Investor Relations<br \/> Email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=sOYC2gUBD5ENPz1I85eUr3Xfxd9XVfklyOYHWh7JH_CZS1LeZJiN6BGWjvNERFJW_yyAmqS4xsC6CfUTak88npiKk4n8zwGswzOaMZ63WjTl40Lr-gyKt06EnpDTaejq\" rel=\"nofollow\" target=\"_blank\">investors@onconetix.com<\/a><\/p>\n<p>\n        \n      <\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM5Njg2MyM2ODEyOTcwIzUwMDEyNjMzNw==\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/ZGI4NWE4ZjYtNWY2My00NDQxLWFlNzItMGI2ZTQzOTIyOThlLTUwMDEyNjMzNy0yMDI1LTAzLTE5LWVu\/tiny\/Onconetix-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CINCINNATI, March 19, 2025 (GLOBE NEWSWIRE) &#8212; Onconetix, Inc., (Nasdaq: ONCO) (\u201cOnconetix\u201d or the \u201cCompany\u201d), (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 an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain. The presentation, titled, \u201cClinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,\u201d will highlight Proclarix performance results recently obtained from a study including more than 800 patients recruited from Lillebaelt Hospital &#8211; University Hospital of Southern Denmark. \u201cThe abstract accepted for presentation at EAU congress will showcase &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-827443","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"CINCINNATI, March 19, 2025 (GLOBE NEWSWIRE) &#8212; Onconetix, Inc., (Nasdaq: ONCO) (\u201cOnconetix\u201d or the \u201cCompany\u201d), (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 an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain. The presentation, titled, \u201cClinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,\u201d will highlight Proclarix performance results recently obtained from a study including more than 800 patients recruited from Lillebaelt Hospital &#8211; University Hospital of Southern Denmark. \u201cThe abstract accepted for presentation at EAU congress will showcase &hellip; Continue reading &quot;Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-19T12:06:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM5Njg2MyM2ODEyOTcwIzUwMDEyNjMzNw==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress\",\"datePublished\":\"2025-03-19T12:06:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\\\/\"},\"wordCount\":888,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTM5Njg2MyM2ODEyOTcwIzUwMDEyNjMzNw==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\\\/\",\"name\":\"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/","og_locale":"en_US","og_type":"article","og_title":"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress - Market Newsdesk","og_description":"CINCINNATI, March 19, 2025 (GLOBE NEWSWIRE) &#8212; Onconetix, Inc., (Nasdaq: ONCO) (\u201cOnconetix\u201d or the \u201cCompany\u201d), (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 an abstract has been accepted for presentation at the 2025 European Association of Urology (EAU) congress taking place March 21-24, 2025, in Madrid, Spain. The presentation, titled, \u201cClinical Performance of Proclarix in Ruling Out Clinically Insignificant or No Prostate Cancer: Evaluation in a Danish Cohort,\u201d will highlight Proclarix performance results recently obtained from a study including more than 800 patients recruited from Lillebaelt Hospital &#8211; University Hospital of Southern Denmark. \u201cThe abstract accepted for presentation at EAU congress will showcase &hellip; Continue reading \"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/","og_site_name":"Market Newsdesk","article_published_time":"2025-03-19T12:06:31+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM5Njg2MyM2ODEyOTcwIzUwMDEyNjMzNw==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress","datePublished":"2025-03-19T12:06:31+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/"},"wordCount":888,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTM5Njg2MyM2ODEyOTcwIzUwMDEyNjMzNw==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/onconetix-announces-new-clinical-data-for-its-innovative-prostate-cancer-test-proclarix-accepted-for-presentation-at-2025-european-association-of-urology-congress\/","name":"Onconetix Announces New Clinical Data for its Innovative Prostate Cancer Test Proclarix Accepted for Presentation at 2025 European Association of Urology Congress - 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