{"id":801,"date":"2025-09-22T17:16:32","date_gmt":"2025-09-22T17:16:32","guid":{"rendered":"https:\/\/vigilantbiosciences.com\/?p=801"},"modified":"2025-09-25T17:24:14","modified_gmt":"2025-09-25T17:24:14","slug":"vigilant-biosciences-announces-fda-alignment-on-clinical-requirements-for-pivotal-multi-site-trial-for-oral-cancer-detection","status":"publish","type":"post","link":"https:\/\/vigilantbiosciences.com\/de\/vigilant-biosciences-gibt-die-fda-anpassung-der-klinischen-anforderungen-fur-eine-zentrale-multi-site-studie-zur-erkennung-von-mundkrebs-bekannt\/","title":{"rendered":"Vigilant Biosciences\u00ae gibt FDA-Anpassung an klinische Anforderungen f\u00fcr zentrale Multi-Site-Studie zur Erkennung von Mundkrebs bekannt"},"content":{"rendered":"<p>[et_pb_section fb_built=\u201c1\u2033 _builder_version=\u201c4.16\u2033 lock=\u201coff\u201c global_colors_info=\u201c{}\u201c][et_pb_row _builder_version=\u201c4.16\u2033 background_size=\u201cinitial\u201c background_position=\u201ctop_left\u201c background_repeat=\u201crepeat\u201c global_colors_info=\u201c{ }\u201c][et_pb_column type=\u201c4_4\u2033 _builder_version=\u201c4.16\u2033 custom_padding=\u201c|||\u201c global_colors_info=\u201c{}\u201c custom_padding__hover=\u201c|||\u201c][et_pb_text _builder_version=\u201c4.23.1\u2033 header_2_font_size=\u201c24px\u201c header_2_line_height=\u201c1.4em\u201c background_size=\u201cinitial\u201c background_position=\u201ctop_left\u201c background_repeat=\u201crepeat\u201c custom_padding =\u201c25px||||false|false\u201c global_colors_info=\u201c{}\u201c]<\/p>\n<p class=\"p1\"><b>Lakeway, Texas <\/b>Vigilant Biosciences, ein f\u00fchrendes Unternehmen in der Entwicklung innovativer L\u00f6sungen zur Fr\u00fcherkennung von Mundkrebs, gibt bekannt, dass die US-amerikanische Food and Drug Administration (FDA) die klinischen Anforderungen f\u00fcr eine zentrale Multi-Center-Studie in den USA und Europa genehmigt hat. In dieser bahnbrechenden Studie wird die Wirksamkeit der neuartigen Technologie zur Erkennung von Mundkrebs von Vigilant Biosciences, dem BeVigilant\u2122 OraFusion\u2122 System, an einer vielf\u00e4ltigen Patientengruppe mit Mundkrebsdiagnose, best\u00e4tigt durch Fach\u00e4rzte und Oralpathologen, untersucht.<\/p>\n<p class=\"p1\">Mundh\u00f6hlenkrebs stellt nach wie vor ein erhebliches Problem f\u00fcr die \u00f6ffentliche Gesundheit dar, und alarmierende Statistiken unterstreichen seine Auswirkungen. Nach Angaben der American Cancer Society werden allein im Jahr 2024 in den USA voraussichtlich 54.540 neue F\u00e4lle von Mundh\u00f6hlen- und Oropharynxkarzinomen diagnostiziert. Dar\u00fcber hinaus werden etwa 721 dieser F\u00e4lle erst in einem sp\u00e4ten Stadium diagnostiziert, in dem die Behandlungsm\u00f6glichkeiten begrenzt sind und die \u00dcberlebensraten drastisch sinken.<\/p>\n<p class=\"p1\">Die steigende Zahl von Mundkrebserkrankungen ist ein besorgniserregender Trend. Die Weltgesundheitsorganisation meldet weltweit einen Anstieg der F\u00e4lle. Zu den Faktoren, die zu diesem Anstieg beitragen, z\u00e4hlen Tabakkonsum, \u00fcberm\u00e4\u00dfiger Alkoholkonsum und das humane Papillomavirus (HPV). Vigilant Biosciences m\u00f6chte diesem dringenden Bedarf an Fr\u00fcherkennung gerecht werden, die f\u00fcr die Verbesserung der Behandlungsergebnisse und der \u00dcberlebensraten der Patienten entscheidend ist.<\/p>\n<p class=\"p1\">\u201eDa die FDA unsere Anforderungen f\u00fcr klinische Studien best\u00e4tigt hat, freuen wir uns, unsere Zulassungsstudie voranzutreiben. Sie hat das Potenzial, die Mundkrebserkennung zu revolutionieren\u201c, sagte Bill Brodie, CEO von Vigilant Biosciences. \u201eUnsere Technologie erm\u00f6glicht eine fr\u00fchere Diagnose, was entscheidend ist, um der steigenden Zahl von Mundkrebsdiagnosen im Sp\u00e4tstadium entgegenzuwirken. Wir m\u00f6chten medizinischem Fachpersonal die notwendigen Instrumente zur Verf\u00fcgung stellen, um die Patientenversorgung zu verbessern.\u201c<\/p>\n<p class=\"p1\">An der multizentrischen Studie nehmen f\u00fchrende medizinische und zahnmedizinische Zentren in den USA und Europa teil. Dabei kommt eine hochmoderne Erkennungsplattform zum Einsatz, die fortschrittliche Bildgebung und Biomarkeranalyse kombiniert. Diese Studie stellt einen wichtigen Schritt zur Erkennung von Mundkrebs in seinen fr\u00fchesten und behandelbarsten Stadien dar.<\/p>\n<p class=\"p1\">Vigilant Biosciences hat sich zum Ziel gesetzt, die Erkennung von Mundkrebs voranzutreiben und die Behandlungsergebnisse durch Innovation und die Zusammenarbeit mit medizinischem Fachpersonal zu verbessern. Das Unternehmen freut sich darauf, im Verlauf der Studie weitere Updates bekannt zu geben.<\/p>\n<p class=\"p1\"><b>F\u00fcr weitere Informationen wenden Sie sich bitte an:<\/b><\/p>\n<p class=\"p2\"><span class=\"s1\">Vigilant Biosciences,<\/span> <a href=\"mailto:customerservice@vigilantbiosciences.com\"><span class=\"s2\">customerservice@vigilantbiosciences.com<\/span><\/a>, vigilantbiosciences.com<\/p>\n<p class=\"p1\"><b>\u00dcber Vigilant Biosciences<\/b> Vigilant Biosciences entwickelt innovative L\u00f6sungen zur Fr\u00fcherkennung von Mundkrebs und nutzt modernste Technologie, um die Diagnosegenauigkeit zu verbessern und die Behandlungsergebnisse zu optimieren. Unsere Mission ist es, Gesundheitsdienstleistern die notwendigen Instrumente zur effektiven Bek\u00e4mpfung von Mundkrebs an die Hand zu geben.<\/p>\n<p>&nbsp;<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>","protected":false},"excerpt":{"rendered":"<p>Lakeway, TX \u2013 Vigilant Biosciences, a leader in the development of innovative solutions for the early detection of oral cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has aligned on clinical requirements for a pivotal multi-site trial set to take place across the United States and Europe. This groundbreaking trial [&hellip;]<\/p>","protected":false},"author":9,"featured_media":803,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-801","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Vigilant Biosciences\u00ae Announces FDA Alignment on Clinical Requirements for Pivotal Multi-Site Trial for Oral Cancer Detection - Vigilant Biosciences\u00ae<\/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:\/\/vigilantbiosciences.com\/de\/vigilant-biosciences-gibt-die-fda-anpassung-der-klinischen-anforderungen-fur-eine-zentrale-multi-site-studie-zur-erkennung-von-mundkrebs-bekannt\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Vigilant Biosciences\u00ae Announces FDA Alignment on Clinical Requirements for Pivotal Multi-Site Trial for Oral Cancer Detection - Vigilant Biosciences\u00ae\" \/>\n<meta property=\"og:description\" content=\"Patient Resources Understanding the Risk of Oral CancerThe Impact of Oral Cancer In the US alone, oral cancer kills an average one person per hour, 24 hours per day.1Oral cancer is a global challenge with more than 657,000 cases and nearly 330,000 deaths each year1Worldwide 5-year survival rate is only 50% due to delayed intervention [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/vigilantbiosciences.com\/de\/vigilant-biosciences-gibt-die-fda-anpassung-der-klinischen-anforderungen-fur-eine-zentrale-multi-site-studie-zur-erkennung-von-mundkrebs-bekannt\/\" \/>\n<meta property=\"og:site_name\" content=\"Vigilant Biosciences\u00ae\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/VigilantBiosciences1\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-22T17:16:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-09-25T17:24:14+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/vigilantbiosciences.com\/wp-content\/uploads\/VIG_48.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"1500\" \/>\n\t<meta property=\"og:image:height\" content=\"1125\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Rachel LaBreck\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Verfasst von\" \/>\n\t<meta name=\"twitter:data1\" content=\"Rachel LaBreck\" \/>\n\t<meta name=\"twitter:label2\" content=\"Gesch\u00e4tzte Lesezeit\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 Minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/vigilantbiosciences.com\/vigilant-biosciences-announces-fda-alignment-on-clinical-requirements-for-pivotal-multi-site-trial-for-oral-cancer-detection\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/vigilantbiosciences.com\/vigilant-biosciences-announces-fda-alignment-on-clinical-requirements-for-pivotal-multi-site-trial-for-oral-cancer-detection\/\"},\"author\":{\"name\":\"Rachel LaBreck\",\"@id\":\"https:\/\/vigilantbiosciences.com\/#\/schema\/person\/4608808dbb426365f3f8178f8f584753\"},\"headline\":\"Vigilant Biosciences\u00ae Announces FDA Alignment on Clinical Requirements for Pivotal Multi-Site Trial for Oral Cancer Detection\",\"datePublished\":\"2025-09-22T17:16:32+00:00\",\"dateModified\":\"2025-09-25T17:24:14+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/vigilantbiosciences.com\/vigilant-biosciences-announces-fda-alignment-on-clinical-requirements-for-pivotal-multi-site-trial-for-oral-cancer-detection\/\"},\"wordCount\":523,\"publisher\":{\"@id\":\"https:\/\/vigilantbiosciences.com\/#organization\"},\"articleSection\":[\"News\"],\"inLanguage\":\"de-DE\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/vigilantbiosciences.com\/vigilant-biosciences-announces-fda-alignment-on-clinical-requirements-for-pivotal-multi-site-trial-for-oral-cancer-detection\/\",\"url\":\"https:\/\/vigilantbiosciences.com\/vigilant-biosciences-announces-fda-alignment-on-clinical-requirements-for-pivotal-multi-site-trial-for-oral-cancer-detection\/\",\"name\":\"Vigilant Biosciences\u00ae Announces FDA Alignment on Clinical Requirements for Pivotal Multi-Site Trial for Oral Cancer Detection - 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