{"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\/nl\/vigilant-biosciences-kondigt-fda-afstemming-aan-over-klinische-vereisten-voor-cruciale-multisite-studie-voor-de-detectie-van-mondkanker\/","title":{"rendered":"Vigilant Biosciences\u00ae kondigt FDA-afstemming aan over klinische vereisten voor cruciale multi-site-studie voor de detectie van mondkanker"},"content":{"rendered":"<p>[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d4.16\u2033locked=\u201doff\u201d global_colors_info=\u201d{}\u201d][et_pb_row _builder_version=\u201d4.16\u2033 background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d global_colors_info=\u201d{ }\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d4.16\u2033 custom_padding=\u201d|||\u201d global_colors_info=\u201d{}\u201d custom_padding__hover=\u201d|||\u201d][et_pb_text _builder_version=\u201d4.23.1\u2033 header_2_font_size=\u201d24px\u201d header_2_line_height=\u201d1.4em\u201d background_size=\u201dinitial\u201d background_position=\u201dtop_left\u201d background_repeat=\u201drepeat\u201d custom_padding =\u201d25px||||false|false\u201d global_colors_info=\u201d{}\u201d]<\/p>\n<p class=\"p1\"><b>Lakeway, TX <\/b>\u2013 Vigilant Biosciences, toonaangevend in de ontwikkeling van innovatieve oplossingen voor de vroege opsporing van mondkanker, kondigt met genoegen aan dat de Amerikaanse Food and Drug Administration (FDA) de klinische vereisten heeft vastgesteld voor een cruciale multi-site studie die in de Verenigde Staten en Europa zal plaatsvinden. Deze baanbrekende studie zal de werkzaamheid evalueren van Vigilant Biosciences&#039; nieuwe technologie voor de detectie van mondkanker, het BeVigilant\u2122 OraFusion\u2122-systeem, in een diverse groep pati\u00ebnten met de diagnose mondkanker, bevestigd door specialisten en mondpathologen.<\/p>\n<p class=\"p1\">Mondkanker blijft een groot probleem voor de volksgezondheid, met alarmerende statistieken die de impact ervan benadrukken. Volgens de American Cancer Society zullen er naar verwachting alleen al in 2024 in de Verenigde Staten 54.540 nieuwe gevallen van mondholte- en orofaryngeale kanker worden vastgesteld. Bovendien worden ongeveer 72% van deze gevallen in een laat stadium gediagnosticeerd, waardoor de behandelingsopties beperkt zijn en de overlevingskansen drastisch afnemen.<\/p>\n<p class=\"p1\">De stijgende incidentie van mondkanker is een zorgwekkende trend. De Wereldgezondheidsorganisatie meldt wereldwijd een toename van het aantal gevallen. Factoren die bijdragen aan deze stijging zijn onder meer tabaksgebruik, overmatig alcoholgebruik en het humaan papillomavirus (HPV). Vigilant Biosciences wil inspelen op deze dringende behoefte aan vroege opsporing, die cruciaal is voor het verbeteren van pati\u00ebntresultaten en overlevingskansen.<\/p>\n<p class=\"p1\">&quot;Nu de FDA zich heeft gecommitteerd aan onze eisen voor klinische studies, zijn we verheugd om door te gaan met onze cruciale studie, die de potentie heeft om de manier waarop mondkanker wordt opgespoord radicaal te veranderen&quot;, aldus Bill Brodie, CEO van Vigilant Biosciences. &quot;Onze technologie is ontworpen om een vroegere diagnose mogelijk te maken, wat essentieel is in de strijd tegen de toenemende incidentie van mondkanker in een laat stadium. We zetten ons in om zorgprofessionals de tools te bieden die ze nodig hebben om de pati\u00ebntenzorg te verbeteren.&quot;<\/p>\n<p class=\"p1\">De studie op meerdere locaties zal worden uitgevoerd door toonaangevende medische en tandheelkundige centra in de VS en Europa, met behulp van een state-of-the-art detectieplatform dat geavanceerde beeldvorming en biomarkeranalyse combineert. Deze studie is een belangrijke stap in de richting van het detecteren van mondkanker in de vroegste en meest behandelbare stadia.<\/p>\n<p class=\"p1\">Vigilant Biosciences zet zich in voor het verbeteren van de detectie van mondkanker en het verbeteren van pati\u00ebntresultaten door middel van innovatie en samenwerking met zorgprofessionals. Het bedrijf kijkt ernaar uit om verdere updates te delen naarmate het onderzoek vordert.<\/p>\n<p class=\"p1\"><b>Voor meer informatie kunt u contact opnemen met:<\/b><\/p>\n<p class=\"p2\"><span class=\"s1\">Waakzame Biowetenschappen,<\/span> <a href=\"mailto:customerservice@vigilantbiosciences.com\"><span class=\"s2\">klantenservice@vigilantbiosciences.com<\/span><\/a>, vigilantbiosciences.com<\/p>\n<p class=\"p1\"><b>Over Vigilant Biosciences<\/b> Vigilant Biosciences zet zich in voor de ontwikkeling van innovatieve oplossingen voor vroege opsporing van mondkanker. We maken daarbij gebruik van geavanceerde technologie om de diagnostische nauwkeurigheid te verbeteren en de pati\u00ebntresultaten te verbeteren. Onze missie is om zorgverleners te voorzien van de tools die ze nodig hebben om mondkanker effectief te bestrijden.<\/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\/nl\/vigilant-biosciences-kondigt-fda-afstemming-aan-over-klinische-vereisten-voor-cruciale-multisite-studie-voor-de-detectie-van-mondkanker\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\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\/nl\/vigilant-biosciences-kondigt-fda-afstemming-aan-over-klinische-vereisten-voor-cruciale-multisite-studie-voor-de-detectie-van-mondkanker\/\" \/>\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=\"Geschreven door\" \/>\n\t<meta name=\"twitter:data1\" content=\"Rachel LaBreck\" \/>\n\t<meta name=\"twitter:label2\" content=\"Geschatte leestijd\" \/>\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\":\"nl-NL\"},{\"@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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