{"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\/tr\/vigilant-biosciences-oral-kanser-tespiti-icin-cok-merkezli-onemli-bir-deneme-icin-klinik-gereksinimler-konusunda-fda-ile-uyum-sagladigini-duyurdu\/","title":{"rendered":"Vigilant Biosciences\u00ae, A\u011f\u0131z Kanseri Tespiti i\u00e7in \u00d6nemli \u00c7ok Merkezli Denemeye Y\u00f6nelik Klinik Gereksinimler Konusunda FDA ile Uyum Sa\u011flad\u0131\u011f\u0131n\u0131 Duyurdu"},"content":{"rendered":"<p>[et_pb_section fb_built=\u201d1\u2033 _builder_version=\u201d4.16\u2033 kilitli=\u201doff\u201d global_colors_info=\u201d{}\u201d][et_pb_row _builder_version=\u201d4.16\u2033 arka plan_size=\u201dinitial\u201d arka plan_position=\u201dtop_left\u201d arka plan_repeat=\u201dtekrar\u201d global_colors_info=\u201d{ }\u201d][et_pb_column type=\u201d4_4\u2033 _builder_version=\u201d4.16\u2033custom_padding=\u201d|||\u201d global_colors_info=\u201d{}\u201dcustom_padding__hover=\u201d|||\u201d][et_pb_text _builder_version=\u201d4.23.1\u2033header_2_font_size=\u201d24px\u201dheader_2_line_height=\u201d1.4em\u201dbackground_size=\u201dinitial\u201dbackground_position=\u201dtop_left\u201dbackground_repeat=\u201drepeat\u201dcustom_padding =\u201d25px||||false|false\u201d global_colors_info=\u201d{}\u201d]<\/p>\n<p class=\"p1\"><b>Lakeway, Teksas <\/b>\u2013 A\u011f\u0131z kanserinin erken te\u015fhisi i\u00e7in yenilik\u00e7i \u00e7\u00f6z\u00fcmler geli\u015ftirmede lider olan Vigilant Biosciences, ABD G\u0131da ve \u0130la\u00e7 Dairesi&#039;nin (FDA), Amerika Birle\u015fik Devletleri ve Avrupa genelinde ger\u00e7ekle\u015ftirilecek \u00e7ok merkezli, \u00f6nemli bir deneme i\u00e7in klinik gereklilikler konusunda anla\u015fmaya vard\u0131\u011f\u0131n\u0131 duyurmaktan mutluluk duyar. Bu \u00e7\u0131\u011f\u0131r a\u00e7an deneme, uzmanlar ve a\u011f\u0131z patologlar\u0131 taraf\u0131ndan do\u011frulanan, a\u011f\u0131z kanseri te\u015fhisi konmu\u015f \u00e7e\u015fitli hasta gruplar\u0131nda Vigilant Biosciences&#039;\u0131n yeni a\u011f\u0131z kanseri tespit teknolojisi BeVigilant\u2122 OraFusion\u2122 Sistemi&#039;nin etkinli\u011fini de\u011ferlendirecektir.<\/p>\n<p class=\"p1\">A\u011f\u0131z kanseri, etkisini vurgulayan endi\u015fe verici istatistiklerle \u00f6nemli bir halk sa\u011fl\u0131\u011f\u0131 sorunu olmaya devam etmektedir. Amerikan Kanser Derne\u011fi&#039;ne g\u00f6re, yaln\u0131zca 2024 y\u0131l\u0131nda Amerika Birle\u015fik Devletleri&#039;nde tahmini 54.540 yeni a\u011f\u0131z bo\u015flu\u011fu ve orofaringeal kanser vakas\u0131n\u0131n te\u015fhis edilmesi beklenmektedir. Ayr\u0131ca, bu vakalar\u0131n yakla\u015f\u0131k 72%&#039;si tedavi se\u00e7eneklerinin s\u0131n\u0131rl\u0131 oldu\u011fu ve sa\u011fkal\u0131m oranlar\u0131n\u0131n \u00f6nemli \u00f6l\u00e7\u00fcde azald\u0131\u011f\u0131 ileri evrelerde te\u015fhis edilmektedir.<\/p>\n<p class=\"p1\">A\u011f\u0131z kanseri vakalar\u0131ndaki art\u0131\u015f endi\u015fe verici bir e\u011filimdir ve D\u00fcnya Sa\u011fl\u0131k \u00d6rg\u00fct\u00fc d\u00fcnya \u00e7ap\u0131nda vaka say\u0131lar\u0131nda art\u0131\u015f oldu\u011funu bildirmektedir. Bu art\u0131\u015fa katk\u0131da bulunan fakt\u00f6rler aras\u0131nda t\u00fct\u00fcn kullan\u0131m\u0131, a\u015f\u0131r\u0131 alkol t\u00fcketimi ve insan papilloma vir\u00fcs\u00fc (HPV) bulunmaktad\u0131r. Vigilant Biosciences, hasta sonu\u00e7lar\u0131n\u0131 ve sa\u011fkal\u0131m oranlar\u0131n\u0131 iyile\u015ftirmek i\u00e7in kritik \u00f6neme sahip olan erken te\u015fhis konusundaki bu acil ihtiyac\u0131 kar\u015f\u0131lamay\u0131 hedeflemektedir.<\/p>\n<p class=\"p1\">Vigilant Biosciences CEO&#039;su Bill Brodie, &quot;FDA&#039;n\u0131n klinik ara\u015ft\u0131rma gerekliliklerimizle uyumlu hale gelmesiyle, a\u011f\u0131z kanserinin te\u015fhis edilme bi\u00e7iminde devrim yaratma potansiyeline sahip \u00f6nemli ara\u015ft\u0131rmam\u0131za devam etmekten heyecan duyuyoruz,&quot; dedi. &quot;Teknolojimiz, ileri evre a\u011f\u0131z kanseri te\u015fhislerinin artan s\u0131kl\u0131\u011f\u0131yla m\u00fccadelede hayati \u00f6nem ta\u015f\u0131yan erken te\u015fhisi kolayla\u015ft\u0131rmak i\u00e7in tasarland\u0131. Sa\u011fl\u0131k profesyonellerine hasta bak\u0131m\u0131n\u0131 iyile\u015ftirmek i\u00e7in ihtiya\u00e7 duyduklar\u0131 ara\u00e7lar\u0131 sa\u011flamaya kararl\u0131y\u0131z.&quot;<\/p>\n<p class=\"p1\">\u00c7ok merkezli bu \u00e7al\u0131\u015fma, geli\u015fmi\u015f g\u00f6r\u00fcnt\u00fcleme ve biyobelirte\u00e7 analizini bir araya getiren son teknoloji bir tespit platformu kullanarak, ABD ve Avrupa&#039;daki \u00f6nde gelen t\u0131p ve di\u015f merkezlerini kapsayacak. Bu \u00e7al\u0131\u015fma, a\u011f\u0131z kanserinin en erken ve tedavi edilebilir evrelerinde tespit edilmesini sa\u011flama yolunda \u00f6nemli bir ad\u0131m te\u015fkil ediyor.<\/p>\n<p class=\"p1\">Vigilant Biosciences, sa\u011fl\u0131k profesyonelleriyle inovasyon ve i\u015f birli\u011fi yoluyla a\u011f\u0131z kanseri tespitini ilerletmeye ve hasta sonu\u00e7lar\u0131n\u0131 iyile\u015ftirmeye kendini adam\u0131\u015ft\u0131r. \u015eirket, deneme ilerledik\u00e7e daha fazla g\u00fcncelleme payla\u015fmay\u0131 d\u00f6rt g\u00f6zle beklemektedir.<\/p>\n<p class=\"p1\"><b>Daha fazla bilgi i\u00e7in l\u00fctfen ileti\u015fime ge\u00e7in:<\/b><\/p>\n<p class=\"p2\"><span class=\"s1\">Dikkatli Biyolojik Bilimler,<\/span> <a href=\"mailto:customerservice@vigilantbiosciences.com\"><span class=\"s2\">m\u00fc\u015fteri hizmetleri@vigilantbiosciences.com<\/span><\/a>, vigilantbiosciences.com<\/p>\n<p class=\"p1\"><b>Vigilant Biosciences Hakk\u0131nda<\/b> Vigilant Biosciences, a\u011f\u0131z kanserinin erken te\u015fhisi i\u00e7in yenilik\u00e7i \u00e7\u00f6z\u00fcmler geli\u015ftirmeye kendini adam\u0131\u015ft\u0131r. En son teknolojiyi kullanarak tan\u0131 do\u011frulu\u011funu art\u0131r\u0131r ve hasta sonu\u00e7lar\u0131n\u0131 iyile\u015ftirir. Misyonumuz, sa\u011fl\u0131k hizmeti sa\u011flay\u0131c\u0131lar\u0131na a\u011f\u0131z kanseriyle etkili bir \u015fekilde m\u00fccadele etmeleri i\u00e7in ihtiya\u00e7 duyduklar\u0131 ara\u00e7lar\u0131 sa\u011flamakt\u0131r.<\/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\/tr\/vigilant-biosciences-oral-kanser-tespiti-icin-cok-merkezli-onemli-bir-deneme-icin-klinik-gereksinimler-konusunda-fda-ile-uyum-sagladigini-duyurdu\/\" \/>\n<meta property=\"og:locale\" content=\"tr_TR\" \/>\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\/tr\/vigilant-biosciences-oral-kanser-tespiti-icin-cok-merkezli-onemli-bir-deneme-icin-klinik-gereksinimler-konusunda-fda-ile-uyum-sagladigini-duyurdu\/\" \/>\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=\"Yazan:\" \/>\n\t<meta name=\"twitter:data1\" content=\"Rachel LaBreck\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tahmini okuma s\u00fcresi\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 dakika\" \/>\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\":\"tr\"},{\"@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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