{"id":7864,"date":"2024-01-23T10:51:30","date_gmt":"2024-01-23T09:51:30","guid":{"rendered":"https:\/\/amadix.com\/?p=7864"},"modified":"2024-01-23T13:41:03","modified_gmt":"2024-01-23T12:41:03","slug":"la-fda-designa-prevecol-como-dispositivo-disruptivo","status":"publish","type":"post","link":"https:\/\/amadix.com\/es\/news\/la-fda-designa-prevecol-como-dispositivo-disruptivo\/","title":{"rendered":"La FDA designa PreveCol\u00ae como dispositivo disruptivo"},"content":{"rendered":"<ul>\n<li>PreveCol\u00ae, un test en sangre de diagn\u00f3stico oncol\u00f3gico, ha obtenido el reconocimiento estadounidense por su mayor eficacia en la detecci\u00f3n de lesiones precancerosas frente a las alternativas existentes en Estados Unidos<\/li>\n<li>Amadix, primera empresa europea en anunciar la obtenci\u00f3n de la designaci\u00f3n de Breakthrough Device de la FDA para la detecci\u00f3n temprana de c\u00e1ncer colorrectal<\/li>\n<\/ul>\n<p>Amadix, <a href=\"https:\/\/amadix.com\">empresa biotecnol\u00f3gica espa\u00f1ola dedicada a la detecci\u00f3n temprana del c\u00e1ncer<\/a>, anuncia este martes que Prevecol\u00ae, su <strong>an\u00e1lisis de sangre para el cribado del c\u00e1ncer colorrectal<\/strong>, ha recibido la designaci\u00f3n de dispositivo innovador (<strong><em>Breakthrough Device Designation<\/em><\/strong>) por parte de la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (<strong>FDA<\/strong>).<\/p>\n<p>Gracias a este reconocimiento, PreveCol\u00ae adquiere <strong>un acceso acelerado y prioritario<\/strong> en las conversaciones con la FDA durante el proceso de validaci\u00f3n y aprobaci\u00f3n del test para su comercializaci\u00f3n en Estados Unidos.<\/p>\n<p>Para obtener esta distinci\u00f3n, la prueba diagn\u00f3stica espa\u00f1ola PreveCol\u00ae ha demostrado <strong>una mayor eficacia diagn\u00f3stica en la detecci\u00f3n temprana de lesiones precancerosas<\/strong> de c\u00e1ncer colorrectal que las pruebas disponibles en Estados Unidos, lo que supone un beneficio significativo para los pacientes. Con este hito, PreveCol\u00ae se convierte en el primer test europeo en obtener este sello dentro de las pruebas similares.<\/p>\n<p>Seg\u00fan la FDA, el objetivo principal del Programa de <a href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/breakthrough-devices-program\"><em>Breakthrough Device Designation<\/em><\/a> es proporcionar a los pacientes y a los profesionales sanitarios un acceso r\u00e1pido a los dispositivos m\u00e9dicos, <strong>acelerando el desarrollo, la evaluaci\u00f3n y la revisi\u00f3n<\/strong> de los mismos para su validaci\u00f3n y aprobaci\u00f3n previa a la comercializaci\u00f3n. Este programa refleja el s\u00f3lido <strong>compromiso de la FDA con la innovaci\u00f3n y la protecci\u00f3n de la salud p\u00fablica.<\/strong><\/p>\n<p>\u00ab<em>Obtener este reconocimiento por parte de un organismo tan exigente como la FDA es <strong>uno de los hitos m\u00e1s importantes en la historia de nuestra compa\u00f1\u00eda<\/strong>. Nos motiva a seguir trabajando para que los pacientes americanos puedan beneficiarse cuanto antes de PreveCol, y para continuar evitando en la medida de lo posible la aparici\u00f3n del c\u00e1ncer colorrectal y las complicaciones derivadas de los tratamientos que conlleva Con PreveCol\u00ae nos adelantamos al c\u00e1ncer<\/em>\u00ab, ha declarado Roc\u00edo Arroyo, directora general de Amadix.<\/p>\n<h5>Sobre PreveCol\u00ae<\/h5>\n<p><a href=\"https:\/\/amadix.com\/es\/prevecol\/\" target=\"_blank\" rel=\"noopener\">PreveCol\u00ae<\/a> est\u00e1 dirigido a la detecci\u00f3n precoz <strong>en sangre<\/strong> de <strong>biomarcadores asociados a la neoplasia colorrectal<\/strong> y est\u00e1 indicado para el cribado de <strong>adultos, mujeres y hombres, mayores de 45 a\u00f1os<\/strong>, sin s\u00edntomas aparentes.<\/p>\n<p>Un resultado positivo puede indicar la presencia de c\u00e1ncer colorrectal o lesiones precancerosas y debe ir seguido de una colonoscopia diagn\u00f3stica.<\/p>\n<h6><strong>Sobre Amadix<\/strong><\/h6>\n<p>Amadix es una empresa l\u00edder en diagn\u00f3stico molecular centrada en la biopsia l\u00edquida, que desarrolla pruebas diagn\u00f3sticas innovadoras para la detecci\u00f3n precoz del c\u00e1ncer en sangre. La misi\u00f3n de la empresa es alargar la vida de las personas, desarrollando tecnolog\u00edas disruptivas para detectar el tumor a\u00f1os antes de que aparezcan los s\u00edntomas.<\/p>\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/amadix.com\/wp-content\/uploads\/2024\/01\/NdP1_PreveCol-primer-test-europeo-diagnostico-CCR-con-BDD_2024_01_23_DEF.pdf\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Leer la noticia completa<\/strong><\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA designa PreveCol como Breakthrough Device<\/p>\n","protected":false},"author":4,"featured_media":7856,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_joinchat":[],"footnotes":""},"categories":[47],"tags":[],"class_list":["post-7864","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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