{"id":100739,"date":"2024-12-05T16:14:44","date_gmt":"2024-12-05T15:14:44","guid":{"rendered":"https:\/\/www.pcb.ub.edu\/deepull-recibe-la-breakthrough-device-designation-de-la-fda-para-su-test-de-infeccion-del-flujo-sanguineo-ullcore\/"},"modified":"2025-10-13T15:11:48","modified_gmt":"2025-10-13T13:11:48","slug":"deepull-recibe-la-breakthrough-device-designation-de-la-fda-para-su-test-de-infeccion-del-flujo-sanguineo-ullcore","status":"publish","type":"post","link":"https:\/\/www.pcb.ub.edu\/es\/deepull-recibe-la-breakthrough-device-designation-de-la-fda-para-su-test-de-infeccion-del-flujo-sanguineo-ullcore\/","title":{"rendered":"deepull recibe la \u2018Breakthrough Device Designation\u2019 de la FDA para su test de infecci\u00f3n del flujo sangu\u00edneo UllCORE"},"content":{"rendered":"<p><strong>La empresa <a href=\"https:\/\/www.linkedin.com\/company\/deepull\/?originalSubdomain=es\" target=\"_blank\" rel=\"noopener\">deepull<\/a>, que desarrolla soluciones de diagn\u00f3stico sin cultivos para la identificaci\u00f3n r\u00e1pida de pat\u00f3genos, ha recibido la Designaci\u00f3n de Dispositivo Innovador (Breakthrough Device Designation, BDD) de la U.S. Food and Drug Administration (FDA) para su test UllCORE Bloodstream Infection (BSI), dirigido al 95% de los pat\u00f3genos causantes de sepsis. Creada en 2020 en el Parque Cient\u00edfico de Barcelona por los fundadores de STAT-Dx (vendida a QIAGEN en 2018), la compa\u00f1\u00eda ha reunido un equipo de profesionales de talla mundial para crear soluciones de diagn\u00f3stico r\u00e1pidas y accesibles.<\/strong><\/p>\n<p>El test\u00a0<a href=\"https:\/\/deepull.com\/#panel_video0_0\" target=\"_blank\" rel=\"noopener\">UllCORE Bloodstream Infection (BSI)<\/a> de deepull, directo en sangre, detecta en una hora el 95% de los pat\u00f3genos asociados a las infecciones del flujo sangu\u00edneo que pueden provocar sepsis, as\u00ed como determinados factores gen\u00e9ticos determinantes de la resistencia a los antimicrobianos (AMR). El sistema PCR extrae y analiza el ADN microbiano total de 8 ml de sangre, a tiempo real, evitando proceso de hemocultivo que es lento y menos preciso.<\/p>\n<p>Segons <strong>Jordi Carrera<\/strong>, CEO y cofundador de deepull, ha declarado: \u201cEstamos encantados de recibir la designaci\u00f3n de avance de la FDA. Proporcionar en una hora resultados que pueden salvar la vida de pacientes con sospecha de infecci\u00f3n grave representa una ventaja significativa con respecto a los actuales hemocultivos est\u00e1ndar. La identificaci\u00f3n m\u00e1s r\u00e1pida de pat\u00f3genos y las pruebas de AMR proporcionar\u00e1n a los m\u00e9dicos una eficaz herramienta para adaptar con mayor rapidez y precisi\u00f3n la terapia antimicrobiana, lo que podr\u00eda conducir a una recuperaci\u00f3n m\u00e1s r\u00e1pida del paciente, una menor duraci\u00f3n de la estancia hospitalaria y una reducci\u00f3n de la morbilidad y la mortalidad\u201d.<\/p>\n<p>El Programa de Dispositivos Innovadores de la FDA tiene por objeto facilitar a los pacientes un acceso m\u00e1s r\u00e1pido a tecnolog\u00edas innovadoras que permitan un tratamiento o diagn\u00f3stico m\u00e1s eficaz de enfermedades o afecciones potencialmente mortales o irreversiblemente incapacitantes, ayudando a los fabricantes a comercializarlas con mayor rapidez.<\/p>\n<p>Para<strong> Melissa Finocchio,<\/strong> directora de Calidad y Regulaci\u00f3n de deepull, \u201cEl diagn\u00f3stico precoz es fundamental en el tratamiento de multitud de infecciones, pero sobre todo en el caso de la sepsis, donde las pruebas est\u00e1ndar de hemocultivos tardan d\u00edas en realizarse y a menudo no detectan pat\u00f3genos cr\u00edticos. Esta designaci\u00f3n facilita la retroalimentaci\u00f3n temprana y las discusiones interactivas entre deepull y la FDA, lo que nos permite agilizar nuestro proceso de desarrollo y presentaci\u00f3n\u201d.<\/p>\n<div id=\"attachment_100588\" style=\"width: 710px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-100588\" class=\"wp-image-100588\" src=\"https:\/\/www.pcb.ub.edu\/wp-content\/uploads\/2024\/12\/ASABYS.png\" alt=\"\" width=\"700\" height=\"333\" srcset=\"https:\/\/www.pcb.ub.edu\/wp-content\/uploads\/2024\/12\/ASABYS.png 1024w, https:\/\/www.pcb.ub.edu\/wp-content\/uploads\/2024\/12\/ASABYS-300x143.png 300w, https:\/\/www.pcb.ub.edu\/wp-content\/uploads\/2024\/12\/ASABYS-768x365.png 768w\" sizes=\"auto, (max-width: 700px) 100vw, 700px\" \/><p id=\"caption-attachment-100588\" class=\"wp-caption-text\">El test UllCORE BSI se ejecuta en el analizador UllCORE, un sistema de mesa con automatizaci\u00f3n de muestra a resultado. Imagen \/ deepull.<\/p><\/div>\n<p><strong>\u00bb<\/strong>\u00a0<a href=\"https:\/\/www.globenewswire.com\/news-release\/2024\/12\/02\/2989457\/0\/en\/deepull-receives-FDA-Breakthrough-Device-Designation-for-its-UllCORE-Bloodstream-Infection-Test.html\" target=\"_blank\" rel=\"noopener\">M\u00e1s informaci\u00f3 [+]<\/a><br \/>\n<strong>\u00bb<\/strong>\u00a0<a href=\"https:\/\/www.pcb.ub.edu\/es\/sabadell-asabys-invierte-en-deepull-ampliando-su-ronda-de-financiacion-series-b-hasta-los-17me\/\" target=\"_blank\" rel=\"noopener\">Noticia relacionada [+]<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La empresa deepull, que desarrolla soluciones de diagn\u00f3stico sin cultivos para la identificaci\u00f3n r\u00e1pida de pat\u00f3genos, ha recibido la Designaci\u00f3n de Dispositivo Innovador (Breakthrough Device Designation, BDD) de la U.S&#8230;.<\/p>\n","protected":false},"author":4,"featured_media":79934,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[356],"tags":[],"class_list":["post-100739","post","type-post","status-publish","format-standard","has-post-thumbnail","category-empresas"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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