{"id":8642,"date":"2025-09-23T14:03:00","date_gmt":"2025-09-23T12:03:00","guid":{"rendered":"https:\/\/www.mirdetect.de\/?p=8642"},"modified":"2025-10-21T14:19:54","modified_gmt":"2025-10-21T12:19:54","slug":"quantstudio-5-dx","status":"publish","type":"post","link":"https:\/\/www.mirdetect.de\/en\/quantstudio-5-dx\/","title":{"rendered":"QuantStudio 5 Dx"},"content":{"rendered":"
\n\t\t\t\t
\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Bremerhaven, 23 September 2025<\/strong> - The mir|detect GmbH<\/strong> gives the successful Validation and release of the M371-Test QuantStudio 5 Dx from Thermo Fisher Scientific<\/strong> was announced. With this approval, the CE-IVD-certified blood test for testicular cancer is now available on another widely used qPCR platform. This means that the CE-IVD-certified blood test for testicular cancer is now available on a total of seven qPCR platforms<\/strong> applicable.<\/p>\n

This extension makes the test accessible to an even wider range of laboratories and supports the standardised, reliable and rapid diagnosis of testicular germ cell tumours (TGCTs) in Europe and beyond.<\/p>\n

The new instructions for use are available in our Download area<\/strong><\/a> available.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t
\n\t\t\t\t\t
Validation confirms high precision and reliability<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

The QuantStudio 5 Dx<\/strong> is both FDA-approved<\/strong> as well as CE-marked<\/strong> and enables the M371-Test to be used in routine clinical laboratories worldwide. The aim of the validation was to demonstrate the analytical and clinical performance of the M371-Test on this platform and to further expand device compatibility.<\/p>\n

Key performance data:<\/strong><\/p>\n

    \n
  • Measuring range:<\/strong> 3.73 fM to 15.63 pM<\/li>\n
  • limit of detection (LoD):<\/strong> 1.86 dc<\/li>\n
  • Limit of quantification (LoQ):<\/strong> 3.73 dc<\/li>\n
  • Sensitivity:<\/strong> 100 %<\/li>\n
  • Specificity:<\/strong> 100 %<\/li>\n
  • PCR efficiency:<\/strong> 92,8 %<\/li>\n
  • Linearity:<\/strong> R\u00b2 = 0.992 over six logarithms<\/li>\n
  • Cohen's Kappa:<\/strong> 1.000 - perfect match with the clinical diagnosis<\/li>\n<\/ul>\n

    \u00a0<\/p>\n

    All acceptance criteria were met. The statistical analysis confirmed a high level of precision and complete clinical agreement between QuantStudio 5 Dx and the previous comparison platform.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

    \n\t\t\t\t
    \n\t\t\t\t\t
    More devices, more availability for laboratories<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
    \n\t\t\t\t
    \n\t\t\t\t\t\t\t\t\t

    \"With the validation of the QuantStudio 5 Dx, the M371-Test<\/strong> available for the first time on a platform that is approved for both research and clinical use,\" explains Dr Jan Diesend<\/strong>CTO at mir|detect. \"This opens up new possibilities for laboratories to easily integrate the test into existing processes - with consistently high diagnostic quality.\"<\/p>\n

    The validation was carried out in accordance with the Regulation (EU) 2017\/746 IVDR<\/strong> and approved by the Notified Body. The M371-Test<\/strong> is now validated on seven qPCR systems. This broad compatibility enables easy implementation without additional hardware investment and ensures consistent test performance across different platforms.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

    Bremerhaven, 23. September 2025 \u2013\u00a0Die mir|detect GmbH gibt die erfolgreiche Validierung und Freigabe des M371-Tests QuantStudio 5 Dx von Thermo Fisher Scientific bekannt. Mit dieser Freigabe steht der CE-IVD-zertifizierte Bluttest f\u00fcr Hodenkrebs nun auf einer weiteren weit verbreiteten qPCR-Plattform zur Verf\u00fcgung. Damit ist der CE-IVD-zertifizierte Bluttest f\u00fcr Hodenkrebs nun auf insgesamt sieben qPCR-Plattformen einsetzbar. Diese […]<\/p>","protected":false},"author":10,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":"","_wp_rev_ctl_limit":""},"categories":[1],"tags":[],"class_list":["post-8642","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"\nQuantStudio 5 Dx - mir|detect<\/title>\n<meta name=\"description\" content=\"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf dem QuantStudio 5 Dx und \u00fcberzeugt mit hoher Sensitivit\u00e4t, Spezifit\u00e4t und Pr\u00e4zision\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.mirdetect.de\/en\/quantstudio-5-dx\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"QuantStudio 5 Dx - mir|detect\" \/>\n<meta property=\"og:description\" content=\"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf dem QuantStudio 5 Dx und \u00fcberzeugt mit hoher Sensitivit\u00e4t, Spezifit\u00e4t und Pr\u00e4zision\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.mirdetect.de\/en\/quantstudio-5-dx\/\" \/>\n<meta property=\"og:site_name\" content=\"mir|detect\" \/>\n<meta property=\"article:published_time\" content=\"2025-09-23T12:03:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-21T12:19:54+00:00\" \/>\n<meta name=\"author\" content=\"Frank Dorsch\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Frank Dorsch\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/\"},\"author\":{\"name\":\"Frank Dorsch\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#\\\/schema\\\/person\\\/1360538a5c60c0f968ceb4bc409e35ed\"},\"headline\":\"QuantStudio 5 Dx\",\"datePublished\":\"2025-09-23T12:03:00+00:00\",\"dateModified\":\"2025-10-21T12:19:54+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/\"},\"wordCount\":339,\"publisher\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#organization\"},\"articleSection\":[\"News\"],\"inLanguage\":\"en-GB\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/\",\"url\":\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/\",\"name\":\"QuantStudio 5 Dx - mir|detect\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#website\"},\"datePublished\":\"2025-09-23T12:03:00+00:00\",\"dateModified\":\"2025-10-21T12:19:54+00:00\",\"description\":\"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf dem QuantStudio 5 Dx und \u00fcberzeugt mit hoher Sensitivit\u00e4t, Spezifit\u00e4t und Pr\u00e4zision\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/quantstudio-5-dx\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/www.mirdetect.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"QuantStudio 5 Dx\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#website\",\"url\":\"https:\\\/\\\/www.mirdetect.de\\\/\",\"name\":\"mir|detect\",\"description\":\"Die Zukunft der Hodenkrebsdiagnostik\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.mirdetect.de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-GB\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#organization\",\"name\":\"mir|detect\",\"url\":\"https:\\\/\\\/www.mirdetect.de\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"mir|detect\"},\"image\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.instagram.com\\\/soelarenergie\\\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#\\\/schema\\\/person\\\/1360538a5c60c0f968ceb4bc409e35ed\",\"name\":\"Frank Dorsch\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/2face0bfe7dbc8eb06d60377dfe4a041a5a74056e2754fd50c96ad69860b9c6a?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/2face0bfe7dbc8eb06d60377dfe4a041a5a74056e2754fd50c96ad69860b9c6a?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/2face0bfe7dbc8eb06d60377dfe4a041a5a74056e2754fd50c96ad69860b9c6a?s=96&d=mm&r=g\",\"caption\":\"Frank Dorsch\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"QuantStudio 5 Dx - mir|detect","description":"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf dem QuantStudio 5 Dx und \u00fcberzeugt mit hoher Sensitivit\u00e4t, Spezifit\u00e4t und Pr\u00e4zision","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.mirdetect.de\/en\/quantstudio-5-dx\/","og_locale":"en_GB","og_type":"article","og_title":"QuantStudio 5 Dx - mir|detect","og_description":"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf dem QuantStudio 5 Dx und \u00fcberzeugt mit hoher Sensitivit\u00e4t, Spezifit\u00e4t und Pr\u00e4zision","og_url":"https:\/\/www.mirdetect.de\/en\/quantstudio-5-dx\/","og_site_name":"mir|detect","article_published_time":"2025-09-23T12:03:00+00:00","article_modified_time":"2025-10-21T12:19:54+00:00","author":"Frank Dorsch","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Frank Dorsch","Estimated reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.mirdetect.de\/quantstudio-5-dx\/#article","isPartOf":{"@id":"https:\/\/www.mirdetect.de\/quantstudio-5-dx\/"},"author":{"name":"Frank Dorsch","@id":"https:\/\/www.mirdetect.de\/#\/schema\/person\/1360538a5c60c0f968ceb4bc409e35ed"},"headline":"QuantStudio 5 Dx","datePublished":"2025-09-23T12:03:00+00:00","dateModified":"2025-10-21T12:19:54+00:00","mainEntityOfPage":{"@id":"https:\/\/www.mirdetect.de\/quantstudio-5-dx\/"},"wordCount":339,"publisher":{"@id":"https:\/\/www.mirdetect.de\/#organization"},"articleSection":["News"],"inLanguage":"en-GB"},{"@type":"WebPage","@id":"https:\/\/www.mirdetect.de\/quantstudio-5-dx\/","url":"https:\/\/www.mirdetect.de\/quantstudio-5-dx\/","name":"QuantStudio 5 Dx - mir|detect","isPartOf":{"@id":"https:\/\/www.mirdetect.de\/#website"},"datePublished":"2025-09-23T12:03:00+00:00","dateModified":"2025-10-21T12:19:54+00:00","description":"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf dem QuantStudio 5 Dx und \u00fcberzeugt mit hoher Sensitivit\u00e4t, Spezifit\u00e4t und Pr\u00e4zision","breadcrumb":{"@id":"https:\/\/www.mirdetect.de\/quantstudio-5-dx\/#breadcrumb"},"inLanguage":"en-GB","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.mirdetect.de\/quantstudio-5-dx\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.mirdetect.de\/quantstudio-5-dx\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.mirdetect.de\/"},{"@type":"ListItem","position":2,"name":"QuantStudio 5 Dx"}]},{"@type":"WebSite","@id":"https:\/\/www.mirdetect.de\/#website","url":"https:\/\/www.mirdetect.de\/","name":"mir|detect","description":"The future of testicular cancer diagnostics","publisher":{"@id":"https:\/\/www.mirdetect.de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.mirdetect.de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-GB"},{"@type":"Organization","@id":"https:\/\/www.mirdetect.de\/#organization","name":"mir|detect","url":"https:\/\/www.mirdetect.de\/","logo":{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/www.mirdetect.de\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"mir|detect"},"image":{"@id":"https:\/\/www.mirdetect.de\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.instagram.com\/soelarenergie\/"]},{"@type":"Person","@id":"https:\/\/www.mirdetect.de\/#\/schema\/person\/1360538a5c60c0f968ceb4bc409e35ed","name":"Frank Dorsch","image":{"@type":"ImageObject","inLanguage":"en-GB","@id":"https:\/\/secure.gravatar.com\/avatar\/2face0bfe7dbc8eb06d60377dfe4a041a5a74056e2754fd50c96ad69860b9c6a?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/2face0bfe7dbc8eb06d60377dfe4a041a5a74056e2754fd50c96ad69860b9c6a?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/2face0bfe7dbc8eb06d60377dfe4a041a5a74056e2754fd50c96ad69860b9c6a?s=96&d=mm&r=g","caption":"Frank Dorsch"}}]}},"_links":{"self":[{"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/posts\/8642","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/comments?post=8642"}],"version-history":[{"count":0,"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/posts\/8642\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/media?parent=8642"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/categories?post=8642"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.mirdetect.de\/en\/wp-json\/wp\/v2\/tags?post=8642"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}