{"id":8630,"date":"2025-05-06T13:20:00","date_gmt":"2025-05-06T11:20:00","guid":{"rendered":"https:\/\/www.mirdetect.de\/?p=8630"},"modified":"2025-10-21T14:19:15","modified_gmt":"2025-10-21T12:19:15","slug":"cobas-z-480","status":"publish","type":"post","link":"https:\/\/www.mirdetect.de\/en\/cobas-z-480\/","title":{"rendered":"cobas z 480"},"content":{"rendered":"
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Bremerhaven, 6 May 2025<\/strong> - The mir|detect GmbH<\/strong> gives the successful Validation and release of the M371-Test on the Roche cobas z 480 system<\/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 six qPCR platforms<\/strong> applicable.<\/p>

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>

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

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Validation confirms high precision and reliability<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The cobas z 480 is technically closely related to the already validated LightCycler 480 II and fulfils all the requirements for precise and standardised performance of the M371-Test<\/strong>. The aim of the validation was to demonstrate the consistent analytical and clinical performance of the test on an additional platform and thus further increase flexibility for clinical laboratories.<\/p>\n

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

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  • Measuring range:<\/strong> 7.45 dm to 15.63 pm<\/li>\n \t
  • limit of detection (LoD):<\/strong> 1.86 dc<\/li>\n \t
  • Limit of quantification (LoQ):<\/strong> 7.45 dc<\/li>\n \t
  • Sensitivity:<\/strong> 100 %<\/li>\n \t
  • Specificity:<\/strong> 100 %<\/li>\n \t
  • PCR efficiency:<\/strong> 90,6 %<\/li>\n \t
  • Linearity:<\/strong> R\u00b2 = 0.997 over six logarithms<\/li>\n \t
  • Cohen's Kappa:<\/strong> 1.000 - perfect match with the clinical diagnosis<\/li>\n<\/ul>
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    All defined acceptance criteria were met. The statistical analysis showed no significant differences between cobas z 480 and LightCycler 480 II. The clinical comparability of both systems is therefore fully guaranteed.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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    More devices, more availability for laboratories<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \"With the validation of the cobas z 480, we are creating an additional option for laboratories that use Roche technology,\" explains Dr Jan Diesend<\/strong>CTO at mir|detect. \"This means that even more users can use the M371-Test<\/strong> into existing processes and take testicular cancer diagnostics in their laboratory to the next level.\"<\/p>

    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 six 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, 6 May 2025 - mir|detect GmbH announces the successful validation and release of the M371-Test on the Roche cobas z 480 system. With this release, 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 can now be used on a total of six qPCR platforms. [...]<\/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-8630","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"\ncobas z 480 - mir|detect<\/title>\n<meta name=\"description\" content=\"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf den cobas z 480 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\/cobas-z-480\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"cobas z 480 - mir|detect\" \/>\n<meta property=\"og:description\" content=\"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf den cobas z 480 und \u00fcberzeugt mit hoher Sensitivit\u00e4t, Spezifit\u00e4t und Pr\u00e4zision.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.mirdetect.de\/en\/cobas-z-480\/\" \/>\n<meta property=\"og:site_name\" content=\"mir|detect\" \/>\n<meta property=\"article:published_time\" content=\"2025-05-06T11:20:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-21T12:19:15+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\\\/cobas-z-480\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/cobas-z-480\\\/\"},\"author\":{\"name\":\"Frank Dorsch\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#\\\/schema\\\/person\\\/1360538a5c60c0f968ceb4bc409e35ed\"},\"headline\":\"cobas z 480\",\"datePublished\":\"2025-05-06T11:20:00+00:00\",\"dateModified\":\"2025-10-21T12:19:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/cobas-z-480\\\/\"},\"wordCount\":352,\"publisher\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#organization\"},\"articleSection\":[\"News\"],\"inLanguage\":\"en-GB\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/cobas-z-480\\\/\",\"url\":\"https:\\\/\\\/www.mirdetect.de\\\/cobas-z-480\\\/\",\"name\":\"cobas z 480 - 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