{"id":8580,"date":"2025-04-08T12:13:00","date_gmt":"2025-04-08T10:13:00","guid":{"rendered":"https:\/\/www.mirdetect.de\/?p=8580"},"modified":"2025-10-21T13:30:09","modified_gmt":"2025-10-21T11:30:09","slug":"lightcycler-pro-cfx96","status":"publish","type":"post","link":"https:\/\/www.mirdetect.de\/en\/lightcycler-pro-cfx96\/","title":{"rendered":"LightCycler PRO &amp; CFX96"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"8580\" class=\"elementor elementor-8580\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b5f726e e-flex e-con-boxed e-con e-parent\" data-id=\"b5f726e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d623f1f elementor-widget elementor-widget-text-editor\" data-id=\"d623f1f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"210\" data-end=\"581\"><strong data-start=\"210\" data-end=\"243\">Bremerhaven, 8 April 2025<\/strong> - The <strong data-start=\"356\" data-end=\"375\">mir|detect GmbH<\/strong> gives the successful <strong data-start=\"398\" data-end=\"441\">Validation and release of the M371-Test<\/strong> known on two other qPCR systems: the <strong data-start=\"487\" data-end=\"506\">LightCycler PRO<\/strong> from Roche and the <strong data-start=\"525\" data-end=\"534\">CFX96<\/strong> from Bio-Rad. Both devices were fully approved as part of a comprehensive analytical and clinical evaluation. This means that the CE-IVD-certified blood test for testicular cancer is now available on a total of <strong data-start=\"736\" data-end=\"761\">Five qPCR platforms<\/strong> applicable.<\/p><p data-start=\"777\" data-end=\"1014\">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><p data-start=\"1246\" data-end=\"1554\">The new instructions for use are available in our <a href=\"https:\/\/www.mirdetect.de\/en\/download\/\" target=\"_blank\" rel=\"noopener\"><strong>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<div class=\"elementor-element elementor-element-fcd4e77 elementor-widget elementor-widget-heading\" data-id=\"fcd4e77\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Validation confirms high precision and reliability<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-102d914 elementor-widget elementor-widget-text-editor\" data-id=\"102d914\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1082\" data-end=\"1352\">The validation included extensive tests on detection limit, linearity, precision and diagnostic accuracy. Both devices met all predefined acceptance criteria and showed a high level of conformity with the LightCycler 480 II reference system.<\/p><p data-start=\"1354\" data-end=\"1398\"><strong data-start=\"1354\" data-end=\"1398\">Key performance data:<\/strong><\/p><ul data-start=\"1400\" data-end=\"1817\"><li data-start=\"1400\" data-end=\"1441\"><p data-start=\"1402\" data-end=\"1441\"><strong data-start=\"1402\" data-end=\"1418\">Measuring range:<\/strong> 9.93 fM to 15.63 pM<\/p><\/li><li data-start=\"1442\" data-end=\"1479\"><p data-start=\"1444\" data-end=\"1479\"><strong data-start=\"1444\" data-end=\"1469\">limit of detection (LoD):<\/strong> 2.48 dc<\/p><\/li><li data-start=\"1480\" data-end=\"1525\"><p data-start=\"1482\" data-end=\"1525\"><strong data-start=\"1482\" data-end=\"1515\">Limit of quantification (LoQ):<\/strong> 9.93 dc<\/p><\/li><li data-start=\"1526\" data-end=\"1589\"><p data-start=\"1528\" data-end=\"1589\"><strong data-start=\"1528\" data-end=\"1545\">Sensitivity:<\/strong> 91.4 % (LightCycler PRO) | 94.3 % (CFX96)<\/p><\/li><li data-start=\"1590\" data-end=\"1630\"><p data-start=\"1592\" data-end=\"1630\"><strong data-start=\"1592\" data-end=\"1607\">Specificity:<\/strong> 100 % (both devices)<\/p><\/li><li data-start=\"1631\" data-end=\"1696\"><p data-start=\"1633\" data-end=\"1696\"><strong data-start=\"1633\" data-end=\"1651\">PCR efficiency:<\/strong> 102.1 % (LightCycler PRO) | 98.1 % (CFX96)<\/p><\/li><li data-start=\"1697\" data-end=\"1761\"><p data-start=\"1699\" data-end=\"1761\"><strong data-start=\"1699\" data-end=\"1735\">Diagnostic accuracy (AUC):<\/strong> 0.997 for both systems<\/p><\/li><li data-start=\"1762\" data-end=\"1817\"><p data-start=\"1764\" data-end=\"1817\"><strong data-start=\"1764\" data-end=\"1805\">Precision (total standard deviation):<\/strong> \u2264 0.44 CT<\/p><\/li><\/ul><p data-start=\"1819\" data-end=\"2071\">These results confirm the same analytical performance of the <strong>M371-Test<\/strong> on both platforms. The measured agreement with the clinical diagnosis was 92 % (Cohen's \u03ba = 0.92) and emphasises the diagnostic reliability.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a5cbd5d elementor-widget elementor-widget-heading\" data-id=\"a5cbd5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">More devices, more availability for laboratories<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0ebaee9 elementor-widget elementor-widget-text-editor\" data-id=\"0ebaee9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"2125\" data-end=\"2325\">With the extension to LightCycler PRO and CFX96, laboratories that already use these widely used devices can now also use the <strong>M371-Test<\/strong> without additional hardware investment.<\/p><p data-start=\"2327\" data-end=\"2744\">\"The release on these two platforms was an important step towards further simplifying the application of our test,\" explains <strong>Dr Jan Diesend<\/strong>CTO at mir|detect. \"Many laboratories already have CFX96 or LightCycler systems. With this validation, we enable them to get started directly with miRNA-based tumour diagnostics - without having to adapt their infrastructure.\"<\/p><p data-start=\"2746\" data-end=\"3105\">The validation was carried out entirely in accordance with the <strong data-start=\"2802\" data-end=\"2824\">Regulation (EU) 2017\/746 IVDR<\/strong> and approved by the Notified Body. It confirms that the analytical and clinical performance of the <strong>M371-Test<\/strong> on both devices is equivalent to the already approved systems (LightCycler 480 II, QuantStudio 5 and AriaDx).<\/p><p data-start=\"3473\" data-end=\"3706\">By extending platform compatibility, the test will be available in even more clinical laboratories in future - an important step towards integrating modern molecular diagnostics more closely into everyday clinical practice.<\/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":"<p>Bremerhaven, 8. April 2025 \u2013\u00a0Die mir|detect GmbH gibt die erfolgreiche Validierung und Freigabe des M371-Tests auf zwei weiteren qPCR-Systemen bekannt: dem LightCycler PRO von Roche und dem CFX96 von Bio-Rad. Beide Ger\u00e4te wurden im Rahmen einer umfassenden analytischen und klinischen Bewertung vollst\u00e4ndig freigegeben. Damit ist der CE-IVD-zertifizierte Bluttest f\u00fcr Hodenkrebs nun auf insgesamt f\u00fcnf qPCR-Plattformen [&hellip;]<\/p>\n","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-8580","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>LightCycler PRO &amp; CFX96 - mir|detect<\/title>\n<meta name=\"description\" content=\"mir|detect erweitert den CE-IVD-zertifizierten M371-Test auf LightCycler PRO und CFX96 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\/lightcycler-pro-cfx96\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"LightCycler PRO &amp; 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