{"id":24654,"date":"2026-06-23T13:00:00","date_gmt":"2026-06-23T11:00:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=4bfba366d9b406b69d5a8484ca61548f"},"modified":"2026-06-23T13:00:00","modified_gmt":"2026-06-23T11:00:00","slug":"spotlight-medical-secures-ivdr-ce-marking-for-mystage-dx-its-ai-enabled-prognostic-test-for-er-her2-early-breast-cancer","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=24654","title":{"rendered":"Spotlight Medical Secures IVDR CE Marking for myStage Dx, Its AI-Enabled Prognostic Test for ER+\/HER2 \u2013 Early Breast Cancer"},"content":{"rendered":"<ul class=\"bwlistdisc\">\n<li>\n<b>Class C software-only IVD supports European rollout of a JCO-published assay designed to bring clinically validated prognostic assessment into routine breast cancer care.<\/b><\/li>\n<\/ul><p>PARIS--(BUSINESS WIRE)--Spotlight Medical, a Paris-based oncology diagnostics company, today announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017\/746).<\/p><p>\nThe milestone advances Spotlight Medical\u2019s European commercialization strategy and enables implementation of myStage Dx with oncology centers, pathology laboratories and digital pathology partners.<\/p><p>\nIn ER+\/HER2\u2212 early breast cancer, physicians increasingly need to weigh the potential benefit of treatment intensification against long-term safety, quality of life and the risk of overtreatment. Many patients are still stratified using broad clinical and pathological criteria, which may not fully capture their individual risk of distant recurrence.<\/p><p>\nmyStage Dx was developed to support more precise, physician-led risk stratification in routine care. The AI-enabled test analyzes a digitized H&amp;E-stained FFPE whole slide image of the primary breast cancer, together with routinely available clinicopathological variables. Using predefined and explainable features, it generates a binary prognostic classification: Low Risk or Not Low Risk.<\/p><p>\nClinical evidence supporting myStage Dx was published in the Journal of Clinical Oncology<sup>.<\/sup> In blinded validation studies across the prospective CANTO and UNIRAD cohorts, the test identified 19.4% of patients with clinically high-risk ER+\/HER2\u2212 early breast cancer as Low Risk. At nine years, 95.4% of patients classified as Low Risk remained free of distant recurrence and breast cancer\u2013related death, compared with 76.8% for the Not Low Risk group.<\/p><p>\n<i>\u201cSecuring CE marking under IVDR is a major milestone for Spotlight Medical as we prepare to bring myStage Dx to clinicians across Europe,\u201d<\/i> said <b>Sylvain Berlemont, CEO of Spotlight Medical<\/b>. <i>\u201cThe test was designed for practical integration into routine oncology and pathology workflows, using standard H&amp;E slides and baseline clinicopathological data to provide physicians with a clear prognostic classification. This regulatory achievement gives us a strong foundation to support clinical adoption and to roll out myStage Dx across European hospitals.\u201d<\/i><\/p><p>\nAs part of the IVDR conformity assessment, Spotlight Medical completed a performance evaluation package addressing scientific validity, analytical performance and clinical performance, together with software verification and validation, risk management, cybersecurity, post-market surveillance and AI lifecycle documentation.<\/p><p>\n<b>About myStage Dx<\/b><\/p><p>\nmyStage Dx is a CE-marked, Class C, software-only in vitro diagnostic medical device developed by Spotlight Medical. It is intended to assess the risk of distant metastasis within nine years from diagnosis in adult patients with stage II\u2013III, node-positive, ER-positive, HER2-negative breast cancer. The test analyzes a digitized H&amp;E whole slide image and baseline clinicopathological variables, generating a binary prognostic classification for use by qualified physicians.<\/p><p>\nmyStage Dx is intended for professional use only.<\/p><p>\n<b>Related peer-reviewed publication<\/b><\/p><p>\n\u201cIdentifying Patients With Low Relapse Rate Despite High-Risk Estrogen Receptor\u2013Positive\/Human Epidermal Growth Factor Receptor 2\u2013Negative Early Breast Cancer: Development and Validation of a Clinicopathologic Assay.\u201d Bidard et al., Journal of Clinical Oncology, 2025.<\/p><p>\n<b>About Spotlight Medical<\/b><\/p><p>\nSpotlight Medical is a French oncology diagnostics company developing evidence-driven, clinical-grade AI tests to support more precise cancer care. The company combines routine pathology, clinical data and explainable AI to develop prognostic assays designed for practical adoption in oncology workflows.<\/p><p>\nFor more information, visit <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fspotlightmedical.com&amp;esheet=54557948&amp;newsitemid=20260623685284&amp;lan=en-US&amp;anchor=spotlightmedical.com&amp;index=1&amp;md5=10483588968aec148ad07817f85c4b08\" rel=\"nofollow\" shape=\"rect\">spotlightmedical.com<\/a> and <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fmystagedx.com&amp;esheet=54557948&amp;newsitemid=20260623685284&amp;lan=en-US&amp;anchor=mystagedx.com&amp;index=2&amp;md5=053af438d28fa6fa2154be1261c0df00\" rel=\"nofollow\" shape=\"rect\">mystagedx.com<\/a>.<\/p><p>\nFollow Spotlight Medical on <a  href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fspotlight-medical&amp;esheet=54557948&amp;newsitemid=20260623685284&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=3&amp;md5=047d0837f2e005f5e7a58c0b58457d04\" rel=\"nofollow\" shape=\"rect\">LinkedIn<\/a>.<\/p><br\/> <b>Contacts<\/b> <br\/><p>\n<b>Media Contact\n<br\/>For media enquiries: <a  href=\"mailto:press@spotlightmedical.com\" rel=\"nofollow\" shape=\"rect\">press@spotlightmedical.com<\/a>.<\/b><br\/><\/p><p>\n<b>MAARC \u2013 Press Relations<\/b><br\/>Bruno Arabian \/ +33 (0) 6 87 88 47 26 \/ <a  href=\"mailto:bruno.arabian@maarc.fr\" rel=\"nofollow\" shape=\"rect\">bruno.arabian@maarc.fr<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Class C software-only IVD supports European rollout of a JCO-published assay designed to bring clinically validated prognostic assessment into routine breast cancer care.<br \/>\nPARIS&#8211;(BUSINESS WIRE)&#8211;Spotlight Medical, a Paris-based oncology diagnostics c&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-24654","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/24654","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=24654"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/24654\/revisions"}],"predecessor-version":[{"id":24655,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/24654\/revisions\/24655"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=24654"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=24654"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=24654"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}