{"id":45429,"date":"2022-06-23T16:01:52","date_gmt":"2022-06-23T14:01:52","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/paige-answers-call-to-better-identify-breast-cancer-patients-with-low-expression-of-her2\/"},"modified":"2022-06-23T16:01:52","modified_gmt":"2022-06-23T14:01:52","slug":"paige-answers-call-to-better-identify-breast-cancer-patients-with-low-expression-of-her2","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/paige-answers-call-to-better-identify-breast-cancer-patients-with-low-expression-of-her2\/","title":{"rendered":"Paige Answers Call to Better Identify Breast Cancer Patients with Low Expression of HER2"},"content":{"rendered":"
\n

\nCompany <\/i>announces CE-IVD <\/i>and UKCA designations<\/i> of <\/i>its <\/i>new digital biomarker assay, <\/i>HER2Complete,<\/i> to identify patients with expression of HER2 in breast cancer<\/i> <\/i>\n<\/p>\n

\nThe tool has revealed HER2 expression in HER2-negative and HER2-low tumors that have been shown to benefit from targeted treatments<\/i>\n<\/p>\n

\nPaige now holds eight CE and UKCA marks in its portfolio<\/i>\n<\/p>\n

NEW YORK–(BUSINESS WIRE)–Paige<\/a>, <\/b>a global leader in clinical AI applications in pathology, today announced it received CE-IVD and UKCA marks for HER2Complete, an artificial intelligence (AI) software designed to identify patients with breast cancer whose tumors have expressions of human epidermal growth factor receptor 2 (HER2) protein.* This is the first CE-IVD and UKCA designated tool to explore the novel space of HER2-low. In a recent study, HER2Complete was able to detect levels of HER2 expression in HER2-negative (IHC-0) and HER2-low (IHC1+\/2+) hematoxylin and eosin (H&E)-stained tissue samples, the first and only AI biomarker assay capable of doing so.\n<\/p>\n

<\/a><\/p>\n

\nHER2 is a protein that promotes breast cancer cell growth, and breast cancer cells with excess levels of HER2 are called HER2-positive.1<\/sup> Targeted therapies for HER2-positive tumors have been a mainstay of cancer treatment over the past two decades. Recent evidence suggests there may be a subgroup of patients who are considered HER2-negative through standard immunohistochemistry (IHC) and fluorescence in situ<\/i> hybridization (FISH) testing but may actually have low or ultra-low levels of HER2, and therefore may be responsive to particular investigative therapies.2,3<\/sup> It has been challenging to identify these patients reliably and reproducibly using conventional methods, calling for the development of novel ways to assess a patient\u2019s HER2 status that are more accurate and sensitive than traditional assays, which were designed and optimized to detect high levels of HER2 expression.\n<\/p>\n

\nIn contrast to traditional IHC tests for HER2, Paige deploys HER2Complete to detect HER2 expression based on protein and mRNA levels on digital images of H&E-stained tissue samples, with results generated rapidly at the click of a button. Recent work has shown that HER2Complete can also identify HER2 expression in patients currently classified as IHC negative (or IHC-0), in addition to expression in HER2-low (IHC1+ and 2+\/FISH negative) patients. This approach complements existing IHC testing to potentially identify true <\/i>HER2-expressing breast cancers without the need for special staining approaches and with a very rapid turnaround using only the diagnostic biopsy or resection slides. Further, this tool has been used to detect true <\/i>HER2-negative disease, whose definitive identification based on a lack of IHC and mRNA HER2 expression may accelerate efforts for developing new therapies for this important group of patients who may not benefit from HER2 targeted therapies. This approach doesn\u2019t require any special labelling of the tissue sample and can be done rapidly and easily on standard tissue preparations using methods that already exist in labs across the globe.\n<\/p>\n

\n\u201cAI brings a transformational approach to diagnostics and allows us to identify low levels of HER2 in tissue that we would not be able to detect using current assays,\u201d said David Klimstra, M.D., Founder and Chief Medical Officer at Paige. \u201cWe are working to enable the next generation of HER2 testing to provide the information physicians need to guide the use of next generation HER2 therapy. We believe that this assay will allow us to reliably identify increased likelihood of HER2 expression, even on samples where HER2 expression was misclassified by legacy diagnostics as low or null.\u201d\n<\/p>\n

\n\u201cOur product is potentially a very targeted and cost-effective solution to identify a subset of patients who have previously been unidentified,\u201d said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. \u201cPaige is developing an end-to-end solution to detect and further characterize breast cancer so that pathologists and oncologists get comprehensive insights into an individual\u2019s cancer. We look forward to assessing the clinical utility with multiple potential partners in order to link this test to treatment outcomes.\u201d\n<\/p>\n

\n*In the United States, the software is available for Research Use Only and not for use in diagnostic procedures.<\/i>\n<\/p>\n

\nAbout Paige
\n
<\/b>Paige is using the power of AI to drive a new era of cancer discovery and treatment. To improve the lives of patients with cancer, Paige has created a cloud-based platform that transforms pathologists\u2019 workflow and increases diagnostic confidence as well as productivity, all on a global scale. Paige is the first company to receive FDA approval for a clinical AI application in digital pathology. The same Paige technology empowers pharmaceutical companies to more effectively evaluate treatment options for patients and design new biomarkers for drug development so that every patient gets precise treatment options.\n<\/p>\n

\nFor additional information, please visit: https:\/\/www.paige.ai<\/a>, Twitter<\/a> and LinkedIn<\/a>.\n<\/p>\n

\n1<\/sup> Breast Cancer HER2 Status. American Cancer Society. https:\/\/www.cancer.org\/cancer\/breast-cancer\/understanding-a-breast-cancer-diagnosis\/breast-cancer-her2-status.html<\/a>. Accessed June 9, 2022.
\n
2<\/sup> Modi S, Jacot W, Yamashita T, et al. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer [published online ahead of print, 2022 Jun 5]. N Engl J Med<\/i>. 2022;10.1056\/NEJMoa2203690. doi:10.1056\/NEJMoa2203690
\n
3<\/sup> Kolata G. Breast cancer drug trial results in ‘unheard-of’ survival. The New York Times. https:\/\/www.nytimes.com\/2022\/06\/07\/health\/enhertu-breast-cancer-chemotherapy.html<\/a>. Published June 7, 2022. Accessed June 21, 2022.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nJon Yu
\n
ICR Westwicke
\n
Tel: 475.395.5375
\n
Jon.Yu@westwicke.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Company announces CE-IVD and UKCA designations of its new digital biomarker assay, HER2Complete, to identify patients with expression of HER2 in breast cancer The tool has revealed HER2 expression in HER2-negative and HER2-low tumors that have been shown to benefit from targeted treatments Paige now holds eight CE and UKCA marks in its portfolio NEW … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-45429","format-standard","category-industry"],"yoast_head":"\nPaige Answers Call to Better Identify Breast Cancer Patients with Low Expression of HER2 - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/paige-answers-call-to-better-identify-breast-cancer-patients-with-low-expression-of-her2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Paige Answers Call to Better Identify Breast Cancer Patients with Low Expression of HER2 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Company announces CE-IVD and UKCA designations of its new digital biomarker assay, HER2Complete, to identify patients with expression of HER2 in breast cancer The tool has revealed HER2 expression in HER2-negative and HER2-low tumors that have been shown to benefit from targeted treatments Paige now holds eight CE and UKCA marks in its portfolio NEW ... 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