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  • Agendia to Highlight New MammaPrint Data at the 2016 European Breast Cancer Conference as a Prelude to Upcoming MINDACT Trial Findings | Agendia
    comparing the use of MammaPrint 70 gene assay with clinical pathological criteria current standard of care for selecting early breast cancer patients who should be treated with adjuvant chemotherapy To inquire more about the MammaPrint performance data that will be presented at EBCC please visit Agendia booth 10 602 More details about EBCC can be found on the official EBCC website The company also announced it will be hosting a lunch symposium on Saturday March 12 th entitled Updates and Competitive Assessment of Genomic Assays and Their Clinical Relevance at the upcoming Miami Breast Cancer Conference MBCC March 10 13 in Miami FL The guest speaker for the symposium is James V Pellicane Jr MD FACS who is the Director of Breast Cancer Oncology at the Bon Secours Cancer Institute in Richmond VA To inquire more about the event that will be hosted at MBCC please visit Agendia booth 15 More details about MBCC can be found on the official MBCC website About Agendia Agendia is a privately held leading molecular diagnostics company that develops and markets FFPE based genomic diagnostic products which help support physicians with their complex treatment decisions Agendia s breast cancer and colorectal cancer tests were developed using an unbiased gene selection by analyzing the complete human genome Our offerings include the FDA cleared MammaPrint FFPE as well as BluePrint a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology and TargetPrint a breast cancer ER PR HER2 expression assay These tests can help physicians assess a patient s individual risk for metastasis that is which patients are more sensitive to chemo hormonal or combination therapy and which patients may not require these treatments and which patients may be treated with other less arduous and costly methods In addition Agendia

    Original URL path: http://www.agendia.com/agendia-to-highlight-new-mammaprint-data-at-the-2016-european-breast-cancer-conference-as-a-prelude-to-upcoming-mindact-trial-findings/ (2016-05-01)
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  • Agendia Statement in Response to Recent ASCO Guidelines on Biomarker Assay Use in Adjuvant Breast Cancer Care | Agendia
    discussions In the first update to the guidelines since 2007 the authors concluded that the panel could not determine whether the assay identified a group of patients with either ER positive or negative or node positive or negative early stage breast cancer for whom chemotherapy is either not required prognosis or not effective prediction We disagree with this conclusion We feel that it s critical that all relevant information is considered in developing guidelines As part of this effort Agendia is working to finalize new analyses that further validate the use of MammaPrint in this patient population We look forward to sharing these findings as additional evidence to the added value the MammaPrint test provides physicians and their patients when considering adjuvant chemotherapy treatment For background MammaPrint is acknowledged in recently updated guidelines issued by the National Comprehensive Cancer Network NCCN These guidelines affirm that the MammaPrint test is clinically validated for prediction of prognosis of breast cancer in women of all ages and is not limited by estrogen receptor status Furthermore these guidelines cite published evidence underscoring MammaPrint s position as the only breast cancer recurrence assay supported by peer reviewed prospective outcome data MammaPrint received FDA clearance in

    Original URL path: http://www.agendia.com/agendia-statement-in-response-to-recent-asco-guidelines-on-biomarker-assay-use-in-adjuvant-breast-cancer-care/ (2016-05-01)
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  • Agendia and Partners Receive $6.8 million from European Commission to Study Targeted Therapies for Colorectal Cancer | Agendia
    advanced disease This grant recognizes the value of Agendia s ability to identify the molecular subtypes that are a central part of precision medicine to treat cancer said Mark Straley Agendia s CEO Our technology has already demonstrated the value of this approach for breast cancer said Rene Bernards Agendia s Chief Scientific Officer The MoTriColor study is expected to show that a similar therapeutic strategy can benefit colon cancer patients Including Agendia the MoTriColor project encompasses 10 institutions in the Netherlands Belgium Spain and Italy Two major pharmaceutical companies are expected to support the research Like breast cancer CRC is increasingly seen not as a single disease but rather a group of diseases with distinct molecular subtypes The MoTriColor research is particularly aimed at CRC patients with a poor prognosis Roughly 40 50 of these patients worldwide including about 40 000 European patients have one of the three molecular subtypes matched to targeted therapies in the MoTriColor project and thus could benefit from the study s results About Agendia Agendia is a privately held leading molecular diagnostics company that develops and markets FFPE based genomic diagnostic products which help support physicians with their complex treatment decisions Agendia s breast cancer and colorectal cancer tests were developed using an unbiased gene selection by analyzing the complete human genome Our offerings include the FDA cleared MammaPrint FFPE as well as BluePrint a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology and TargetPrint a breast cancer ER PR HER2 expression assay These tests can help physicians assess a patient s individual risk for metastasis that is which patients are more sensitive to chemo hormonal or combination therapy and which patients may not require these treatments and which patients may be treated with other less arduous

    Original URL path: http://www.agendia.com/agendia-and-partners-receive-6-8-million-from-european-commission-to-study-targeted-therapies-for-colorectal-cancer/ (2016-05-01)
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  • News and Press Releases | Agendia - Part 2
    Agendia Highlights Study Showing MammaPrint BluePrint Tests Predict Response to Current Breast Cancer Chemotherapy and Targeted Therapy Regimens 09 29 2015 Researchers Present Data at Breast Cancer Symposium Showing MammaPrint BluePrint Can Identify Women Who Benefit from Chemotherapy and Targeted Dual Anti HER2 Drug Treatment Before Surgery IRVINE CA and AMSTERDAM THE NETHERLANDS Agendia s MammaPrint and BluePrint tests provide new insights that may provide many Continued Agendia Board of Directors Appoints Mark R Straley as New Chief Executive Officer 09 28 2015 IRVINE CA and AMSTERDAM Agendia Inc a world leader in personalized medicine and molecular cancer diagnostics today announced the appointment of veteran diagnostics industry leader Mark R Straley as Chief Executive Officer He succeeds Jan Egberts M D who took Continued NCCN Breast Cancer Guidelines Acknowledge MammaPrint s Ability to Predict Prognosis 07 28 2015 Respected Panel Cites RASTER the Only Published Prospective Outcome Data of Its Kind Which Demonstrates MammaPrint s Ability to Identify Those Patients Who May Safely Forego Chemotherapy IRVINE CA and AMSTERDAM THE NETHERLANDS Agendia a global molecular diagnostics company that Continued Agendia Announces Recommendation of MammaPrint in Germany s AGO Guidelines at St Gallen International Breast Cancer Conference 04 07 2015 Company

    Original URL path: http://www.agendia.com/agendia-news-and-press-releases/page/2/ (2016-05-01)
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  • Molecular subtyping improves stratification of patients into diagnostically more meaningful risk groups | Agendia
    diagnostically more meaningful risk groups Publication Name Cancer Research Author s Massimo Cristofanilli Karen Kaul Mary Turk JoEllen Weaver Jelle Wesseling Lisette Stork Sloots Femke de Snoo Katharine Yao December 1 2013 This retrospective study showed that Molecular Subtyping of early breast cancers using Mammaprint and BluePrint leads to reclassification of 25 51 208 of tumors with potential therapeutic and prognostic implications 39 of clinical HER 2 disease should have been treated with therapies for Luminal type disease e g endocrine therapy 20 of clinical triple negative disease could have been treated with therapies for Luminal and HER2 type disease endocrine therapy and trastuzumab based regimens The use of Mammaprint and BluePrint should be implemented in the management of primary breast cancer for the selection of adjuvant therapy in this era of personalized care Those diagnostic platforms allow precision medicine by accurately predicting the molecular phenotype of the disease See Poster Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5 Cost Effectiveness 6 Development 8 Impact Study 2 MammaPrint 40 MINDACT 5 News 56 Predictive 3 Press Release 53 Publications 58 Review Article 10 St Gallen Guidelines 2 TargetPrint 4 Treatment Impacts 5 Validation 18 Video

    Original URL path: http://www.agendia.com/molecular-subtyping-improves-stratification-of-patients-into-diagnostically-more-meaningful-risk-groups/ (2016-05-01)
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  • High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial. | Agendia
    FA Stork Sloots L Russo L Dell Orto P van den Akker J Glas A Cardoso F TRANSBIG Consortium the MINDACT Investigators April 21 2014 BACKGROUND To investigate the correlation of TargetPrint with local and central immunohistochemistry fluorescence in situ hybridization assessment of estrogen ER progesterone PgR and human epidermal growth factor receptor 2 HER2 in the first 800 patients enrolled in the MINDACT trial PATIENTS AND METHODS Data from local N 800 and central N 626 assessments of receptor status were collected and compared with TargetPrint results RESULTS For ER the positive agreement the percentage of central pathology positive assessments that were also TargetPrint local laboratory positive for TargetPrint in comparison to centralized assessment was 98 with a negative agreement the percentage of central pathology negative assessments that were also TargetPrint local laboratory negative of 96 For PgR the positive agreement was 83 with a negative agreement of 92 For HER2 the positive agreement was 75 with a negative agreement of 99 Even though the local assessment showed higher positive agreement for PgR 89 and higher positive agreement for HER2 85 the range of discordant local versus central assessments were as high as 6 7 for ER 12 9 for PgR and 4 3 for HER2 CONCLUSION TargetPrint and local assessment of ER PgR and HER2 show high concordance with central assessment in the first 800 MINDACT patients However there are concerns about the higher discordance rates for some local sites TargetPrint can improve the reliability of hormone receptor and HER2 testing for those centers with a lower rate of concordance with the reference laboratory with the limitation of a positive agreement of 75 for HER2 TargetPrint consequently has important implications for treatment decisions in clinical practice and is a reliable alternative to local assessment for ER See Article

    Original URL path: http://www.agendia.com/high-concordance-of-protein-by-ihc-gene-by-fish-her2-only-and-microarray-readout-by-targetprint-of-er-pgr-and-her2-results-from-the-eortc-10041big-03-04-mindact-trial/ (2016-05-01)
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  • PROMIS – PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score | Agendia
    MammaPrint BluePrint and TargetPrint in women with an intermediate Oncotype DX score An initial CRF capturing baseline patient characteristics pathology information Oncotype DX score and the recommended treatment plan will be completed before receiving the MammaPrint result A second CRF capturing the actual treatment will be completed within 4 weeks after receiving the MammaPrint result See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5

    Original URL path: http://www.agendia.com/prospective-study-of-mammaprint-in-breast-cancer-patients-with-an-intermediate-recurrence-score-promis/ (2016-05-01)
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  • MINT I – Multi-Institutional Neoadjuvant Therapy, MammaPrint Project I | Agendia
    chemotherapy measures the in vivo response to chemotherapy 1 assesses long term clinical outcomes associated with that response2 3 and enables some patients to undergo breast conservation therapy due to therapeutic down staging of the tumor In the current study the chemosensitivity predictiveness of MammaPrint and BluePrint will be assessed in patients receiving neoadjuvant chemotherapy in the clinical diagnostic setting See Poster Categories Abstract Poster 18 Accreditation 1 BluePrint 9

    Original URL path: http://www.agendia.com/mint-i-multi-institutional-neoadjuvant-therapy-mammaprint-project-i-2/ (2016-05-01)
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