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  • Gene expression profiling to predict the risk of locoregional recurrence in breast cancer | Agendia
    to predict the risk of locoregional recurrence in breast cancer Publication Name Cancer Research Author s C A Drukker M V Nijenhuis S G Elias J Wesseling N S Russell P Whitworth R Patel F de Snoo L J van t Veer P D Beitsch E J Th Rutgers December 15 2012 The 70 gene signature is able to predict the risk of locoregional recurrence We observed a significantly lower incidence of locoregional recurrence in patients with a low risk 70 gene signature result compared to those with high risk 70 gene signature result independent of known risk factors Patients with high risk 70 gene signature cancers are eligible for extensive adjuvant treatment radiotherapy chemotherapy and or endocrine therapy to reduce the risk of distant as well as locoregional recurrence Patients with low risk 70 gene signature cancers are eligible for more limited local treatment strategies 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 3 Physician Education

    Original URL path: http://www.agendia.com/gene-expression-profiling-to-predict-the-risk-of-locoregional-recurrence-in-breast-cancer/ (2016-05-01)
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  • Comparison of molecular (BluePrint+MammaPrint) and pathological subtypes for breast cancer among the first 800 patients from the EORTC 10041/BIG 3-04 (MINDACT) trial | Agendia
    MammaPrint and pathological subtypes for breast cancer among the first 800 patients from the EORTC 10041 BIG 3 04 MINDACT trial Publication Name SABCS 2012 Poster Author s Giuseppe Viale Leen Slaets Femke de Snoo Laura J van t Veer Emiel J Rutgers Martine Piccart Jan Bogaerts Jeroen van den Akker Lisette Stork Sloots Kristel Engelen Leila Russo Patrizia Dell Orto Fatima Cardoso December 6 2012 Biology has become the main driver of breast cancer therapy Intrinsic biological subtypes by gene expression profiling have been identified Pathology can be used to define surrogates of these subtypes but these are not always concordant which may lead to different treatment plans We investigated the concordance between BluePrint MammaPrint micro array based breast cancer subtypes and pathological surrogates based on ER PR HER2 Ki67 Contrary to the Perou gene set evolved into PAM50 BluePrint was trained using pathological data 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 3 Physician Education

    Original URL path: http://www.agendia.com/comparison-of-molecular-blueprintmammaprint-and-pathological-subtypes-for-breast-cancer-among-the-first-800-patients-from-the-eortc-10041big-3-04-mindact-trial/ (2016-05-01)
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  • Response to neo-adjuvant chemotherapy and outcomes for I-SPY 1 patients stratified by the 70-gene prognosis signature (MammaPrint) and molecular subtyping (BluePrint) | Agendia
    70 gene prognosis signature MammaPrint and molecular subtyping BluePrint Publication Name Cancer Research Poster Author s Stefan Glück Femke de Snoo Sun Tian Annuska Glas Laura van t Veer December 15 2011 Classification of breast cancers into molecular subtypes may be important for the proper selection of therapy for patients as tumors with seemingly similar biology can have strikingly different clinical outcomes The multi center neo adjuvant I SPY 1 TRIAL CALGB 150007 150012 ACRIN 6657 showed that breast cancer subtypes as identified by immunohistochemistry or molecular analyses have distinct clinical outcome1 Table 1 and 2 The median follow up period of the trial is 3 9 years Here we present how the 70 gene signature MammaPrint now analyzed together with an 80 gene molecular subtyping profile2 BluePrint Basal type Luminal type HER2 type stratifies patients into molecular subgroups and show the relation to response to neo adjuvant chemotherapy and survival for the I SPY I patients 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

    Original URL path: http://www.agendia.com/response-to-neo-adjuvant-chemotherapy-and-outcomes-for-i-spy-1-patients-stratified-by-the-70-gene-prognosis-signature-mammaprint-and-molecular-subtyping-blueprint/ (2016-05-01)
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  • A gene profile that identifies molecular subtypes of breast cancer is highly enriched in genes having Estrogen Receptor binding sites | Agendia
    Estrogen Receptor binding sites Publication Name ASCO 2011 Poster Author s W Zwart F De Snoo et al June 6 2011 Classification of breast cancer into molecular subtypes may be important for the proper selection of therapy as tumors with seemingly similar biology can have strikingly different clinical outcomes We have previously developed an 80 gene molecular subtyping profile BluePrint for the classification of breast cancer into three molecular subtypes triplenegative Basal type hormone receptor positive Luminal type and ERBB2 positive ERBB2 type In this study we sought to determine if Luminal type tumors are characterized by active ER signaling Conclusions Luminal type associated genes are enriched for ER binding sites proximal to the transcription start site suggesting that these genes are direct targets of ER Classification of breast tumors as Luminal by BluePrint most likely describes breast cancers that depend of ER signaling This data suggests that Luminal type breast cancer are likely to response to endocrine therapy 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

    Original URL path: http://www.agendia.com/a-gene-profile-that-identifies-molecular-subtypes-of-breast-cancer-is-highly-enriched-in-genes-having-estrogen-receptor-binding-sites/ (2016-05-01)
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  • Agendia Earns ISO Certification for Facilities in Amsterdam and Irvine | Agendia
    confirms that the execution of Agendia s Symphony diagnostic services including MammaPrint BluePrint TargetPrint and TheraPrint meet the highest internationally recognized quality standards In addition the certification affirms that the design and development of all of Agendia s current and future diagnostic services are of the highest quality Agendia is committed to developing clinically useful diagnostic tests that provide clear and accurate results Part of this commitment is ensuring that our products and facilities comply with the most rigorous quality standards said David Macdonald CEO of Agendia In addition to the FDA clearances for our products ISO certification provides patients and physicians with the confidence that Agendia s diagnostic tests provide safe effective reliable and actionable information The ISO 13485 quality standard specifies requirements for a quality management system to demonstrate its ability to consistently meet customer and regulatory requirements The primary objective of ISO 13485 is to harmonize regulatory requirements for quality management systems globally and includes an emphasis on process control and effectiveness for design development manufacture risk management and distribution of related medical services About Agendia Agendia is a leading molecular diagnostic company that develops and markets genomic based diagnostic products which help support physicians with their complex treatment decisions Agendia s breast cancer Symphony suite was developed using unbiased gene selection analyzing the complete human genome ensuring 100 definitive results for cancer patients Symphony includes MammaPrint the first and only FDA cleared IVDMIA breast cancer recurrence assay as well as BluePrint a molecular subtyping assay TargetPrint an ER PR HER2 expression assay and TheraPrint an alternative therapy selection assay Together these tests help physicians determine a patient s individual risk for metastasis which patients will benefit from chemo hormonal or combination therapy and which patients do not require these treatments and can instead be treated with

    Original URL path: http://www.agendia.com/agendia-earns-iso-certification-for-facilities-in-amsterdam-and-irvine/ (2016-05-01)
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  • Combining multigene profiling of molecular subtypes with the 70-gene profile for classification of breast cancer | Agendia
    multigene profile for classification of breast cancer into molecular subtypes The profile separates tumors into hormone receptor HR luminal like HER2 ERBB2 like and triple negative basal like subclasses Methods A multi gene profile was developed based on a series of 200 tumor samples of known ER PR and HER2 receptor status concordant IHC and gene expression result hybridized on 44k microarrays The profile classifies 96 concordant to the molecular subtypes named luminal ERBB2 or basal type as published by Perou et al Perou et al Nature 2000 Fan et al NEJM 2005 The profile was validated using 469 independent samples as well as on two publically available gene expression datasets n 251 and n 159 Results The profile classified 66 712 as luminal like 18 194 ERBB2 like and 16 173 as basal like As compared to single marker readout for the presence of ER PR and HER2 13 of the samples that were scored positive for presence of ER PR did not express a luminal like gene profile Samples with a ERBB2 like or basal like gene profile showed equally poor 5 year survival rates of 65 However the ERBB2 like subset of MammaPrint low risk patients 15 showed an 89 95 CI 71 100 survival rate without trastuzumab treatment When the luminal like subtype was separated into high and low risk by MammaPrint the survival rate was 56 95 CI 46 68 for high risk luminal like samples and 94 95 CI 90 99 for low risk samples Conclusions The developed multigene profile can classify breast tumors into luminal ERBB2 and basal like subgroups By combining this molecular subtyping with MammaPrint risk classification specific groups of patients can be recognized that that are at high risk of recurrence The low risk patients within the luminal and ERBB2

    Original URL path: http://www.agendia.com/combining-multigene-profiling-of-molecular-subtypes-with-the-70-gene-profile-for-classification-of-breast-cancer/ (2016-05-01)
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  • NBRST – Prospective neo-adjuvant registry trial linking MammaPrint, subtyping and treatment response: Neoadjuvant Breast Registry – Symphony Trial | Agendia
    Search for Search More Publications NBRST Prospective neo adjuvant registry trial linking MammaPrint subtyping and treatment response Neoadjuvant Breast Registry Symphony Trial Publication Name Cancer Research Author s Pat Whitworth Mark Gittleman Stephanie Akbari Bichlien Nguyen Paul Baron Michael Rotkiss Jennifer Beatty Jessica Gibson Lisette Stork Sloots Femke de Snoo Peter Beitsch December 15 2011 The scope of this registry study is to measure chemosensitivity as defined by pCR primary endpoint or endocrine sensitivity as defined by partial response decrease in longest tumor diameter or residual cancer burden category 1 RCB1 a primary endpoint for neo adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy metastasis free survival and relapse free survival secondary endpoints in molecular subgroups determined by the established MammaPrint BluePrint Targetprint and Theraprint profiles in addition to possible novel expression profiles See more at clinicaltrials gov 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 3 Physician Education Breast Cancer Colon Cancer Publications Client Login Ordering

    Original URL path: http://www.agendia.com/prospective-neo-adjuvant-registry-trial-linking-mammaprint-subtyping-and-treatment-response-neoadjuvant-breast-registry-symphony-trial-nbrst/ (2016-05-01)
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  • The PARSC Trial, a Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint | Agendia
    for adjuvant chemotherapy The gene signature was validated in in silico datasets and independent patient cohorts of stage II and III patients Uni and multivariate analysis was performed on the pooled stage II patient set n 320 who had a median follow up of 70 months ColoPrint identified two third of the stage II patients 209 320 as low risk The 3 year relapse free survival was 94 for Low Risk patients and 79 for High Risk patients with a HR of 2 74 95 CI 1 54 4 88 p 0 006 Moreover the profile stratified patients independent of ASCO clinical risk factors Methods A prospective trial PARSC Prospective study for the Assessment of Recurrence risk in Stage II CC patients using ColoPrint has been initiated Objectives are 1 to validate the performance of ColoPrint in estimating the 3 year relapse rate in patients with stage II colon cancer 2 to compare the risk assessment in stage II patients using the ColoPrint profile vs a clinical risk assessment based on Investigator s assessment of risk and ASCO high risk recommendations 3 to investigate therapy as a potential confounding factor for ColoPrint results and 4 to assess the performance of ColoPrint in estimating the 3 year relapse rate in patients with stage III colon cancer Inclusion criteria age 18 years adenocarcinoma of the colon stage II and III no prior neo adjuvant therapy no synchronous tumors fresh tumor sample and written informed consent The treatment of the patient is at the discretion of the physician adhering to National Comprehensive Cancer Network NCCN approved regimens or a recognized alternative Results The trial started in Sept 2008 with currently 30 participating sites in 11 countries Thus far 288 eligible stage 2 and 251 stage 3 patients have been enrolled Conclusions The aim

    Original URL path: http://www.agendia.com/the-parsc-trial-a-prospective-study-for-the-assessment-of-recurrence-risk-in-stage-ii-colon-cancer-patients-using-coloprint/ (2016-05-01)
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