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  • 2014 | Agendia
    IHC fluorescence in situ hybridization FISH subtyping to predict chemosensitivity as defined by pathological complete response pCR or endocrine sensitivity as defined by partial response Continued Agendia Breast Cancer Test for Molecular Subtyping Improves Match of Therapy to Patient Study Finds Publication Name Press Release October 9 2014 IRVINE CA and AMSTERDAM New data from an ongoing study indicates the BluePrint genomic test provides information about the molecular subtype of breast cancer that adds value beyond what can be learned from conventional IHC FISH pathology testing The results were reported at Continued Agendia Board of Directors Appoints Jan Egberts M D as CEO Publication Name Press Release October 2 2014 IRVINE CA and AMSTERDAM Agendia Inc a leading molecular diagnostic company today announced the appointment of life science industry veteran and Agendia board member Jan H Egberts M D as CEO He replaces David Macdonald who has left the company Continued Agendia Test for Molecular Subtyping of Breast Cancer Is a Better Guide to Pre Surgical Treatment Study Finds Author s Press Release September 17 2014 IRVINE CA and AMSTERDAM In findings that could eventually change the way breast cancer is treated a study reports that the BluePrint genomic test provides more accurate information about the molecular subtype of breast cancer than does conventional IHC FISH Continued Agendia Announces Study Showing Molecular Subtyping Can Improve Breast Cancer Treatment Publication Name Press Release September 2 2014 IRVINE CA and AMSTERDAM In findings that may eventually change the way breast cancer is evaluated and treated a new study reports that the BluePrint genomic test provides more accurate information about the molecular subtype of a specific breast Continued Agendia Co Founder and CSO Develops Method to Identify Women Who Will Benefit from Tamoxifen Therapy for Breast Cancer Publication Name Press Release July 31

    Original URL path: http://www.agendia.com/2014/ (2016-05-01)
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  • 2013 | Agendia
    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 Continued Performance Characteristics of the MammaPrint Breast Cancer Diagnostic Gene Signature Publication Name Personalized Medicine Author s Leonie JM Delahaye Diederik Wehkamp Arno N Floore Rene Bernards Laura J van t Veer1 Annuska M Glas November 1 2013 The analytical performance of multigene signatures depends on many parameters including precision repeatability reproducibility and intratumor heterogeneity Indicators such as sensitivity specificity positive predictive value and negative predictive value are typically used to define the clinical performance of a diagnostic Continued Multiple International Breast Cancer Guidelines Confirm Use of Agendia Tests for Prognostic Predictive Information in Cancer Treatment Decisions Publication Name Press Release September 19 2013 Important Role of Molecular Subtyping in Determining the Need for Chemotherapy also Cited IRVINE CA and AMSTERDAM THE NETHERLANDS September 9 2013 Agendia a leader in molecular cancer diagnostics today announced that multiple established international breast cancer treatment guidelines Continued Researchers Identify Splice Variant of Breast Cancer Gene that Can Mask Risk of Recurrence Publication Name Press Release August 27 2013 High Risk Patients with Unusual Hormone Receptors May Be Undertreated IRVINE CA and AMSTERDAM THE NETHERLANDS August 27 2013 Agendia a leader in molecular cancer diagnostics announced today that researchers have identified a subset of breast cancer patients whose Continued Estrogen receptor splice variants as a potential source of false positive estrogen receptor status in breast cancer diagnostics Publication Name Breast Cancer Research and Treatment Author s Groenendijk Wilbert Zwart

    Original URL path: http://www.agendia.com/2013/ (2016-05-01)
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  • 2012 | Agendia
    Release December 7 2012 SAN ANTONIO The latest generation of genomic tests for breast cancer can improve physicians ability to diagnose the disease and more precisely tailor each patient s treatment according to a study being presented at the 2012 CTRC AACR San Antonio Breast Cancer Symposium Continued Cost Effectiveness of Gene Expression Profiling for Early Stage Breast Cancer Publication Name Cancer Author s Mo Yang MS Suja Rajan PhD and Amalia M Issa PhD MPH December 6 2012 BACKGROUND Gene expression profiling GEP is being used increasingly for risk stratification to identify women with lymph nodenegative estrogen receptor positive early stage breast cancer who are most likely to benefit from adjuvant chemotherapy The authors of this report evaluated the Continued 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 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 Continued Agendia Announces Five Studies in Breast Cancer for Presentation at the American Society of Clinical Oncology 2012 Breast Cancer Symposium Publication Name Press Release September 13 2012 AMSTERDAM THE NETHERLANDS and IRVINE CA September 13 2012 Agendia an innovative molecular cancer diagnostics company and leader in personalized medicine announced today that they will present five posters on genomic research studies in breast cancer at the American Society of

    Original URL path: http://www.agendia.com/2012/ (2016-05-01)
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  • 2011 | Agendia
    In Node negative and 1 3 node positive Disease may Avoid ChemoTherapy trial investigates the clinical utility of the 70 gene profile MammaPrint for the selection of breast cancer patients for adjuvant chemotherapy CT together with standard clinicopathological criteria Continued Head to head comparison of the 70 gene signature versus the 21 gene assay cost effectiveness and the effect of compliance Publication Name Breast Cancer Research and Treatment Author s Valesca P Retel Manuela A Joore Wim H van Harten September 2 2011 Both the 70 gene signature and the 21 gene assay are novel prognostic tests used to guide adjuvant chemotherapy decisions in patients with early breast cancer Although the results of ongoing prospective trials will only become available in some years the tests Continued First generation prognostic gene signatures for breast cancer predict both survival and chemotherapy sensitivity and identify overlapping patient populations Publication Name Breast Cancer Res Treat Author s Takayuki Iwamoto Ju Seog Lee Giampaolo Bianchini Rebekah E Hubbard July 27 2011 The aims of this study were to compare the performance of six different genomic prognostic markers to predict long term survival and chemotherapy response on the same patient cohort and assess if clinicopathological variables carry independent prognostic and predictive values We Continued A diagnostic gene profile for molecular subtyping of breast cancer associated with treatment response Publication Name Breast Cancer Research and Treatment Author s Oscar Krijgsman Paul Roepman Wilbert Zwart Jason S Carroll Sun Tian Femke A de Snoo Richard A Bender Rene Bernards Annuska M Glas July 13 2011 Classification of breast cancer into molecular subtypes maybe important for the proper selection of therapy as tumors with seemingly similar histopathological features can have strikingly different clinical outcomes Herein we report the development of a molecular subtyping profile BluePrint that Continued A gene profile that identifies molecular subtypes of breast cancer is highly enriched in genes having 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 Continued The PARSC Trial a Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint Publication Name ASCO 2011 Poster Author s R Salazar R Rosenberg M Lutke Holzik J Marshall4 J J M Van Der Hoeven B Glimelius F Bibeau L Stork Sloots June 4 2011 Background An 18 gene expression profile ColoPrint has been developed for identifying CC patients more likely to develop recurrent disease and who would be candidates for adjuvant chemotherapy The gene signature was validated in in silico datasets and independent patient cohorts of stage Continued Strategies for subtypes dealing with the diversity of breast cancer highlights of the St Gallen International Expert Consensus on the Primary

    Original URL path: http://www.agendia.com/2011/ (2016-05-01)
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  • 2010 | Agendia
    expression of 70 genes To better understand the tumor biology assessed by MammaPrint we interpreted the biological functions of the 70 genes and showed Continued Gene Expression Signature to Improve Prognosis Prediction of Stage II and III Colorectal Cancer Publication Name Journal of Clinical Oncology Author s Ramon Salazar Paul Roepman Gabriel Capella Victor Moreno Iris Simon Christa Dreezen Adriana Lopez Doriga Cristina Santos Corrie Marijnen Johan Westerga Sjoerd Bruin David Kerr Peter Kuppen Cornelis van de Velde Hans Morreau Loes Van Velthuy November 23 2010 Purpose This study aims to develop a robust gene expression classifier that can predict disease relapse in patients with early stage colorectal cancer CRC Patients and Methods Fresh frozen tumor tissue from 188 patients with stage I to IV CRC undergoing Continued Identification of a low risk subgroup of HER 2 positive breast cancer by the 70 gene prognosis signature Publication Name British Journal of Cancer Author s M Knauer F Cardoso J Wesseling PL Bedard SC Linn EJT Rutgers and LJ van t Veer September 20 2010 BACKGROUND Overexpression of HER 2 is observed in 15 25 of breast cancers and is associated with increased risk of recurrence Current guidelines recommend trastuzumab and chemotherapy for most HER 2 positive patients However the majority of patients does not recur and might thus Continued Comparison of MammaPrint and TargetPrint results with clinical parameters in German patients with early stage breast cancer Publication Name International Journal of Molecular Medicine Author s Heidrun Gevensleben Uwe Jochen Gohring Reinhard Buttner Lukas C Heukamp Georg Kunz Thomas Dimpfl Christian Jackisch Olaf Ortmann Ute Susann Albert Richard Bender Femke De Snoo Oscar Krijgsman Annuska M Glas July 30 2010 The 70 gene expression profile MammaPrint is a powerful prognostic indicator for disease outcome in breast cancer patients with improved prediction of recurrence risk compared to currently used guidelines The microarray based test TargetPrint further provides reliable quantitative assessment of mRNA expression Continued Gene Signatures as predictors of response to neoadjuvant chemotherapy with docetaxel doxorubicin cyclophosphamide TAC or AC and nab paclitaxel and carboplatin trastuzumab in patients with stage II III and inflammatory breast cancer Publication Name ASCO Poster 2010 Author s G Somlo P H Frankel L Vora S Lau T H Luu L Kruper J Yim Y Yen F de Snoo R A Bender June 7 2010 Pathologic complete response pCR and residual cancer burden RCB scores of 0 pCR and 1 near CR after NCT predict for better survival Symmans et al J Clin Oncol 25 4414 22 2007 Improved NCTs and molecular markers predicting for response are Continued Agendia Presents Broad Array of Predictive and Prognostic Studies on Breast and Colorectal Cancers at ASCO 2010 Annual Meeting Publication Name Press Release June 4 2010 HUNTINGTON BEACH CA and AMSTERDAM THE NETHERLANDS June 4 2010 Agendia a world leader in molecular cancer diagnostics today announced that researchers from Agendia and leading academic centers in the U S and Europe will present data from multiple studies concerning Continued Clinical

    Original URL path: http://www.agendia.com/2010/ (2016-05-01)
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  • 2009 | Agendia
    gene profile for classification of breast cancer J Clin Oncol 2009 27 15s December 31 2009 Background Classification of breast cancers into molecular subtypes may be important for accurate selection of therapy for patients Herein we report a multigene profile for classification of breast cancer into molecular subtypes The profile separates tumors into hormone receptor HR luminal like HER2 ERBB2 like Continued Microarray Based Determination of Estrogen Receptor Progesterone Receptor and HER2 Receptor Status in Breast Cancer Publication Name Clinical Cancer Research Author s Paul Roepman Hugo M Horlings Oscar Krijgsman Marleen Kok Jolien M Bueno de Mesquita Richard Bender Sabine C Linn Annuska M Glas and Marc J van de Vijver November 3 2009 Purpose The level of estrogen receptor ER progesterone receptor PR and HER2 aids in the determination of prognosis and treatment of breast cancer Immunohistochemistry is currently the predominant method for assessment but differences in methods and interpretation can substantially affect Continued The 70 gene prognosis signature predicts early metastasis in breast cancer patients between 55 and 70 years of age Publication Name Annals of Oncology Author s Mook S Schmidt MK Weigelt B October 21 2009 Background The majority of breast cancer patients are postmenopausal women who are increasingly being offered adjuvant chemotherapy Since the beneficial effect of chemotherapy in postmenopausal patients predominantly occurs in the first 5 years after diagnosis a prognostic marker for early Continued Validation of 70 gene prognosis signature in node negative breast cancer Publication Name Breast Cancer Research Treatment Author s Bueno de Mesquita JM Keijzer R Linn SC October 1 2009 Purpose The 70 gene prognosis signature van t Veer et al Nature 415 6871 530 536 2002 may improve the selection of lymph node negative breast cancer patients for adjuvant systemic therapy Optimal validation of prognostic classifiers is of great importance and we therefore wished to Continued Gene expression profiling in breast cancer design of a pooled database to address open questions Publication Name European Surgery Author s Michaël Knauer Etienne Wenzl Emiel J Rutgers Sabine C Linn Laura J van t Veer September 7 2009 BACKGROUND The Netherlands Cancer Institute used DNA microarray analyses to identify a 70 gene expression profile strongly predictive of a short interval to distant metastases in breast cancer For patients with small tumors the signature is not yet adequately validated Furthermore Continued The 70 gene prognosis profile predicts disease outcome in breast cancer patients with 1 3 positive lymph nodes in an independent validation study Publication Name Breast Cancer Research and Treatment Author s Mook S Schmidt M S Viale G July 27 2009 Purpose The 70 gene prognosis signature has shown to be a valid prognostic tool in node negative breast cancer Although axillary lymph node status is considered to be one of the most important prognostic factors still 25 30 of node positive breast cancer patients will Continued Thresholds for therapies highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer Publication Name Annals

    Original URL path: http://www.agendia.com/2009/ (2016-05-01)
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  • Agendia’s MammaPrint® First and Only Genomic Assay to Receive Level 1A Clinical Utility Evidence for Chemotherapy Benefit in Early Breast Cancer Patients | Agendia
    cancer patient The MINDACT trial is the first prospective randomized controlled clinical trial of a breast cancer recurrence genomic assay with level 1A clinical evidence and the first prospective translational research study of this magnitude in breast cancer to report the results of its primary objective Among the 3 356 patients enrolled in the MINDACT trial who were categorized as having a high risk of breast cancer recurrence based on common clinical and pathological criteria C high the MammaPrint assay reduced the chemotherapy treatment prescription by 46 percent Using the 70 gene assay MammaPrint 48 percent of lymph node positive breast cancer patients considered clinically high risk Clinical high and genomic low risk MammaPrint low had an excellent distant metastasis free survival at five years in excess of 94 percent Traditionally physicians have relied on clinical pathological factors such as age tumor size tumor grade lymph node involvement and hormone receptor status to make breast cancer treatment decisions said Massimo Cristofanilli MD Associate Director of Translational Research and Precision Medicine at the Robert H Lurie Comprehensive Cancer Center Northwestern University in Chicago These findings provide level 1A clinical utility evidence by demonstrating that the detection of low risk of distant recurrence reported by the MammaPrint test can be safely used in the management of thousands of women by identifying those who can be spared from a toxic and unnecessary treatment MINDACT is a randomized phase III trial that investigates the clinical utility of MammaPrint when compared or used in conjunction with to the standard clinical pathological criteria for the selection of patients unlikely to benefit from adjuvant chemotherapy From 2007 to 2011 6 693 women who had undergone surgery for early stage breast cancer enrolled in the trial 111 centers in nine countries Participants were categorized as low or high risk for tumor recurrence in two ways first through analysis of tumor tissue using MammaPrint at a central location in Amsterdam and second using Adjuvant Online a tool that calculates risk of breast cancer recurrence based on common clinical and biological criteria Patients characterized in both clinical and genomic assessments as low risk are spared chemotherapy while patients characterized as high risk are advised chemotherapy Those with conflicting results are randomized to use either clinical or genomic risk MammaPrint evaluation to decide on chemotherapy treatment The MINDACT trial is managed and sponsored by the EORTC as part of an extensive and complex partnership in collaboration with Agendia and BIG and many other academic and commercial partners as well as patient advocates These MINDACT trial results are a testament that the science of the MammaPrint test is the most robust in the genomic breast recurrence assay market Agendia will continue to collaborate with pharmaceutical companies leading cancer centers and academic groups on additional clinical research and in the pursuit of bringing more effective individualized treatments within reach of cancer patients said Mark Straley Chief Executive Officer at Agendia We value the partnership with the EORTC and BIG and it s a

    Original URL path: http://www.agendia.com/agendias-mammaprint-first-and-only-genomic-assay-to-receive-level-1a-clinical-utility-evidence-for-chemotherapy-benefit-in-early-breast-cancer-patients/ (2016-05-01)
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  • MINDACT results will be presented at AACR 2016 | Agendia
    study a prospective randomised study evaluating the clinical utility of the 70 gene signature MammaPrint combined with common clinical pathological criteria for selection of patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes will be presented during the AACR Annual Meeting 2016 16 20 April New Orleans Louisiana USA www aacr org MINDACT is the first prospective randomised controlled clinical trial of a breast cancer recurrence genomic assay with Level 1A clinical evidence It is also the first prospective translational research study of this magnitude in breast cancer to report the results of its primary objective AACR has identified MINDACT as newsworthy and will include it in the conference s official media relations programme On Monday April 18 a press conference is scheduled at 8 30 am CDT during which Professor Martine Piccart one of the three principal investigators of MINDACT as well as Professor Laura van t Veer Leading Scientist and developer of the 70 gene signature will be available to answer questions about the trial design and the potential importance of its results The actual presentation of MINDACT results will be made by Professor Piccart in the Clinical Trials Plenary Session taking place soon thereafter Session Title Transformative Clinical Trials in Breast Cancer Session Start Time Monday April 18 2016 10 30 AM Session End Time Monday April 18 2016 12 30 PM Location La Nouvelle Orleans Ballroom Morial Convention Center CME Status CME Designated Session Please visit http www abstractsonline com or the online Itinerary Planner for the exact time of this presentation Once MINDACT study results have been made public EORTC BIG and Agendia will communicate them on their websites For more information please visit eortc org BIGagainstbreastcancer org www agendia com Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies

    Original URL path: http://www.agendia.com/mindact-results-will-be-presented-during-the-aacr-annual-meeting-2016/ (2016-05-01)
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