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  • Agendia | Agendia
    Clinical Classification In the clinical High Risk group 32 more patients could have been able to safely forgo chemotherapy if they were treated according to MammaPrint results We strive to improve the quality of life for cancer patients through molecular diagnostics one patient at a time view publications What Can We Do For You healthcare professionals Patients Agendia is a leader in the precision medicine era bringing more effective individualized treatment within reach of cancer patients Leveraging the latest advancements in cancer research Agendia s suite of tests are designed to help physicians more accurately individualize and optimize cancer therapy Learn More If you ve recently been diagnosed with breast cancer it s natural to have questions and concerns The Patient section of this web site has been specifically designed to help you learn more about breast cancer and Agendia s innovative genomic tests that uncover more clinically actionable biology Our testing can provide you and your doctor with a detailed profile of your unique tumor to help make more informed treatment decisions Learn More MammaPrint is the ONLY breast cancer recurrence assay backed by peer reviewed PROSPECTIVE outcome data 1 With NO Intermediate results 2 MammaPrint gives you up to 39 MORE DEFINITIVE results 3 Publications Breast Cancer News Press available worldwide Contact us Adam Brufsky M D Dr Adam Brufsky discusses a study comparing MammaPrint to the 21 gene assay and how BluePrint molecular subtyping compares to traditional subtyping Adam Brufsky M D Dr Adam Brufsky discusses a study comparing MammaPrint to the 21 gene assay and how BluePrint molecular subtyping compares to traditional subtyping Share This Video http www youtube com watch v u2pzHLBHYns Massimo Cristofanilli M D Dr Massimo Cristofanilli discusses the benefits of using the MammaPrint 70 Gene assay and the BluePrint 80 Gene assay

    Original URL path: http://www.agendia.com/ (2016-05-01)
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  • International | Agendia
    for Search More International Agendia International Please select a country below to see our international websites Australia Denmark Germany Italy Netherlands New Zealand Norway Sweden Turkey United Kingdom We d Love To Hear From You Name Email Questions Comments Concerns Questions Comments Concerns Comments This field is for validation purposes and should be left unchanged Resources Online Ordering Publications Studies Physician Education Breast Cancer Colon Cancer Publications Client Login Ordering

    Original URL path: http://www.agendia.com/international/ (2016-05-01)
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  • Publications | Agendia
    2011 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 Read More Strategies for subtypes dealing with the diversity of breast cancer highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011 Publication Name Annals of Oncology May 23 2011 Author s A Goldhirsch W C Wood A S Coates R D Gelber B Thu rlimann H J Senn Panel Read More Gene Expression Profiles from Formalin Fixed Paraffin Embedded Breast Cancer Tissue Are Largely Comparable to Fresh Frozen Matched Tissue Publication Name PLOS ONE February 1 2011 Author s Lorenza Mittempergher Jorma J de Ronde Marja Nieuwland Ron M Kerkhoven Iris Simon Emiel J Th Rutgers Lodewyk F A Wessels Laura J Van t Veer Read More TSPYL5 suppresses p53 levels and function by physical interaction with USP7 Publication Name Nature Cell Biology December 19 2010 Author s Mirjam T Epping Lars A T Meijer Oscar Krijgsman Johannes L Bos Pier Paolo Pandolfi and René Bernards Read More Cost Effectiveness of 70 Gene MammaPrint Signature in Node Negative Breast Cancer Publication Name The American Journal of Managed Care December 1 2010 Author s Er Chen MPP Kuo Bianchini Tong MS and Jennifer L Malin MD PhD Read More Biological Functions of the Genes in the Mammaprint Breast Cancer Profile Reflect the Hallmarks of Cancer Publication Name Biomarker Insights November 28 2010 Author s Sun Tian Paul Roepman Laura J van t Veer Rene Bernards Femke de Snoo and Annuska M Glas Read More Gene Expression Signature to Improve Prognosis Prediction of Stage II and III Colorectal Cancer Publication Name Journal of Clinical Oncology November 23 2010 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 Read More Identification of a low risk subgroup of HER 2 positive breast cancer by the 70 gene prognosis signature Publication Name British Journal of Cancer September 20 2010 Author s M Knauer F Cardoso J Wesseling PL Bedard SC Linn EJT Rutgers and LJ van t Veer Read More Comparison of MammaPrint and TargetPrint results with clinical parameters in German patients with early stage breast cancer Publication Name International Journal of Molecular Medicine July 30 2010 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 Read More Clinical Utility of the 70 gene MammaPrint Profile in a Japanese Population Publication Name Japanese Journal of Clinical Oncology June 1 2010 Author s Makoto Ishitobi Teodora Goranova Yoshifumi Komoike Kazuyoshi Motomura Hiroki Koyama Annuska Glas Ellen van Lienen Hideo Inaji Laura van t Veer and Kikuya Kato Read More Cost effectiveness of the 70 gene signature versus St Gallen guidelines and Adjuvant Online for early breast cancer Publication Name European Journal of Cancer May 1 2010 Author s Valesca Retel MA Joore WH van Harten Read More Use of a genomic test MammaPrint in daily clinical practice to assist in risk stratification of young breast cancer patients Publication Name Archives of Gynecology and Obstetrics March 19 2010 Author s Georg Kunz Read More The predictive value of the 70 gene signature for adjuvant chemotherapy in early breast cancer Publication Name Breast Cancer Research and Treatment March 5 2010 Author s Michael Knauer Stella Mook Emiel J T Rutgers Richard A Bender Michael Hauptmann Marc J van de Vijver Rutger H T Koornstra Jolien M Bueno de Mesquita Sabine C Linn Laura J van t Veer Read More MammaPrint 70 gene profile quantifies the likelihood of recurrence for early breast cancer Publication Name Expert Opinion Medical Diagnostics December 31 2009 Author s Phillipe L Bedard Stella Mook Martine J Piccart Gebhart Emiel T Rutgers Laura J van t Veer and Fatima Cardoso Read More Gene Expression profiling Decoding breast cancer Publication Name Surgical Oncology December 31 2009 Author s deSnoo F Bender R Glas G and Rutgers E Read More Microarray Based Determination of Estrogen Receptor Progesterone Receptor and HER2 Receptor Status in Breast Cancer Publication Name Clinical Cancer Research November 3 2009 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 Read More The 70 gene prognosis signature predicts early metastasis in breast cancer patients between 55 and 70 years of age Publication Name Annals of Oncology October 21 2009 Author s Mook S Schmidt MK Weigelt B Read More Validation of 70 gene prognosis signature in node negative breast cancer Publication Name Breast Cancer Research Treatment October 1 2009 Author s Bueno de Mesquita JM Keijzer R Linn SC Read More Gene expression profiling in breast cancer design of a pooled database to address open questions Publication Name European Surgery September 7 2009 Author s Michaël Knauer Etienne Wenzl Emiel J Rutgers Sabine C Linn Laura J van t Veer Read More 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 July 27 2009 Author s Mook S Schmidt M S Viale G Read More Thresholds for therapies highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer Publication Name Annals of Oncology June 17 2009 Author s Goldhirsch A Ingle JN Gelber RD et al Read More I SPY 2 An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy Publication Name Clinical Pharmacology Therapeutics May 13 2009 Author s Barker AD Sigman CC Kelloff GJ Hylton NM Berry DA Esserman LJ Read More Daily clinical practice of fresh tumour tissue freezing and gene expression profiling logistics

    Original URL path: http://www.agendia.com/publications/ (2016-05-01)
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  • Career Opportunities | Agendia
    orderly work area Adheres to department specific safety guidelines Physical Demands Standing sitting walking bending reaching manual manipulation and lifting up to 10 pounds All candidates must pass a color vision test Irvine CA USA Junior Quality Specialist Job Title Junior Quality Specialist Department Regulatory Affairs Quality Assurance Reports To Director Regulatory Affairs Compliance Job Summary The Junior Quality Specialist is responsible for supporting the Director Regulatory Affairs Compliance in setting up and maintaining certified quality system regulations of the laboratory organization as well as document control for laboratory related documentation The Junior Quality Specialist is a professional who highly delivers against commitments works well with people from across the business and constantly seeks ways to improve quality The Junior Quality Specialist reports to and works closely with the Director Regulatory Affairs Compliance Essential Duties and Responsibilities Under general direction and supervision of the Director Regulatory Affairs Compliance the Junior Quality Specialist will perform the following responsibilities Quality management system Handling and coordinating the activities of document control process including the review release distribution and auditing of controlled documents maintenance of electronic document control system tracking and reporting on document review progress Maintaining quality system documentation and also establishing a record management system in that maintaining organizing and archiving the quality documentation and records Train staff on specific quality management subjects such as document control system Conducting the internal quality audits of the quality management system including planning execution and reporting of internal audits Necessary corrective and preventive actions have been initiated Supporting the Director Regulatory Affairs Compliance Ensuring to ensure that suppliers vendors are selected and qualified based on performance and also required documentation is maintained Supporting the Director Regulatory Affairs Compliance in CAPA Corrective and Preventive Action process including the initiation of CAPAs through the follow up closure of CAPAs maintaining the CAPA records and documentations Supporting the Director Regulatory Affairs Compliance in set up implement and maintain the certified quality system and quality system regulations of the whole organization ISO 13485 QSR GLP CAP CLIA The Junior Quality Specialist is also responsible for providing support in setting up and organizing the annual Management Review and provide support during the external audits or inspection Follows all Agendia Inc s health and safety policies and procedures Performs other related duties as required or assigned Contacts The Junior Quality Specialist can work with various areas of the organization he she works especially close with the laboratory and department directors The Junior Quality Specialist should work independently work with department managers closely to facilitate cross functional activities as needed Education and Experience Requirements Bachelor s degree preferably with a concentration in life science biology or pharmacy degree 2 years of experience in CAP or CLIA laboratory with quality management task Skills and Qualifications Requirements Knowledge on CLIA and QSR GMP regulations Knowledge on internal auditing and CAPA s Desired Skills Proven experience with document control internal auditing Experience in MS tools such as Word Excel and electronic document control systems Supervisory

    Original URL path: http://www.agendia.com/careers/ (2016-05-01)
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  • Breast Cancer Healthcare Professionals | Agendia
    MD discusses the benefits of using the MammaPrint 70 Gene assay and the BluePrint 80 Gene assay in the treatment process for breast cancer Share This Video http www youtube com watch v dncAO2 5mFA Using Molecular Subtypes to more accurately predict response to therapies Dr Stephan Glück MD discusses the results of his study where BluePrint molecular subtyping more accurately identifies cancer subtypes with distinct improvements in pCR with neoadjuvant chemotherapy Share This Video http www youtube com watch v kbtrWtHDmgI Using Molecular Subtypes to more accurately predict response to therapies Dr Stephan Glück MD discusses the results of his study where BluePrint molecular subtyping more accurately identifies cancer subtypes with distinct improvements in pCR with neoadjuvant chemotherapy Share This Video http www youtube com watch v kbtrWtHDmgI Breast cancer is heterogeneous disease Dr Rene Bernards PhD co developer of MammaPrint discusses how breast cancer biology drove the discovery of the 70 Gene Breast Cancer Recurrence Assay Share This Video http www youtube com watch v AS gJFzEY44 Breast cancer is heterogeneous disease Dr Rene Bernards PhD co developer of MammaPrint discusses how breast cancer biology drove the discovery of the 70 Gene Breast Cancer Recurrence Assay Share This Video http www youtube com watch v AS gJFzEY44 UPMC study results at ASCO 2014 Dr Adam Brufsky MD PhD discusses a study comparing MammaPrint to the 21 gene assay and how BluePrint molecular subtyping compares to traditional subtyping Share This Video http www youtube com watch v u2pzHLBHYns UPMC study results at ASCO 2014 Dr Adam Brufsky MD PhD discusses a study comparing MammaPrint to the 21 gene assay and how BluePrint molecular subtyping compares to traditional subtyping Share This Video http www youtube com watch v u2pzHLBHYns Personalizing Breast Cancer treatment with MammaPrint and BluePrint Learn how Dr

    Original URL path: http://www.agendia.com/healthcare-professionals/ (2016-05-01)
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  • Colon Cancer | Agendia
    identify patients who are more likely to benefit from adjuvant treatment Gene expression profiles such as ColoPrint provide clinicians a more robust tool to tailor treatments based on the biology of a patient s disease Development Unbiased development 21 Agendia assessed 188 untreated tumor samples with 10 year patient follow up and known outcomes An unbiased analysis of the entire human genome was used to isolate the most predictive genes for colon cancer relapse The signature development process began by identifying two patient groups those who developed distant metastases within 5 years and those who were cancer free at 5 years The resulting difference in gene expression pattern was captured in an 18 gene signature Unsupervised hierarchical clustering showed three main molecular subtypes Patient s with subtype A showed good clinical outcome and patients with subtype C had relatively poor outcome 84 and 58 5 year disease free survival respectively After further investigation the patients in subtype B group were shown to have less BRAF v600E mutations and were not MSI High Microsatellite instability Only subtype B was used for the development of the signature n 110 to avoid the building of a classifier based on known expression patterns Adapted from Salazar et al JCO 2011 Click image to enlarge Validation As published in the Journal of Clinical Oncology in 2011 ColoPrint classified 60 of patients as Low Risk and 40 of patients as High Risk The study was performed on primarily Stage II samples 114 206 of colorectal cancer Low Risk patients had a 5 year relapse free survival RFS of 87 6 95 CI 81 5 to 93 7 whereas high risk patients had a 5 year RFS rate of only 67 2 95 CI 55 4 to 79 When applied to Stage II patients only 63 2 were classified as low risk and 36 8 were classified as high risk with 5 year RFS rates of 90 9 95 CI 84 to 97 8 and 73 9 95 CI 59 2 to 88 6 respectively P 0 017 21 In a second independent study of 135 patients with stage II colon cancer ColoPrint identified 73 3 of patients as Low Risk with a 5 year DMFS of nearly 95 High Risk patients accounted for 26 7 of patients with a DMFS of 80 6 p 0 009 19 To date ColoPrint has been clinically validated in over 1 000 patients in four independent studies in Europe and the U S and is the subject of the PARSC prospective study ongoing since 2008 These studies have shown that gene expression profiling is superior to current criteria for determining the risk of colon cancer recurrence 7 In several independent studies ColoPrint was compared to all relevant clinical factors age gender localization of tumor grade less than 12 lymph nodes assessed and T stage and to a combination of the factors that define patients as high risk according to ASCO recommendation or NCCN guidelines In all studies ColoPrint was the

    Original URL path: http://www.agendia.com/healthcare-professionals/colon-cancer/ (2016-05-01)
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  • Ordering & Client Login | Agendia
    our Customer Care representatives at 31 20 462 1510 or by email at customerservice agendia com and they will be happy to help NEW Americas Test Request Form TRF Click below to download and print a paper TRF Please complete and fax to 866 756 7548 Include a copy in the specimen transportation kit provided Outside the Americas Test Request Form TRF Click below to download and print a paper TRF Please complete and fax to 31 20 462 1505 Include a copy in the specimen transportation kit provided Agendia Online Customer Portal Your tool to securely streamline Agendia case management Specimen Requirements Formalin Fixed Paraffin Embedded Tissue FFPE Specimen Block with invasive tumor OR 10 unstained slides with a 5 micron section on each slide at least 30 of invasive tumor FFPE Tissue Sampling Instructions Specimen Requirements Fresh tissue Core needle biopsies or tissue taken from a surgical specimen Fresh specimen at least 3 3 mm tic tac size preserved in RNARetain Note Maximum side dimension should not exceed 5 mm to allow adequate penetration of RNARetain Fresh Tissue Sampling Instructions For additional information on specimen sampling instructions or specimen requirements please contact our Customer Care representatives at 888 321 2732 or by email at customercare agendia com and they will gladly assist you Outside the Americas Please contact our Customer Care representatives at 31 20 462 1510 or by email at customerservice agendia com and they will be happy to help Specimen Collection and Transportation Kit Ordering To order Specimen and Transportation Kits please click on the button to submit a request Note Please allow up to four business days for delivery For Americas customers only Order Kits Each kit contains all the necessary components to prepare and submit a tumor specimen to Agendia Sturdy outer box including

    Original URL path: http://www.agendia.com/healthcare-professionals/breast-cancer/ordering-login/ (2016-05-01)
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  • Unbiased gene selection, based on patient outcomes | Agendia
    the forefront of cancer translational research Agendia s founders Dr Rene Bernards and Dr Laura van t Veer of the Netherlands Cancer Institute in Amsterdam sought to utilize this information to help improve the lives of those who have been affected by breast cancer Drs Bernards and van t Veer hypothesized that since breast cancer is a genetic heterogeneous disease gene expression should be different in aggressive breast tumors that develop recurrences following surgery from those that are less aggressive and do not recur or spread throughout the body To identify a novel and independent predictor of breast cancer recurrence they utilized DNA microarray technology to assess the activity of 25 000 genes rather than pre selecting a few genes based on literature and known information They allowed tumor biology to uncover which genes were most predictive of known patient outcomes This unbiased approach helps ensure that as even as breast cancer biology evolves the genes selected and assay approach stays relevant In addition to interrogating the full human genome the researchers evaluated breast tumors from untreated patients Unlike other approaches this key differentiator allows physicians to confidently know their patient s risk of recurrence without any treatment bias or assumptions therefore patients do not have to earn their recurrence result Click image to enlarge Using the approaches above Drs Bernards and van t Veer identified a group of 70 genes that were most predictive of breast cancer recurrence This ground breaking work was published in the prestigious scientific journals Nature and New England Journal of Medicine in 2002 This 70 gene diagnostic test was called MammaPrint Agendia s molecular diagnostic portfolio is developed utilizing this same approach By analyzing all genes in the human genome and using known patient outcomes we let the cancer biology tell us which genes

    Original URL path: http://www.agendia.com/our-science/ (2016-05-01)
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