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  • MammaPrint the 70-gene signature – another milestone in personalized medical care for breast cancer patients. | Agendia
    fully commercialized microarray based multigene assay designed to individualize treatment for patients with breast cancer MammaPrint the first assay to be cleared at the 510 k level by the US FDA s new in vitro diagnostic multivariate index assay classification is offered as a prognostic test for women under the age of 61 years with either estrogen receptor positive or negative lymph node negative breast cancer Unlike the Oncotype DX assay Genomic Health CA USA this test requires freshly prepared tissues collected into an RNA preservative solution The 70 genes that comprise the MammaPrint assay are focused primarily on proliferation with additional genes associated with invasion metastasis stromal integrity and angiogenesis The Microarray In Node negative Disease may Avoid Chemotherapy MINDACT trial sponsored by the European Organization for Research and Treatment of Cancer involves the assessment of patients in the adjuvant treatment setting by the standard clinicopathologic prognostic factors included on Adjuvant Online and by the 70 gene MammaPrint assay The following article will consider the basic biology technology ease of clinical use level of clinical validation and potential clinical utility of this test See article Categories Abstract Poster 18 Accreditation 1 BluePrint 9 Clinical Studies 8 ColoPrint 5 Cost

    Original URL path: http://www.agendia.com/mammaprint-the-70-gene-signature-%c2%96-another-milestone-in-personalized-medical-care-for-breat-cancer-patients/ (2016-05-01)
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  • Enabling personalized cancer medicine through analysis of gene-expression patterns | Agendia
    that are targeted to each tumour To facilitate this shift tests need to be developed to identify those individuals who require therapy and those who are most likely to benefit from certain therapies In particular tests that predict the clinical outcome for patients on the basis of the genes expressed by their tumors are likely to increasingly affect patient management heralding a new era of personalized medicine See article Categories

    Original URL path: http://www.agendia.com/enabling-personalized-cancer-medicine-through-analysis-of-gene-expression-patterns/ (2016-05-01)
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  • On the Toxicity of Chemotherapy for Breast Cancer – —the Need for Vigilance | Agendia
    Releases Collaborations Contact Us Search for Search More Publications On the Toxicity of Chemotherapy for Breast Cancer the Need for Vigilance Publication Name Journal of the National Cancer Institute Editorial Author s John K Erban Joseph Lau January 1 2006 A study published in The Journal of the National Cancer Institute found that advanced chemotherapy put patients at far greater risks of harm than adverse effect reports from clinical trial data reveal Researchers mined insurance claims for 3 526 women who had intravenous chemotherapy for breast cancer and tallied problems serious enough to require emergency care or a hospital stay They found Overall 16 of women in the new study had at least one of eight side effects that required emergency care or hospitalization Side effects also included blood clots dehydration nausea and diarrhea See article 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 Patient Education Breast Cancer

    Original URL path: http://www.agendia.com/on-the-toxicity-of-chemotherapy-for-breast-cancer-%c2%97-the-need-for-vigilance/ (2016-05-01)
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  • Microarray-based determination of ER, PR and HER2 receptor status: validation and comparison with IHC assessments | Agendia
    with IHC assessments Publication Name Poster SABCS 2008 Author s Paul Roepman Hugo Horlings Oscar Krijgsman Jolien Bueno de Mesquita Richard Bender Sabine Linn Annuska Glas and Marc van de Vijver January 15 2009 In breast cancer patients the level of expression of estrogen receptor ER progesterone receptor PR and HER2 is predictive for prognosis and or treatment response However differences in assessment methods and interpretation can substantially affect the accuracy and reproducibility of the results Previously we have determined the association between immunohistochemistry IHC and mRNA levels for ER PR and HER2 and have confirmed the accuracy of microarray readout on 450 samples ref 1 In the current study we describe the use of this microarray based readout on prospectively collected samples We compared these readouts with multiple IHC and fluorescent in situ hybridization FISH assessments generated in various hospitals and a CLIA certified reference laboratory and developed a microarray based test called TargetPrint TM 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

    Original URL path: http://www.agendia.com/microarray-based-determination-of-er-pr-and-her2-receptor-status-validation-and-comparison-with-ihc-assessments/ (2016-05-01)
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  • Study shows half of early-stage breast cancer patients may be able to avoid chemotherapy | Agendia
    Publication Name Video February 25 2013 WFTS Tampa 2013 A diagnosis of early stage breast cancer doesn t always mean you need to use chemotherapy a new study shows 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/news2/ (2016-05-01)
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  • MammaPrint breast cancer test ID’s women who can avoid chemotherapy | Agendia
    Minneapolis St Paul 2013 This TV report tells how you can know your breast cancer better through this genomic personalized medicine test which is part of the Symphony suite of breast cancer tests 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

    Original URL path: http://www.agendia.com/mammaprint-breast-cancer-test-ids-women-who-can-avoid-chemotherapy/ (2016-05-01)
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  • Breast cancer survivor describes how Symphony helped her avoid chemotherapy to the House Medical Technology Caucus on Capital Hill | Agendia
    her avoid chemotherapy to the House Medical Technology Caucus on Capital Hill Publication Name Video January 31 2013 December 2012 AdvaMed Dx 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

    Original URL path: http://www.agendia.com/breast-cancer-survivor-describes-how-symphony-helped-her-avoid-chemotherapy-to-the-house-medical-technology-caucus-on-capital-hill/ (2016-05-01)
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  • Agendia Receives New FDA Clearance for MammaPrint FFPE Breast Cancer Test | Agendia
    the first ever five year clinical outcome study RASTER in which MammaPrint results were utilized by physicians to decide post surgical management In that real world study patients were treated according to the best standard of care Patients with a Low Risk MammaPrint score had a 97 7 probability of being cancer free at five years while those with a High Risk score had an 88 5 probability of being cancer free In a univariate analysis against other clinical pathologic factors MammaPrint s prognostic value is highly statistically significant P 0 002 Originally cleared in 2007 Agendia was the first company to have FDA clearance for its breast cancer genomic test said Egberts This sixth FDA clearance further reinforces our positive relationship with the FDA and our leadership in the molecular diagnostic field In July of 2014 the FDA publicly announced that it intends to publish a risk based oversight framework for LDTs Ensuring that doctors and patients have access to safe accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA said FDA Commissioner Margaret A Hamburg M D Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether Today s action demonstrates the agency s commitment to personalized medicine which depends on accurate and reliable tests to get the right treatment to the right patient We actively support the FDA s objective that doctors and patients should have access to safe accurate and reliable diagnostic tests and we support the FDA in taking a strong stance to regulate Laboratory Developed Tests LDT s The absence of FDA enforcement over high risk non FDA cleared LDTs raises concern about the reliability reproducibility and efficacy of these non approved tests Egberts added Our longstanding working relationship with the FDA has been a favorable experience We are hopeful that once this enforcement is operationalized it will eliminate the unfair commercial advantage currently enjoyed by vendors whose claims have not been subject to the rigorous FDA review and approval process In the minds of clinicians this decision will ease the process to choose MammaPrint from among other commercially available tests said Dr Massimo Cristofanilli a medical oncologist and Director of the Jefferson Breast Center and Clinical Program at Sidney Kimmel Cancer Center at Thomas Jefferson University Doctors and patients typically rely on a number of factors when selecting a clinical test The FDA clearance provides reassurance that tests have been sufficiently reviewed and validated and are clinically indicated and useful With this FDA clearance Agendia has taken its next step in a continuing tradition of scientific excellence and clinical and social responsibility to patients worldwide MammaPrint has substantial insurance coverage including by Medicare and regional and national insurers encompassing an estimated 200 million lives in the U S Resources for further reference RASTER prospective outcome study and press release Independent comparison validates molecular subtyping includes video MammaPrint valid up to 25 years press release About Agendia Agendia is a

    Original URL path: http://www.agendia.com/agendia-receives-new-fda-clearance-for-mammaprint-ffpe-breast-cancer-test/ (2016-05-01)
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