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  • Agendia and CBLPath Announce Agreement to Assist Physicians in Diagnostic Assessment of Breast Cancer | Agendia
    physicians who treat breast cancer and women who have the disease Pathologists approach to breast cancer diagnosis is being significantly advanced by molecular diagnostics said Carlos D Urmacher M D FCAP FASCP Co Chief Executive Officer and Chief Medical Officer of CBLPath CBLPath s expertise in breast pathology coupled with Agendia s innovative tests will provide definitive information for breast cancer patients and their physicians when evaluating treatment options Given the prominence of CBLPath and Agendia in providing sophisticated laboratory services in this field I look forward to a powerfully synergistic relationship between the two companies About Agendia Agendia is a leading molecular diagnostics company that develops and markets FFPE based genomic diagnostic products which help support physicians with their complex treatment decisions Agendia s tests were developed using an unbiased gene selection by analyzing the complete human genome This includes MammaPrint as well as BluePrint a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology MammaPrint is the only breast cancer recurrence assay backed by peer reviewed prospective outcome data These tests can help physicians assess a patient s individual risk for metastasis which patients may benefit from chemo hormonal or combination therapy and which patients may not require these treatments and can instead be treated with other less arduous and less costly methods In addition Agendia has a pipeline of other genomic products in development The company collaborates with other companies leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY 2 and the MINDACT trials For more information visit www agendia com About CBLPath CBLPath a Sonic Healthcare USA laboratory is a leading pathology services provider combining anatomic pathology with advanced molecular diagnostics esoteric testing and digital pathology CBLPath

    Original URL path: http://www.agendia.com/agendia-and-cblpath-announce-agreement-to-assist-physicians-in-diagnostic-assessment-of-breast-cancer/ (2016-05-01)
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  • Value of Breast Cancer Molecular Subtyping Documented by Independent Study Comparing Genomic Tests at ASCO 2014 Meeting | Agendia
    surgery These tests are the only widely available assays that provide functional molecular subtyping to guide breast cancer treatment decisions By looking at the activity of the genes through molecular subtyping the 80 gene test tells us more about what s happening in the cancer cells Dr Brufsky said In another study presented at ASCO researchers from MedStar Washington Hospital Center reported African American women are more likely to be diagnosed with higher risk breast cancer Their study used MammaPrint and BluePrint to determine recurrence risk and molecular subtype in a group of 100 African American women with breast cancer Patients in that group often presented with disease that had a high risk of recurrence regardless of the stage of the disease More information on the study is available here The University of Pittsburgh and MedStar Washington studies were two of seven Agendia related scientific posters presented at ASCO Those findings and a podium presentation documented the latest research and clinical successes with Agendia s genomic tests which use molecular diagnostic analysis and personalized medicine to help clinicians improve treatment of breast cancer and colon cancer Among the other studies at ASCO Peter Beitsch M D of Medical City Dallas Hospital and colleagues reported data from the NBRST registry in which 55 U S institutions utilizing TheraPrint were able to identify 15 gene expression markers that correlated with response to neoadjuvant presurgical chemotherapy as part of breast cancer treatment Researchers concluded that the novel TheraPrint assay from Agendia can help predict a patient s preoperative response to chemotherapy thereby making a potentially valuable contribution to clinical decision making Also at ASCO a research team headed by Pat Whitworth M D Nashville Breast Center reported that molecular subtyping using MammaPrint and BluePrint more accurately reclassified 23 of 336 tumors that were initially classified using traditional IHC FISH pathology methods The research is also part of the Neoadjuvant Breast Registry Symphony Trial NBRST trial Three other studies detailed aspects of Agendia s molecular diagnostics technology as applied to colorectal cancer Drawing on a large international study Ramon Salazar M D Ph D M Sc reported on the successful identification of molecular subtypes of colorectal cancer using Agendia technology The scientific poster also concluded that a treatment strategy combining standard drugs to treat colorectal cancer along with agents that suppress a specific cell signaling pathway may benefit patients who fit one of the subtypes identified in the research Dr Salazar is Head of Translational Research at the Catalan Institute of Oncology Barcelona Spain A separate scientific poster from Dr Salazar and others reported comparisons between Agendia s ColoPrint colorectal cancer assay and risk stratification using criteria from the National Comprehensive Cancer Network The data is part of the prospective international PARSC study assessing recurrence risk in Stage II colorectal cancer patients using the 18 gene ColoPrint test In a podium presentation Rodrigo Dienstmann M D Ph D of Sage Bionetworks Seattle Wash detailed open source international research into molecular subtypes of colorectal cancer

    Original URL path: http://www.agendia.com/value-of-breast-cancer-molecular-subtyping-documented-by-independant-study-comparing-genomic-tests-at-asco-2014-meeting-2/ (2016-05-01)
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  • Agendia Genomic Tests (MammaPrint, BluePrint & TargetPrint) Among Highlights of San Antonio Breast Cancer Symposium | Agendia
    molecular subtype of the cancer and how best to treat to it At SABCS Dr Gluck detailed his research for a select group of oncology key opinion leaders He is the Sylvester Professor in the Department of Medicine Division of Hematology Oncology Sylvester Comprehensive Cancer Center at the University of Miami Leonard M Miller School of Medicine Among the podium presentations were first efficacy results from the I SPY II Breast Cancer Clinical Trial presented by Hope S Rugo M D Clinical Professor in the Department of Medicine at the UC San Francisco and Director of its Breast Oncology Clinical Trials Program MammaPrint was selected by academic government and industry leaders as the biomarker of choice for the I SPY II Trial which along with the MINDACT trial makes Agendia the new leader in patient stratification for clinical trials utilizing MammaPrint for frontline stratification of six approved and five early stage cancer therapeutics Also presenting Symphony related information from the podium was Laura van t Veer Ph D a world renowned molecular biologist the inventor of MammaPrint and a breast oncology program leader at UCSF Her talk was titled Genomics Variation underlying Breast Cancer Heterogeneity Several of the 10 scientific posters about the Symphony tests focused on the advantages of molecular subtyping including these Researchers reported that MammaPrint and BluePrint are better than traditional clinical pathology methods at classifying the nature of a woman s breast cancer thereby allowing physicians to more precisely tailor each patient s treatment The multi site research was presented by Massimo Cristofanilli M D Director of the Jefferson Breast Care Center at the Kimmel Cancer Center and Thomas Jefferson University and Hospitals in Philadelphia MammaPrint and BluePrint can better predict how a breast cancer patient will respond to neoadjuvant pre surgical chemotherapy according to another multi site poster Molecular subtyping assists physicians as they determine whether the side effects endured by the patient are worth the additional benefit gained by chemotherapy said presenter Peter Beitsch M D a breast surgeon at Medical City Dallas who is also president of the American Society of Breast Surgeons These multiple presentations conclusively demonstrated Agendia s leadership in genomic testing for breast cancer said David Macdonald the company s CEO We were also very pleased to see the enormous interest in our tests throughout the San Antonio conference and the continuing growth in adoption of the Symphony suite of tests MammaPrint is the first FDA cleared test to determine recurrence risk in breast cancer patients Symphony is the only predictive multi gene breast cancer panel that is based on prospective trials including outcome data e g the RASTER study The Agendia tests have substantial insurance coverage encompassing an estimated 170 million lives and including coverage by Medicare and regional and national insurers About Agendia Agendia is a leading molecular diagnostic company that develops and markets FFPE based genomic diagnostic products which help support physicians with their complex treatment decisions Agendia s breast cancer Symphony suite was developed using unbiased

    Original URL path: http://www.agendia.com/agendia-genomic-tests-mammaprint-blueprint-targetprint-among-highlights-of-san-antonio-breast-cancer-symposium/ (2016-05-01)
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  • Agendia Announces Presentation of Data Highlighting Symphony Suite of Genomic tests (MammaPrint, BluePrint, and TargetPrint) at San Antonio Breast Cancer Symposium | Agendia
    Booth 456 Among the SABCS posters featuring genomic tests from Agendia are Wednesday December 11 2013 Poster P1 02 02 Session 1 Concordance of microarray based determination of ER PR and HER2 receptor status and local IHC FISH assessment in the prospective Neo adjuvant Breast Registry Symphony Trial NBRST Authors Beitsch P Gittleman M Akbari S Stork Sloots L de Snoo F Bigson J Whitworth P Exhibit Halls A B Time 5 7 p m Poster P1 08 02 Session 1 Chemosensitivity and endocrine sensitivity predicted by MammaPrint and BluePrint in the prospective Neo adjuvant Breast Registry Symphony Trial NBRST Authors Whitworth P Gittleman M Akbari S Stork Sloots L de Snoo F Gibson J Beitsch P Exhibit Halls A B Time 5 7 p m Poster O T1 2 02 Session 1 PROMIS Prospective study of MammaPrint in breast cancer patients with an intermediate recurrence score PROMIS Authors Soliman HH Untch S Stork Sloots L Exhibit Halls A B Time 5 7 p m Thursday December 12 2013 Poster P2 11 13 Session 2 The 70 gene signature 70 GS in a lymph node negative patient series with intermediate risk 21 gene recurrence scores RS and known adjuvant treatment recommendations Authors Lo SS Mai H McCroskey Z Guo R Ersahin C Gaynor ER Robinson PA Albain KS Exhibit Halls A B Time 7 9 a m Poster P2 11 23 Session 2 MammaPrint and BluePrint in early breast cancer Clinical implications of prognostic stratification and molecular subtyping Authors Yao K Turk M Kaul K Wesseling J Stork Sloots L de Snoo F Cristofanilli M Exhibit Halls A B Time 7 9 a m Saturday December 14 2013 Poster P6 06 50 Session 6 Obesity and the influence on tumor biology as determined by the intermediate risk 21 gene recurrence scores RS and the 70 gene breast cancer recurrence signature 70 GS assay Authors Robinson P Mai H Guo R Gaynor E McCroskey Z Ersahin C Albain K Lo S Exhibit Hall C Time 7 30 9 a m MammaPrint is the first FDA cleared test to determine recurrence risk in breast cancer patients Symphony is the only predictive multi gene breast cancer panel that is based on prospective trials including outcome data e g the RASTER study The Agendia tests have substantial insurance coverage encompassing an estimated 170 million lives and including coverage by Medicare and regional and national insurers SABCS will be held Dec 10 14 in the Henry B Gonzalez Convention Center in San Antonio Texas About Agendia Agendia is a leading molecular diagnostic company that develops and markets FFPE based genomic 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 and TargetPrint an ER PR HER2 expression assay

    Original URL path: http://www.agendia.com/agendia-announces-presentation-of-data-highlighting-symphony-suite-of-genomic-tests-mammaprint-blueprint-and-targetprint-at-san-antonio-breast-cancer-symposium/ (2016-05-01)
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  • Multiple International Breast Cancer Guidelines Confirm Use of Agendia Tests for Prognostic, Predictive Information in Cancer Treatment Decisions | Agendia
    a progressive recognition of our technologies by the panels of international experts and their guidelines said Agendia CEO David Macdonald It is very rewarding to see that multiple thought leaders and industry guidelines throughout the world now include our MammaPrint test We are working with all of our physician partners in adopting this clinical advantage for their patients Third party payors are seeing the clinical and economic benefit of using a more precise instrument for their insured lives Specifically the ESMO and JSMO guidelines included For staging and risk assessment gene expression profiles such as MammaPrint Agendia may be used to gain additional prognostic and or predictive information to complement pathology assessment and to predict response to adjuvant chemotherapy For adjuvant systemic treatment in case of uncertainty regarding indications for adjuvant chemotherapy after consideration of other tests gene expression assays such as MammaPrint may be used where available to determine the individual recurrence risk and predict the benefit from chemotherapy In addition the St Gallen guidelines strongly endorsed the need for intrinsic subtyping of patients as an accurate means of determining which patients need to undergo chemotherapy The only commercially available genomic assay in the U S that can perform comprehensive molecular subtyping is Agendia s Symphony suite of breast cancer tests The St Gallen panel was strongly of the opinion that intrinsic subtypes should influence whether or not chemotherapy was used The panel guidelines also noted that in those areas of the world where multi gene molecular assays are readily available many clinicians prefer to base chemotherapy decisions for patients with luminal disease on these genomic results The guidance to physicians on the importance of subtyping and how that affects treatment decisions is one of the most significant messages that came out of the St Gallen conference said Neil Barth M D Agendia s Chief Medical Officer Our Symphony suite of breast cancer tests offers treating physicians critical information not only about which patients may safely forgo chemotherapy versus those who truly benefit from chemotherapy but also more accurately identify the specific genomic pathways that can be optimally targeted Ten clinical validation studies over the last several years have affirmed the contribution to clinical care for patients who were provided with the opportunity to have their tumors tested at Agendia These studies have spanned neoadjuvant to adjuvant and prospective to retrospective studies Notable mention in the St Gallen guidelines publication was given to the recently published RASTER study where 97 of patients who were identified as Low Risk by MammaPrint and chose not to have chemotherapy were disease free at five years RASTER remains the only published prospective study for breast cancer recurrence tests with patient outcome data About Agendia Agendia is a leading molecular diagnostic company that develops and markets FFPE based genomic 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 clinically actionable definitive results for cancer

    Original URL path: http://www.agendia.com/multiple-international-breast-cancer-guidelines-confirm-use-of-agendia-tests-for-prognostic-predictive-information-in-cancer-treatment-decisions/ (2016-05-01)
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  • Researchers Identify Splice Variant of Breast Cancer Gene that Can Mask Risk of Recurrence | Agendia
    the importance of the delta Exon 7 deletion through a test called BluePrint which was developed by Agendia BluePrint is one part of a suite of related breast cancer tests called Symphony which provides a complete view of a patient s prognosis and help guide their individual treatment decisions through genomic profiling The researchers identified the presence of the Exon 7 variant of the estrogen receptor while trying to determine why some breast cancer patients who tested ER in the classical test for receptor status turned out to be of the basal like subtype by the BluePrint assay which indicates a lack of a functional estrogen pathway noted Stephanie R Akbari M D Medical Director of the Reinsch Pierce Family Center for Breast Health at Virginia Hospital Center a member of the research team Medical experts have long established that ER tumors typically benefit from hormonal therapies but we also know that not all patients with ER tumors benefit from this therapy This finding may help identify those patients that are unlikely to benefit from hormonal therapy Dr Akbari said Our findings show that as we discover the importance of splicing variants such as Exon7 additional molecular subtyping of a patient s tumor is necessary to reach a more accurate understanding of the disease Agendia CEO David Macdonald said Agendia s Symphony is the only commercially available test suite that provides molecular subtyping and can identify the growing body of important genetic variants such as Exon 7 This research underscores Agendia s commitment to ongoing discovery and collaboration between industry and physician directed research in bringing scientific advances into clinical practice About Agendia Agendia is a leading molecular diagnostic company that develops and markets FFPE based genomic diagnostic products Agendia s breast cancer Symphony suite was developed by analyzing the

    Original URL path: http://www.agendia.com/researchers-identify-splice-variant-of-breast-cancer-gene-that-can-mask-risk-of-recurrence/ (2016-05-01)
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  • Molecular Subtyping Can Help Determine Prognosis and Chemotherapy Benefit in Colorectal Cancer Patients | Agendia
    the widely recognized TCGA The Cancer Genome Atlas dataset Different patients have different responses to treatment for colorectal cancer because of the underlying biology of the tumor Having this new information about molecular subtypes provides valuable information regarding prognosis and treatment said poster co author Scott Kopetz M D Ph D FACP a medical oncologist at The University of Texas MD Anderson Cancer Center We now know that along with clinical pathological risk factors the subtype is clinically relevant in the treatment decision process The research was presented by primary author Ramon Salazar M D Ph D of the Catalan Institute of Oncology in Barcelona Spain along with Dr Kopetz Other co authors of the study were from the Netherlands Germany and Austria Another poster at the ASCO meeting reported on the new independent validation study of the genomic classifier ColoPrint made by Agendia which predicts outcome and chemotherapy benefit in Stage II and III colon cancer patients The study concluded that ColoPrint significantly improves prognostic accuracy in Stage II and Stage III colon cancer patients thereby supporting physicians decisions on which patients would most benefit from chemotherapy and which patients would not Three posters regarding breast cancer reported on The effectiveness of MammaPrint and BluePrint in identifying molecular subtypes of breast tumors as a predictor for tumor response to targeted chemotherapies The MammaPrint MINT study assessing the ability of molecular profiling and traditional pathologic and clinical prognostic factors to predict patient response to neo adjuvant chemotherapy Genomic profiling of breast cancer in African American women The ASCO meeting was held in Chicago May 31 June 4 2013 About Agendia Agendia is a leading molecular diagnostic company that develops and markets FFPE based genomic diagnostic products Agendia s breast cancer Symphony suite was developed by analyzing the complete human genome

    Original URL path: http://www.agendia.com/molecular-subtyping-can-help-determine-prognosis-and-chemotherapy-benefit-in-colorectal-cancer-patients/ (2016-05-01)
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  • Study Indicates Breast Cancer Diagnosis Is More Accurate with New Genomic Tests | Agendia
    patients do not need to undergo treatments such as chemotherapy when that treatment would be expensive and would not be useful to that particular patient said medical oncologist Massimo Cristofanilli M D FACP lead author of the study and chief of the breast service line at Fox Chase Cancer Center in Philadelphia Chemotherapy risks include immediate side effects discomfort and long term damage including a possible second cancer Several studies have concluded that chemotherapy provides no real benefit for many breast cancer patients because of their cancer subtype and low risk of recurrence These research findings contribute to our understanding of how cancer grows and how that growth can be stopped and the findings will help us treat more patients more successfully said Stefan Gluck M D Ph D FRCPC a medical oncologist at the University of Miami With the new genomic tests physicians will be able to more precisely employ the sophisticated treatments that have been developed for breast cancer said Dr Cristofanilli Our sophisticated therapies mean nothing if we cannot apply them to patients appropriately This newer panel of genomic tests enables us to better classify patients That will help improve outcomes because we will be more precisely applying the right treatment to the right patient Study details Breast cancer tumors have traditionally been classified using so called immunochemistry IHC and fluorescent in situ hybridization FISH techniques The San Antonio study compared the accuracy of IHC and FISH results to two genomic tests MammaPrint and BluePrint part of the Symphony panel of genomic tests Dr Cristofanilli and study co authors retrospectively analyzed 208 tumor samples from breast cancer patients whose age survival and cancer pathology findings were known Median follow up on those 208 patients was 11 3 years The study compared the accuracy of the genomic tests to the IHC and FISH tests that were done at the time each patient had been diagnosed Researchers concluded that the new genomic tests provided a more accurate method for determining a patient s disease subtype which helps establish a patient s risk of breast recurrence and identify the most appropriate adjuvant therapy One message is that we cannot any longer afford to use the older methods alone for breast cancer prognosis and treatment planning said Dr Cristofanilli Study co author Katharine Yao M D a breast surgeon at NorthShore University HealthSystem in Evanston Ill said the San Antonio study findings could influence the guidance that physicians give their breast cancer patients This information can help doctors determine who the best candidates are for neoadjuvant therapy she said Neoadjuvant chemotherapy is sometimes used to shrink a tumor prior to its removal by surgery The study can also help breast surgeons better inform their patients about what type of tumor they have and how they can best move on to their treatment she said The National Cancer Institute estimates that in the U S in 2012 226 870 women will be diagnosed with and 39 510 women will die of breast

    Original URL path: http://www.agendia.com/study-indicates-breast-cancer-diagnosis-is-more-accurate-with-new-genomic-tests/ (2016-05-01)
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