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  • Agendia Announces Five Studies in Breast Cancer for Presentation at the American Society of Clinical Oncology 2012 Breast Cancer Symposium | Agendia
    abstracts listed below can currently be found online at www ASCO org Presentation details are as follows all times are in Pacific Time Thursday September 13 2012 1 Poster Presentation 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 Lead Author G Viale L Slaets F De Snoo L J van t Veer E J Rutgers J Bogaerts L Stork Sloots K Engelen L Russo P Dell Orto F Cardoso M J Piccart Gebhart Presentation Time 11 00 AM 1 00 PM 5 30 PM 7 00 PM Location Golden Gate Hall 2 Poster Presentation and Discussion Molecular subtyping using MammaPrint and BluePrint as an outcome predictor in U S breast cancer BC patients Lead Author K Yao M Turk K Kaul J Weaver F De Snoo L Stork Sloots M Cristofanilli Presentation Time 11 00 AM 1 00 PM 5 30 PM 7 00 PM Location Golden Gate Hall Discussion Time 4 30 PM 5 30 PM Location Yerba Buena Ballroom Salon 8 3 Poster Presentation and Discussion Response and long term outcomes after neo adjuvant chemotherapy Pooled dataset of patients stratified by molecular subtyping by MammaPrint and BluePrint Lead Author S Gl ü ck F De Snoo J Peeters G Somlo L Stork Sloots L J van t Veer Presentation Time 11 00 AM 1 00 PM 5 30 PM 7 00 PM Location Golden Gate Hall Discussion Time 4 30 PM 5 30PM Location Yerba Buena Ballroom Salon 8 4 Poster Presentation and Discussion Central review of discordant samples for microarray based on ER PR and HER2 and local IHC FISH assessment worldwide from 827 patients Lead Author J Wesseling C Tinterri A Sapino F Zanconati M Lutke Holzik B Nguyen K B Deck P Querzoli T Perin C Giardina G Seitz J M Guinebretiere J Barone T Watanabe F De Snoo L Stork Sloots P Cusumano Presentation Time 11 00 AM 1 00 PM 5 30 PM 7 00 PM Location Golden Gate Hall Discussion Time 4 30 PM 5 30 PM Location Yerba Buena Ballroom Salon 8 5 Poster Presentation and Discussion Gene expression panel TheraPrint analyzed as predictors of response to neo adjuvant chemotherapy NCT in patients pts with stage II III and inflammatory breast cancer BC Lead Author G Somlo F De Snoo J Peeters L Stork Sloots I Simon K Robinson Presentation Time 11 00 AM 1 00 PM 5 30 PM 7 00 PM Location Golden Gate Hall Discussion Time 4 30 PM 5 30 PM Location Yerba Buena Ballroom Salon 8 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

    Original URL path: http://www.agendia.com/agendia-announces-five-studies-in-breast-cancer-for-presentation-at-the-american-society-of-clinical-oncology-2012-breast-cancer-symposium/ (2016-05-01)
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  • Agendia Brings Together Thought Leaders in Molecular Diagnostics and Medical Oncology | Agendia
    beginning of the precision medicine revolution The event featured an impressive list of speakers and panels on the following topics The Science Behind Genomic Based Analysis of Breast Cancer René Bernards PhD Chief Scientific Officer and Co Founder Agendia Clinical Utility of Molecular Diagnostics Ralph V Boccia MD FACP Clinical Associate Professor of Medicine Georgetown University Landmark Clinical Trials Stefan Glück MD FRCP C PhD Sylvester Professor Miller School of Medicine University of Miami Tumor Round Table Discussion and Case Study Review Stephanie Akbari MD FACS Moderator Medical Director Center for Breast Health Virginia Hospital Center Mark A Gittleman MD FACS Medical Director Breast Care Specialists and Advanced Breast Care Imaging Stefan Glück MD PhD Sylvester Professor Miller School of Medicine University of Miami James V Pellicane MD FACS Director Breast Oncology Bon Secours Cancer Institute Jamie Shutter MD Owner South Beach Medical Consultants Hatem Soliman MD Assistant Member Comprehensive Breast Cancer and Experimental Therapeutics Moffitt Cancer Center and Research Institute Seventy five percent of cancer therapies today are ineffective said David Macdonald CEO of Agendia This represents 37 billion dollars spent globally on cancer drugs that do not benefit patients Today s event further demonstrates Agendia s commitment to the continued development of clinically reliable diagnostics that provide doctors with decision making tools needed to improve the effectiveness of cancer therapies for their patients 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

    Original URL path: http://www.agendia.com/agendia-brings-together-thought-leaders-in-molecular-diagnostics-and-medical-oncology/ (2016-05-01)
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  • 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. | Agendia
    to receive 6 cycles of docetaxel 75 mg m 2 doxorubicin 50 mg m 2 cyclophosphamide 500 mg m 2 TAC Arm A versus A 60 mg m 2 and C 600 mg m 2 given every 2 weeks x 4 followed by 3 weekly doses of carboplatin carbo at an AUC 2 and nab P 100 mg m 2 repeated as 28 day cycles x 3 Arm B Pts with HER2 BC by immunohistochemistry IHC and or FISH received NCT as per Arm B but with trastuzumab trast given weekly with carbo and nab Arm C Core biopsies were taken pre NCT 70 gene MammaPrint profiling for poor vs good risk features and 80 gene profiling for basal HER2 and luminal subtypes were performed We assessed the predictive value of gene profiling for response to NCT as a function of RCB scores of 0 1 vs 1 Results Pre NCT fresh tissue was procured from 97 pts Pts were treated for stage II 49 III locally advanced 51 and IBC 16 BC 57 of BCs were ER and or PR and 36 were HER2 by IHC or FISH RCB scores were available in 90 of pts enrolled 10 is awaiting surgery scores of 0 1 were observed in 29 pts treated on either Arms A or B and in 64 of pts treated on Arm C There was 98 concordance of HER2 BCs by IHC FISH vs gene profiling 35 of HER2 BCs by IHC FISH were HER2 by gene profiling Of the 25 pts with response data on Arm C 8 of 19 pts who were HER2 by both IHC FISH and HER2 gene profiling achieved pCR RCB 0 vs 2 of 6 pts with HER2 BC by IHC FISH but with HER2 gene profiles p value 0

    Original URL path: http://www.agendia.com/gene-signatures-as-predictors-of-response-to-neoadjuvant-chemotherapy-with-docetaxel-doxrubicin-cyclophosphamide-tac-or-ac-and-nab-paclitaxel-and-carboplatin-trastuzumab-in-patients-with-stag/ (2016-05-01)
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  • Agendia Presents Broad Array of Predictive and Prognostic Studies on Breast and Colorectal Cancers at ASCO 2010 Annual Meeting | Agendia
    L Vora S Lau T H Luu L Kruper J Yim Y Yen F de Snoo R A Bender Time 2 00 PM 6 00 PM Location S Hall A2 Date Saturday June 5 2010 POSTER PRESENTATION Abstract 561 Evaluation of the 70 gene prognosis MammaPrint signature for the prediction of prognosis of breast cancer independently from histologic grade M Knauer E J Rutgers S Mook J Wesseling L J van t Veer Time 2 00 PM 6 00 PM Location S Hall A2 Date Monday June 7 2010 POSTER DISCUSSION Abstract 1520 Effect of screening on the detection of good and poor prognosis breast cancers Y Shieh L Esserman E J Rutgers M Knauer V Retel S Mook A Glas S C Linn F E van Leeuwen L van t Veer Time 2 00 PM 6 00 PM 5 00 PM 6 00 PM discussion in E451b Location E450b Colon Cancer Date Monday June 7 2010 POSTER PRESENTATION Abstract TPS199 The PARSC trial a prospective study for the assessment of recurrence risk in stage II colon cancer CC patients using ColoPrint R Salazar J Marshall L Stork Sloots I Simon M Lutke Holzik J Tabernero J J Van Der Hoeven F Bibeau R Rosenberg Time 8 00 AM 12 00 PM Location S Hall A2 Date Tuesday June 8 2010 POSTER DISCUSSION Abstract 3513 I ndependent validation of a prognostic genomic profile ColoPrint for stage II colon cancer CC patients R Rosenberg M Maak U Nitsche T Schuster B Kuenzli M Snel I Simon K Janssen H Friess Time 11 00 AM 12 00 PM Location S 406 Vista Room About MammaPrint MammaPrint is the first and only breast cancer recurrence test cleared by the U S Food and Drug Administration FDA FDA clearance under the in vitro diagnostic

    Original URL path: http://www.agendia.com/agendia-presents-broad-array-of-predictive-and-prognostic-studies-on-breast-and-colorectal-cancers-at-asco-2010-annual-meeting/ (2016-05-01)
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  • News and Press Releases | Agendia - Part 3
    ongoing study Continued Agendia Receives New FDA Clearance for MammaPrint FFPE Breast Cancer Test 02 10 2015 FDA Decision Covers Use of MammaPrint in FFPE for the 70 Gene Breast Cancer Recurrence Assay IRVINE CA and AMSTERDAM THE NETHERLANDS Agendia a leading molecular diagnostics company that develops and markets genomic diagnostic products announced that it has received 510 k Continued Agendia s MammaPrint and BluePrint Tests to Be Highlighted at San Antonio Breast Cancer Symposium 12 08 2014 Expert Symposium Panel Will Offer Insights Into How Functional Molecular Subtypes Can Better Individualize Treatment IRVINE CA and AMSTERDAM THE NETHERLANDS New breast cancer research on Agendia s MammaPrint and BluePrint genomic tests will be presented in scientific posters at the Continued Agendia Breast Cancer Test for Molecular Subtyping Improves Match of Therapy to Patient Study Finds 10 09 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 10 02 2014 IRVINE CA and AMSTERDAM

    Original URL path: http://www.agendia.com/agendia-news-and-press-releases/page/3/ (2016-05-01)
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  • Published Study Validates Agendia’s MammaPrint Test for Long-Term Prediction of Breast Cancer Outcome | Agendia
    DMFS and overall survival The accuracy of MammaPrint results held true for both DMFS and overall survival regardless of whether patients had node negative or node positive cancer The data was generated from a group of consecutively treated women who were originally diagnosed between 1984 and 1995 and were less than 53 years of age at diagnosis Median follow up on these patients was 18 5 years far longer than has previously been reported for a test of this kind with a range of 15 to 25 years These findings address a significant concern for physicians who treat patients according to the results of gene signatures like the 70 gene test as to the long term consequences of their treatment said Stefan Glück M D Ph D This study provides the first conclusive evidence that a genomic test can accurately stratify patients recurrence risk for many years after their breast cancer is first discovered Dr Glück is a medical oncologist with a specific focus on breast cancer and 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 Miami FL MammaPrint is the fastest growing risk recurrence assay for breast cancer and uniquely provides definitive High Risk or Low Risk information without ambiguous intermediate results The test is the first FDA cleared assay of its kind and the only one that is backed by peer reviewed prospective outcome data e g the RASTER study MammaPrint is performed as part of the Symphony test panel which also includes the BluePrint assay the most widely available test providing molecular subtyping of individual breast cancers This remarkable long term study demonstrates the ability of the 70 gene signature to accurately differentiate higher risk from lower risk women with regard to risk of recurrence and overall survival at a time in their lives when breast cancer can have its most devastating impact on fertility productivity and capacity to fulfill childrearing responsibilities said Agendia s Chief Medical Officer oncologist Neil Barth M D The data show MammaPrint retains its accuracy to classify the intrinsic long term biology of a patient s cancer This accuracy persists regardless of changes that have occurred over time such as earlier patient diagnosis expanded treatment options and improved efficacy of therapy The study provides oncologists and their patients with an extra measure of confidence that the results of the test will remain accurate for many years forward 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 by analyzing the complete human genome and identifying the most relevant genes to ensure definitive no intermediate results Symphony includes MammaPrint the first FDA cleared IVDMIA breast cancer recurrence assay and the only one backed by prospective outcome data as well as BluePrint a molecular subtyping assay and TargetPrint an ER

    Original URL path: http://www.agendia.com/published-study-validates-agendias-mammaprint-test-for-long-term-prediction-of-breast-cancer-outcome/ (2016-05-01)
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  • African-American Women More Likely to Be Diagnosed with Higher Risk Breast Cancer | Agendia
    a higher risk of recurrence A companion BluePrint test was used to define the specific molecular subtype of each cancer When classified by both genomic tests African American women with stage I to III breast cancer often presented with gene expression subtypes that were less favorable The co author of the research Raquel Nunes MD a medical oncologist at the Washington Cancer Institute presented the data as a scientific poster at the recent American Society of Clinical Oncology annual meeting It s important that research continues to address these issues comprehensively from the biology of the disease to the development of optimal treatment and access to healthcare said Dr Nunes This work is particularly meaningful for us because it complements our interest in health disparities and highlights the enthusiastic participation of African Americans in breast cancer research Unlike genetic tests such as those for BRCA genes which are inherited and look at overall susceptibility for developing breast cancer genomic tests look at the genes inside a breast cancer cell and how strongly they are expressed The findings support prior research that has looked at the biologic characteristics of breast cancer in African American women but this specific methodology reported here was used for the first time in this population Cancer specialists will continue to follow the patients in the research study over the next five years to evaluate their survival with treatment according to their gene profile https www medstarhealth org washington Documents Genomic Profiling Breast Cancer pdf MedStar Washington Hospital Center is a 926 bed major teaching and research hospital It is the largest private not for profit hospital in the nation s capital among the 50 largest hospitals in the nation and a major referral center for the most complex tertiary services It consistently ranks among the nation

    Original URL path: http://www.agendia.com/african-american-women-more-likely-to-be-diagnosed-with-higher-risk-breast-cancer/ (2016-05-01)
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  • Molecular Subtyping with Agendia Tests Can Provide Better Guidance for Breast Cancer Treatment, New Research Reports | Agendia
    standard measures Dr Whitworth said the BluePrint test more accurately classifies an individual woman s breast cancer compared to conventional IHC FISH pathology tests Armed with that information oncologists and surgeons can better determine the best neoadjuvant treatment depending on the individual patient s molecular subtype The 426 patients in the prospective trial reported by Dr Whitworth were from 50 different centers One of the significant aspects of this study is that it gathers real world outcomes from a broad base of community and academic practices he said Patients in the study are part of the ongoing Neoadjuvant Breast Registry Symphony Trial study NBRST Researchers looked at how IHC FISH and MammaPrint BluePrint classified each patient s subtype They then examined how patients responded to neoadjuvant chemotherapy or endocrine treatment to see whether IHC FISH or MammaPrint BluePrint was better at predicting response to neoadjuvant therapy Overall BluePrint reclassified 22 of tumors in the study The demonstrated benefits of MammaPrint BluePrint can in turn help guide oncologists and surgeons in the future as they consider whether to propose neoadjuvant treatment and what kind of treatment typically chemotherapy or endocrine therapy to recommend Genomic tests such as MammaPrint and BluePrint are part of the revolution in personalized medicine Genomic tests examine the activity of groups of genes within a cancer tumor to provide a more comprehensive view of the cancer and treatment options The MammaPrint test predicts how likely it is that a woman s breast cancer will recur BluePrint then identifies the molecular subtype of her cancer and predicts tumor response to targeted therapies before and after surgery The four molecular subtypes are known as Luminal A Luminal B Basal type and HER2 type In the separate poster Dr Yao and colleagues reported that MammaPrint accurately predicts an individual patient s risk of local regional recurrence in stage 1 through 2b breast cancer upon original diagnosis The poster also said MammaPrint could help define patients that would benefit from more comprehensive treatment nodal irradiation tumor bed boost or that may be safely treated with a targeted approach partial breast irradiation or IORT Yao and colleagues at NorthShore University Health System Chicago and Fox Chase Cancer Center and Thomas Jefferson University Hospital Philadelphia analyzed the recurrence rate in 374 patient tumor samples Their data had a median follow up of 8 3 years The American Society of Breast Surgeons annual meeting was held in Las Vegas on April 30 May 4 2014 Resources for further reference RASTER prospective outcome study and press release MammaPrint valid up to 25 years study and press release Molecular subtyping study 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 Symphony breast cancer suite was 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

    Original URL path: http://www.agendia.com/molecular-subtyping-with-agendia-tests-can-provide-better-guidance-for-breast-cancer-treatment-new-research-reports/ (2016-05-01)
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