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  • Independent validation of a prognostic genomic profile (ColoPrint) for stage II colon cancer (CC) patients | Agendia
    high risk patients and can assist in treatment decisions Methods An 18 gene profile had been developed using gene expression data from whole genome Agilent 44K oligonucleotide arrays and was validated in samples from an independent cohort of 206 CC patients and in in silico datasets Salazar et al JCO 2010 in press The profile was translated into a robust diagnostic test ColoPrint using customized 8 pack arrays For this study 233 patients who underwent curative resection R0 for colon cancer stages II or III at the Klinikum rechts der Isar from 1987 to 2003 were selected Fresh frozen tissues clinical parameters and follow up data for all patients were available The samples were hybridized and the ColoPrint index was determined for all samples blinded from the clinical data Results Patients in this study had a median age of 64 years and median follow up of 97 months The median number of resected lymph nodes was 21 giving an indirect measure of the quality of surgery In the 135 stage II patients ColoPrint identified most patients 73 as low risk The 5 year distant metastasis free survival was 95 for low risk patients and 80 for high risk patients In the univariate analysis ColoPrint was the only significant parameter to predict the development of distant metastasis with a HR of 4 1 95 CI 1 31 13 01 p 0 009 Using clinical parameters from the ASCO recommendation T4 perforation less than 12 LN assessed and or high grade for the identification of high risk patients was not significant HR 2 3 95 CI 0 68 7 53 p 0 18 and did not add power to the ColoPrint classification These results are in good agreement with results from the first independent validation Conclusions ColoPrint is able to predict the

    Original URL path: http://www.agendia.com/independent-validation-of-a-prognostic-genomic-profile-coloprint-for-stage-ii-colon-cancer-cc-patients/ (2016-05-01)
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  • Agendia’s MammaPrint and BluePrint Breast Cancer Tests to Be Highlighted at San Antonio Symposium | Agendia
    prospective NBRST study NBRST Authors James V Pellicane Pat Whitworth Peter Beitsch Paul Baron Jennifer Beatty Mary Murray Carrie L Dul Angela M Mislowsky Charles H Nash Paul D Richards Laura A Lee Lisette Stork Sloots Femke de Snoo Sarah Untch Mark Gittleman Stephanie Akbari Michael C Rotkis Exhibit Halls A B Time 5 00 p m 7 00 p m Poster OT2 03 01 Measuring the Impact of MammaPrint on treatment in Breast Cancer Patients A Prospective Registry IMPaCt Authors Lowell L Hart Sarah Untch Lisette Stork Sloots Exhibit Halls A B Time 5 00 p m 7 00 p m Friday December 11 Poster P4 14 10 Pertuzumab overcomes chemotherapy trastuzumab resistance in ER Her2 tumors classified as Luminal functional subtype by the 80 gene BluePrint assay in the prospective Neo adjuvant Breast Registry Symphony Trial NBRST Authors Peter Beitsch Pat Whitworth Paul Baron Jennifer Beatty James V Pellicane Mary K Murray Carrie L Dul Angela M Mislowsky Charles H Nash Paul D Richards Laura A Lee Lisette Stork Sloots Femke de Snoo Sarah Untch Mark Gittleman Stephanie Akbari Michael C Rotkis Exhibit Halls A B Time 7 30 a m 9 00 a m Poster P4 14 29 One third of HER2 positive patients have 80 gene Luminal subtype that is resistant to Chemo trastuzumab but sensitive to Chemo trastuzumab pertuzumab critical implications for the adjuvant setting from the NBRST neoadjuvant registry NBRST Authors Peter Beitsch Pat Whitworth Paul Baron Jennifer Beatty James V Pellicane Mary K Murray Carrie L Dul Angela M Mislowsky Charles H Nash Paul D Richards Laura A Lee Lisette Stork Sloots Femke de Snoo Sarah Untch Mark Gittleman Stephanie Akbari Michael C Rotkis Exhibit Halls A B Time 7 30 a m 9 00 a m Poster P5 13 07 An Investigator Initiated Registry Trial of Simple Oral Therapy for Low Risk Breast Cancer FHCRC Authors VK Gadi Courtney Preusse Kristine Calhoun Janice Kim Hannah Linden Mara Rendi Ruth Etzioni Ted Gooley Gary Lyman Lisette Stork Vastiaan van der Baan Neil Barth Habib Rahbar Exhibit Halls A B Time 5 00 p m 7 00 p m Saturday December 12 Poster P6 05 07 Improving personalized management of primary breast cancer Mammaprint Risk stratification and Blueprint molecular subtyping Authors Lekha Mikkilineni Laura K Austin Kimberly Limentani Rebecca J Jaslow Tiffany P Avery Juan Palazzo and Massimo Cristofanilli Exhibit Halls A B Time 7 30 a m 9 00 a m Poster P6 08 06 Neoadjuvant tamoxifen therapy synchronizes ERα binding and gene expression profiles AFTER Authors Sabine C Linn Tesa M Severson Ekaterina Nevedomskaya Justine Peeters Annelot van Rossum Thomas Kuilman Oscar Krijgsman Ines Goossens Annuska Glas Rutger Koornstra Daniel Peeper Jelle Wesseling Iris M Simon Lodewyk Wessels Wilbert Zwart Exhibit Halls A B Time 7 30 a m 9 00 a m Poster P6 09 01 Identification of tumors with an indolent disease course MammaPrint Ultralow signature validation in a retrospective analysis of a Swedish randomized tamoxifen trial STO Authors Laura

    Original URL path: http://www.agendia.com/agendias-mammaprint-and-blueprint-breast-cancer-tests-to-be-highlighted-at-san-antonio-symposium/ (2016-05-01)
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  • Agendia Highlights Study Showing MammaPrint/BluePrint Tests Predict Response to Current Breast Cancer Chemotherapy and Targeted Therapy Regimens | Agendia
    a group not nearly as well as HER2 positive and ER negative patients There is a subgroup of HER2 positive ER positive patients whose cancers do not respond favorably to that standard treatment These new findings indicate the tumors in this subgroup are in fact Luminal type not HER type molecular subtype as assessed by BluePrint For better survival this group of patients may require dual drug treatment that combines pertuzumab with chemotherapy and trastuzumab Agendia CEO Mark Straley underscored the significance of the research These findings are further evidence that Agendia s research and development place us in a unique position to work with pharmaceutical companies to better understand breast cancer biology and to refine treatment by predicting response Straley said Predicting which patients will benefit the most from costly and potentially toxic therapies and which patients can safely forego them is a critically important part of improving breast cancer care Agendia s assays continue to demonstrate that they can help physicians make the most personalized and most current predictive treatment decisions for each breast cancer patient Among the findings presented in Dr Beitsch s talk were these MammaPrint BluePrint reclassified 23 of patients and yielded significantly better correlation with both neoadjuvant chemotherapy responsiveness and resistance compared to IHC FISH MammaPrint BluePrint subtyping divided triple positive HER2 ER HR cancers into Luminal type and HER2 type molecular subtypes of approximately equal proportion Triple positive BluePrint Luminal type cancers are relatively resistant to NCT trastuzumab Perjeta added to NCT trastuzumab overcomes this resistance We believe this data is the first prospectively gathered evidence of its kind said Dr Beitsch It provides further evidence for the substantial value of functional molecular subtyping and its utility in predicting which patients will require dual neoadjuvant drug therapy combining trastuzumab and pertuzumab Agendia s MammaPrint 70 gene assay and BluePrint 80 gene molecular subtyping assay are the most widely available tests that provide the functional molecular subtype of a woman s breast cancer Molecular subtyping is a form of precision medicine increasingly used to personalize treatment It allows physicians to more accurately understand the biology of a woman s breast cancer and better allocate treatment that fits her particular cancer The MammaPrint 70 gene assay has received FDA 510 k clearance for use in FFPE tissue samples MammaPrint was the first breast cancer risk of recurrence multi gene assay to receive FDA 510 k clearance With the most recent clearance Agendia now has six FDA clearances in its breast cancer portfolio Among the study co authors were Pat Whitworth M D a surgical oncologist at Nashville Breast Center and clinicians from 11 other institutions around the U S Dr Beitsch is Director of the Dallas Breast Center and practices at North Central Surgical Central Hospital A widely published researcher he is a Fellow of the Society of Surgical Oncology and past President of the American Society of Breast Surgeons The 2015 Breast Cancer Symposium was held Sept 25 27 in San Francisco It was

    Original URL path: http://www.agendia.com/agendia-highlights-study-showing-mammaprintblueprint-tests-predict-response-to-current-breast-cancer-chemotherapy-and-targeted-therapy-regimens/ (2016-05-01)
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  • Agendia Board of Directors Appoints Mark R. Straley as New Chief Executive Officer | Agendia
    diagnostics and laboratory services Most recently he served as President Anatomical Pathology of Thermo Fisher Scientific Waltham Mass Prior to this position he was President and CEO of Metamark Genetics Cambridge Mass a biotech company focusing on the development of prognostic and predictive diagnostic tests for personalized treatment of cancer patients From 2005 until 2010 Straley held positions at Johnson Johnson company Ortho Clinical Diagnostics first as Worldwide Vice President of Marketing and then as Worldwide President I m pleased to be able to serve Agendia s growing number of physician customers and their patients Straley said I m firmly committed to laying the foundation for the next level of success as we expand the sales of MammaPrint BluePrint and our other molecular tests and as we continue to bring the benefits of our tests to patients around the world About Agendia Agendia is a privately owned 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 suite was developed using an unbiased gene selection by analyzing the complete human genome This includes the MammaPrint test which is the only FDA cleared test for women of all ages and which is not limited by estrogen receptor status Furthermore Agendia s suite of tests includes BluePrint which in combination with MammaPrint provides the only commercially available way to predict response to current breast cancer chemotherapy and targeted therapy regimens In addition to MammaPrint and BluePrint which is a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology Agendia also offers TargetPrint an ER PR HER2 expression assay MammaPrint has six FDA clearances and is the only breast cancer recurrence assay backed by peer reviewed prospective outcome data Agendia s tests help

    Original URL path: http://www.agendia.com/agendia-board-of-directors-appoints-mark-r-straley-as-new-chief-executive-officer/ (2016-05-01)
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  • NCCN Breast Cancer Guidelines Acknowledge MammaPrint’s Ability to Predict Prognosis | Agendia
    Low Risk patients 85 of whom did not receive adjuvant chemotherapy had a 97 distant recurrence free interval at five years A growing number of cancer experts recognize the contribution that MammaPrint can make by providing clinically useful information about disease prognosis and risk of recurrence said oncologist Neil Barth M D FACP Agendia s Chief Medical Officer This acknowledgment further supports the emerging realization that accurately establishing a patient s risk of recurrence without the limitations seen with other assays brings significant value to the management of breast cancer patients The specific mention of the RASTER study confirms the relevance of prospective outcome data when the test was used in a real world setting In contrast to other assays with limited or no FDA clearances MammaPrint is the only assay cleared for patients of all ages and is not limited by estrogen receptor status Additionally unlike other assays MammaPrint test results do not require that patients complete five years of endocrine therapy MammaPrint has received six FDA clearances including most recently for use in formalin fixed paraffin embedded FFPE tissue 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 and MammaPrint Agendia is a privately held leading molecular diagnostics company that develops and markets FFPE based genomic diagnostic products which help support physicians with their complex treatment decisions For breast cancer our offerings include MammaPrint as well as BluePrint a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology and TargetPrint an ER PR HER2 expression assay These tests can help physicians assess a patient s individual risk for metastasis that is which patients are more sensitive to chemo hormonal or combination therapy and which patients

    Original URL path: http://www.agendia.com/nccn-breast-cancer-guidelines-acknowledge-mammaprints-ability-to-predict-prognosis/ (2016-05-01)
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  • Agendia Announces Recommendation of MammaPrint in Germany’s AGO Guidelines | Agendia
    result It is part of Agendia s suite of breast cancer assays that also includes the BluePrint 80 gene molecular subtyping assay and TargetPrint a gene expression assay BluePrint provides additional therapy predictive information identifying the functional molecular subtype of breast cancer and the associated tumor response to neoadjuvant therapy Like MammaPrint and TargetPrint BluePrint is performed on FFPE It is the most widely available test that uncovers the functional molecular subtype of a woman s breast cancer Agendia s suite of breast cancer recurrence assays fundamentally changes the conversation at the critical point where treatment decisions are being made said Egberts While MammaPrint test results eliminate the ambiguity of the intermediate result seen in up to 39 of other tests functional molecular subtyping by BluePrint provides greater insight into the tumor biology that just isn t available from most of the other breast cancer recurrence assays on the market MammaPrint is available worldwide and has substantial insurance coverage including Medicare regional and national insurers encompassing an estimated 200 million lives in the U S The 14 th St Gallen International Breast Cancer Conference took place in Vienna Austria March 18 21 2015 Resources for further reference MammaPrint FFPE receives FDA 510 k clearance press release 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 privately held leading molecular diagnostics company that develops and markets FFPE based genomic diagnostic products which help support physicians with their complex treatment decisions Agendia s breast cancer suite was developed using an unbiased gene selection by analyzing the complete human genome Our offerings include the FDA cleared MammaPrint FFPE as well as BluePrint a molecular subtyping assay that provides deeper insight leading to more clinically actionable

    Original URL path: http://www.agendia.com/agendia-announces-recommendation-of-mammaprint-in-germanys-ago-guidelines-at-st-gallen-international-breast-cancer-conference/ (2016-05-01)
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  • MammaPrint® translating research into a diagnostic test, Molecular Diagnostics, The Key Driver in Personalized Cancer Medicine | Agendia
    Denmark Henrik Winther Dako Denmark Pan Stanford Publihing Author s Annuska M Glas Leonie Delahaye and Oscar Krijgsman January 1 2010 Gene expression profiles that provide clinical utility have been developed in the last decade However only a handful are currently available for broad clinical use through commercial enterprises Once a test does enter the clinical setting it is imperative to get the correct answer even under conditions of varying quality of sample input In the transition phase of the development of a commercial available test there are a number of requirements that need to be met In particular for a gene expression microarray test using a multiple gene index as read out a customized array including control systems needs to be designed validated and shown to be reproducible robust accurate and stable over time In addition regulatory approval is needed This chapter describes all important critical steps being met for the implementation of a multi marker microarray MammaPrint as a routine diagnostic tool 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

    Original URL path: http://www.agendia.com/mammaprint-translating-research-into-a-diagnostic-test-molecular-diagnostics-the-key-driver-in-personalized-cancer-medicine/ (2016-05-01)
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  • The future of diagnostic microarrays; bridging the gap between bench and bedside. | Agendia
    The future of diagnostic microarrays bridging the gap between bench and bedside Publication Name Bioanalysis Author s Roepman Paul January 1 2010 During the last two decades an increasing number of microarray studies have identified gene expression profiles that link disease characteristics to patient outcome However despite improvements in technology and the clinical relevance of the identified profiles only a handful of microarray tests are currently available for clinical use So why have microarrays regardless of the great application and success within a research setting not yet been embraced for routine diagnostic use Besides the strengths of microarray diagnostics this perspective will outline the important challenges that need to be considered for successful translation of a gene profile into a routine diagnostic test Finally some new microarray technologies will be reviewed and an outlook for the future of diagnostic microarrays will be presented 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

    Original URL path: http://www.agendia.com/the-future-of-diagnostic-microarrays-bridging-the-gap-between-bench-and-bedside/ (2016-05-01)
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