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  • Agendia Co-Founder Awarded EU Prize for Women Innovators | Agendia
    by peer reviewed prospective outcome data Among the consequences of this innovation and Dr van t Veer s work Overtreatment by chemotherapy may be reduced by up to 30 without jeopardizing patients survival Women who can safely forego chemotherapy also avoid its side effects which can be debilitating and sometimes lead to permanent damage such as heart failure or impaired cognition MammaPrint s ability to identify women who are at low risk of recurrence means that payers no longer have to cover the high cost of chemotherapy when it is unnecessary thereby reducing overall healthcare costs Dr van t Veer is now the Breast Oncology Program Leader and Professor of Laboratory Medicine at the University of California San Francisco Her current research focuses on the molecular basis for early response to therapy to guide the development of therapy specific companion diagnostics Dr van t Veer and the two other winners were selected by an independent panel of experts from a total of 67 applications Saskia Biskup M D Ph D Germany first prize and Ana Maiques M S Spain third prize were the other two winners Although the proportion of female researchers in Europe is increasing the under representation of women in scientific disciplines and careers persists Women represent only 33 of European researchers 20 of full professors and 15 5 of heads of institutions in higher education according to the European Commission Despite some advances in recent years women in research remain a minority This is a waste of talent that we cannot afford said Máire Geoghegan Quinn European Commissioner for Research Innovation and Science We have to foster gender equality in the research landscape but also raise the profile of successful women innovators This prize does exactly that The EU s Innovation Convention is considered Europe s foremost innovation event and was attended by leading visionaries researchers business leaders and policymakers from around the world We are extremely proud of Dr van t Veer and congratulate her on gaining this prestigious international recognition said David Macdonald Agendia s CEO This award demonstrates the importance of her contribution to breast cancer care to women now and in the future and to more sensible healthcare economics It is an honor for all of us at Agendia to support and carry on Dr van t Veer s remarkable accomplishments MammaPrint the first FDA cleared test of its kind provides definitive High Risk or Low Risk information about breast cancer recurrence for determining the appropriateness of chemotherapy for each individual patient Unlike other genomic tests for breast cancer the test has no ambiguous intermediate results It is also the fastest growing risk recurrence assay for breast cancer and the only one providing risk recurrence information that is based on prospective trials including peer reviewed patient outcome data the RASTER study MammaPrint is part of Agendia s Symphony test panel The Agendia tests have substantial insurance coverage encompassing an estimated 182 million lives and including coverage by Medicare and regional and national insurers

    Original URL path: http://www.agendia.com/agendia-co-founder-awarded-eu-prize-for-women-innovators-2/ (2016-05-01)
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  • Agendia’s BluePrint Molecular Subtyping Assay Highlighted at the 32nd Annual Miami Breast Cancer Conference | Agendia
    respond to neoadjuvant chemotherapy by reclassifying up to 22 of tumors and also helps suggest the best course for therapy said Whitworth One implication of the study findings is that we will eventually end up evaluating and treating many breast cancer patients differently than we do now because we will rely on their functional molecular subtype rather than just IHC FISH pathology results Interim results on the first 426 patients of the study were published in October 2014 by the Annals of Surgical Oncology This analysis found the pCR rate by functional molecular subtype classified HER2 type patients was 53 and was significantly superior to the 38 pCR rate in IHC FISH HER2 patients p 0 047 Details available here Agendia s BluePrint 80 gene Molecular Subtyping Assay is the most widely available test providing the functional molecular subtype of a woman s breast cancer BluePrint is performed on formalin fixed paraffin embedded FFPE tissue and is part of Agendia s suite of breast cancer assays that also includes the MammaPrint 70 gene Risk of Recurrence assay which recently 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 Physicians and their patients typically rely on a number of factors when selecting the best course of therapy Agendia s suite of breast cancer recurrence assays fundamentally changes that conversation at that critical point where treatment decisions are being made said Jan Egberts M D CEO of Agendia While MammaPrint test results eliminate the ambiguity of the Intermediate result seen in up to 39 of other tests molecular subtyping by BluePrint provides greater insight into the biology of the tumor that just isn t available from most of the other breast cancer recurrence assays on the market MammaPrint has substantial insurance coverage including Medicare regional and national insurers encompassing an estimated 200 million lives in the U S The 32 nd annual Miami Breast Cancer Conference took place Feb 27 March 1 2015 at the Fontainebleau Hotel in Miami Beach FL 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 biology and TargetPrint an ER PR HER2 expression assay MammaPrint is the only breast cancer recurrence assay supported by peer reviewed published prospective outcome data These tests can

    Original URL path: http://www.agendia.com/agendias-blueprint-molecular-subtyping-assay-highlighted-at-the-32nd-annual-miami-breast-cancer-conference/ (2016-05-01)
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  • Agendia’s MammaPrint and BluePrint Tests to Be Highlighted at San Antonio Breast Cancer Symposium | Agendia
    predictive biomarker of response to veliparib carboplatin plus standard neoadjuvant therapy in high risk breast cancer results from the I SPY 2 TRIAL Authors D M Wolf Ch Yau A Sanil A Daemen L Heiser J Gray L Brown Swigart S Flynn G Hirst I SPY 2 TRIAL Investigators M Buxton A DeMichele N Hylton F Symmans D Yee M Paoloni L Esserman D Berry H Rugo O Olapade L van t Veer Exhibit Halls A B Time 5 00 7 00 p m P3 06 37 I SPY 2 Qualifying Biomarker Evaluation QBE The Challenge and Opportunity for Interrogating Predicted Pathways in an Adaptive Design Biomarker Rich Trial Authors C Yau D Wolf A Sanil L van t Veer E F Petricoin M Buxton J Gray A DeMichele M Hogarth N Hylton J Perlmutter M Paoloni F Symmans D Yee D Berry L Esserman Exhibit Halls A B Time 5 00 7 00 pm Friday December 12 2014 Poster P4 11 08 Pathological assessment of discordant cases for molecular BluePrint and MammaPrint vs clinical subtypes for breast cancer among 6 694 patients from the EORTC 10041 BIG 3 04 MINDACT trial Authors Giuseppe Viale Leen Slaets Femke de Snoo Jan Bogaerts Laura J van t Veer Emiel J Rutgers Martine J Piccart Gebhart Jeroen van den Akker Lisette Stork Sloots Leila Russo Patrizia Dell Orto Fatima Cardoso on behalf of the TRANSBIG Consortium the MINDACT investigators Exhibit Halls A B Time 7 30 9 00 am Poster OT3 3 01 PROMIS PRospective study Of MammaPrint in breast cancer patients with an Intermediate recurrence Score PROMIS Authors Hatem Soliman Sarah Untch Lisette Stork Sloots Exhibit Halls A B Time 5 00 7 00 pm Poster OT3 2 02 MINT I Multi Institutional Neo adjuvant Therapy MammaPrint Project I Authors C C Cox P Blumencranz R Saez R Wesolowski W Dooley L Stork Sloots F de Snoo S Untch E Avisar Exhibit Halls A B Time 5 00 7 00 pm Saturday December 13 2014 Poster P6 08 22 Functional subtyping with BluePrint 80 gene profile identifies two distinct triple positive subtypes with and without trastuzumab chemo sensitivity Implications for treatment from the NBRST registry Authors Pat Whitworth Jennifer Beatty Paul Baron Paul Richards James V Pellicane Angela Mislowsky Charles Nash Laura A Lee Mary Murray Femke de Snoo Lisette Stork Sloots Sarah Untch Mark Gittleman Stephanie Akbari Peter Beitsch Exhibit Hall C Time 7 30 9 00 am MammaPrint is the first FDA cleared test to determine recurrence risk in breast cancer patients The Agendia tests have substantial insurance coverage encompassing an estimated 200 million lives including coverage by Medicare and regional and national insurers The 70 gene MammaPrint test a second generation breast cancer recurrence assay provides definitive High Risk or Low Risk information about breast cancer recurrence with no intermediate results Agendia s companion BluePrint test is the only widely available assay that provides functional molecular subtypes It provides enhanced information about which patients may or may not

    Original URL path: http://www.agendia.com/agendias-mammaprint-and-blueprint-tests-to-be-highlighted-at-san-antonio-breast-cancer-symposium/ (2016-05-01)
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  • Agendia Breast Cancer Test for Molecular Subtyping Improves Match of Therapy to Patient, Study Finds | Agendia
    we do now because we will rely on their molecular subtype rather than just IHC FISH pathology results The study was selected for poster discussion at ESMO and the results were discussed by Dr Suzette Delaloge a medical oncologist at the Institut de Cancérologie Gustave Roussy in Villejuif France She explained the results and termed the findings very interesting Agendia s 70 gene genomic test MammaPrint provides the foundational risk classification of High Risk or Low Risk about breast cancer recurrence without the ambiguity of intermediate results Additional therapy predictive information is then conferred by BluePrint which identifies the molecular subtype An earlier iteration of the study that was featured in the poster at ESMO was recently published by the Annals of Surgical Oncology as part of the ongoing Neoadjuvant Breast Registry Symphony Trial NBRST pronounced N breast with details available here The ESMO conference also included a scientific poster on a study from Spain that prospectively documented the ability of tests such as Agendia s MammaPrint to safely exempt some breast cancer patients from chemotherapy The poster confirmed the power of the MammaPrint test to change physicians recommendations about the best way to treat breast cancer after surgery In the Spanish study the MammaPrint test was performed on tumor tissue from 150 node negative ER positive patients who were served by community based practices in Valencia Spain Researchers reported MammaPrint changed the initial treatment recommendation in 63 4 of relevant patients The overall conclusions about MammaPrint are similar to those in a prospective outcome based study that appeared in the International Journal of Cancer RASTER study The poster noted that use of an assay such as MammaPrint can be valuable in reducing the total number of patients receiving chemotherapy after breast cancer surgery thus preventing major toxicity and inconvenience to patients and saving costs Eduardo Martinez de Duenas M D was lead author on the poster Among the co authors was Antonio Llombart M D A separate program moderated at the ESMO meeting by Dr Llombart highlighted both the process of evaluating breast cancer risk of recurrence and the significance of functional molecular subtypes Dr Llombart is head of the Medical Oncology Department of the Hospital Arnau de Vilanova in Valencia Spain and is also Chairman of SOLTI and Coordinator of the SOLTI Scientific Committee SOLTI is a non profit cooperative research group that performs clinical trials of excellence in oncology The ESMO 2014 meeting held 26 30 September drew 19 000 plus participants from 120 countries a 23 increase in participants from the last such ESMO meeting Resources for further reference Independent comparison validates molecular subtyping includes video RASTER prospective outcome study MammaPrint valid up to 25 years study and press release 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 breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome MammaPrint

    Original URL path: http://www.agendia.com/agendia-breast-cancer-test-for-molecular-subtyping-improves-match-of-therapy-to-patient-study-finds/ (2016-05-01)
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  • Agendia Board of Directors Appoints Jan Egberts, M.D., as CEO | Agendia
    to further serve Agendia s growing number of physician customers their patients and my fellow shareholders Dr Egberts said I m firmly committed to leading the company and 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 Dr Egberts noted that Agendia s molecular diagnostic technology for breast cancer has recently been featured in a number of prominent scientific studies journal articles and peer reviewed presentations including Publication of a large multi site study in the Annals of Surgical Oncology validating the MammaPrint and BluePrint tests ability to identify molecular subtypes and better guide preoperative treatment Presentation of the first independent study to document how MammaPrint and BluePrint together eliminate the uncertainty of intermediate results for risk of breast cancer recurrence an uncertainty that is inherent in competing technologies Progress in the I SPY 2 clinical trial involving the US FDA NIH leading academic cancer centers and pharmaceutical companies for which MammaPrint was selected the biomarker of choice Having achieved these recent milestones Agendia is well positioned to continue its growth trajectory and provide a highly accurate and actionable molecular diagnostics platform for the oncology community and other stakeholders Dr Egberts said 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 FDA cleared 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 MammaPrint

    Original URL path: http://www.agendia.com/agendia-board-of-directors-appoints-jan-egberts-m-d-as-ceo/ (2016-05-01)
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  • Agendia Test for Molecular Subtyping of Breast Cancer Is a Better Guide to Pre-Surgical Treatment, Study Finds | Agendia
    evaluating and treating many breast cancer patients differently than we do now because we will rely on their molecular subtype rather than just IHC FISH pathology results More information and updated data from this ongoing study will also be presented at the European Society for Medical Oncology ESMO 2014 Congress in a poster discussion ESMO 2014 will be held Sept 26 30 in Madrid An earlier iteration of the study encompassing 426 patients was recently published by the Annals of Surgical Oncology as part of the ongoing Neoadjuvant Breast Registry Symphony Trial NBRST pronounced N breast with details available here The researchers findings will also be published in the October print edition of the Annals of Surgical Oncology The BluePrint test is performed in conjunction with Agendia s 70 gene MammaPrint test MammaPrint provides the foundational risk classification of High Risk or Low Risk about breast cancer recurrence without the ambiguity of intermediate results Additional therapy predictive information is then conferred by the 80 gene BluePrint assay which identifies the molecular subtype This study is telling us that we now have a better tool to measure the dominant biological drivers of each individual breast cancer said Neil Barth MD an oncologist and Agendia s Chief Medical Officer I n addition to Dr Whitworth s Nashville Breast Center the multi site study drew patients from a broad base of community and academic practices including hospitals in Washington D C Dallas Virginia Pennsylvania and Georgia Resources for further reference Independent comparison validates molecular subtyping includes video RASTER prospective outcome study and press release MammaPrint valid up to 25 years study and press release 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

    Original URL path: http://www.agendia.com/agendia-test-for-molecular-subtyping-of-breast-cancer-is-a-better-guide-to-pre-surgical-treatment-study-finds/ (2016-05-01)
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  • Agendia Announces Study Showing Molecular Subtyping Can Improve Breast Cancer Treatment | Agendia
    such as IHC and FISH to generate clinical decisions he said But we have also recognized these pathology tests are not complete as we have often seen discordance between what we were told by IHC FISH and how the cancer actually behaved He said the new study combined with other recent research is telling us that we now have a better tool to measure the dominant biological drivers of each individual breast cancer He likened this next iterative step in understanding breast cancer to moving from having a cell phone to having a smart phone With molecular subtyping we now have something akin to a smart phone s GPS to help us better determine where we are and where we can go he said The new study also confirmed published research from Stefan Gluck M D that preoperative chemotherapy given to patients with the common Luminal A subtype of cancer generally has little benefit The BluePrint test takes a much more nuanced look at breast cancer biology than is available from IHC FISH tests said Dr Whitworth This new information about luminal cancers is one example of how molecular subtyping may help guide preoperative treatment decisions Dr Whitworth said that research into molecular subtypes if confirmed by other research may also change the treatment of triple positive breast cancers those that are reported as HER2 ER and PR positive by IHC FISH testing According to this new research about half of these patients do not exhibit HER 2 type responses and may therefore respond better to a different treatment than would be given to a HER2 positive patient he said The potential benefits of neoadjuvant cancer treatment are emphasized by the American College of Surgeons Commission on Cancer Despite its known advantages many people are not provided the advantages of pre surgical therapy notes a commission statement The commission also advises physicians and patients as follows Don t use surgery as the initial treatment without considering pre surgical neoadjuvant systemic and or radiation for cancer types and stage where it is effective at improving local cancer control quality of life or survival Among Dr Whitworth s patients in the Annals of Surgical Oncology study was Kara Sanders who at the time of diagnosis was a federal probation officer in her late thirties She was among patients whose cancer was reclassified by MammaPrint and BluePrint after it had been analyzed by IHC FISH as being triple positive Guided in part by the genomic tests her neoadjuvant treatment was successful in achieving a pathologic complete response the absence of invasive carcinoma in the breast and axilla prior to surgery After my diagnosis I couldn t find a lot of information about breast cancer in premeopausal women Sanders said I was very happy to be part of the trial to contribute to the research because it s very empowering to have more knowledge of this kind In addition to Dr Whitworth s Nashville Breast Center the multi site study drew patients from a

    Original URL path: http://www.agendia.com/agendia-announces-study-showing-molecular-subtyping-can-improve-breast-cancer-treatment/ (2016-05-01)
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  • Agendia Co-Founder and CSO Develops Method to Identify Women Who Will Benefit from Tamoxifen Therapy for Breast Cancer | Agendia
    less common risks include endometrial cancer and blood clots Roughly half of women who begin tamoxifen therapy do not complete the full course of treatment Breast cancer patient Lisa Hill remembers closing in on the finish line of five years with tamoxifen I was planning a party to celebrate the end of my aches pains and weight gain Hill said when her oncologist told her new studies showed women should stay on the drug for ten years Dr Bernards research draws upon next generation technologies that have proven so valuable to specialists who want to offer their patients the very best treatment for breast cancer said Neil Barth M D the Chief Medical Officer at Agendia This new line of research has the potential to expand clinicians ability to identify which treatments will be most beneficial It may also enable them to suggest alternatives to tamoxifen treatment when it is not likely to be effective In their study Bernards and colleagues identified and tested a gene signature that is associated with the loss of function of a gene called USP9X When USP9X loses function in breast cancer cells they concluded it results in tamoxifen resistance We showed that this gene signature was able to identify tamoxifen resistant patients in two large cohorts said Bernards We are now working to validate these promising results using data from a prospective randomized controlled trial and we expect to complete this process by the end of the year If this is successful clinical implementation is a logical next step Bernards co founded Agendia Inc in 2003 He is head of Molecular Carcinogenesis at the Netherlands Cancer Institute at Antoni van Leeuwenhoek Hospital and a part time professor at Utrecht University His study was funded by the Dutch Cancer Society About Agendia Agendia is a

    Original URL path: http://www.agendia.com/agendia-co-founder-and-cso-develops-method-to-identify-women-who-will-benefit-from-tamoxifen-therapy-for-breast-cancer/ (2016-05-01)
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