Amsterdam, Netherlands
Amsterdam, Netherlands
SEARCH FILTERS
Time filter
Source Type

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that Blue Shield of California has updated its Medical Policy 2.04.36 Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer, to include coverage of the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test. The updated policy states: “The use of MammaPrint is considered medically necessary in women who are diagnosed with primary invasive breast cancer.” “In the treatment of early-stage breast cancer, access to proven, objective and trusted genomic information is invaluable in enabling physicians to confidently personalize treatment decisions for their patients,” said Mark R. Straley, CEO of Agendia. “It is estimated that almost 28,000 women in California will be diagnosed with breast cancer this year.1 The decision by Blue Shield of California to include MammaPrint in their coverage recognizes the benefits of this test in identifying those patients who could safely forgo chemotherapy, and the highest level of clinical evidence that supports it. We are looking forward to ensuring that even more women in California can now receive the increased clarity that MammaPrint can bring at a time that is often fraught with uncertainty.” The revised coverage became effective in the state on 1 June 2017 and Agendia Inc. is now a Preferred Network Provider. This determination follows the peer-reviewed publication of the prospective, controlled and randomized Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) trial in the prestigious New England Journal of Medicine (NEJM)2 in August 2016, which provided the highest level of clinical evidence to support the clinical utility of MammaPrint. The inclusion in Blue Shield of California’s coverage follows a revision from First Coast Service Options, the Medicare contractor for Florida, Puerto Rico and the Virgin Islands to include MammaPrint in its Local Coverage Determination in March 2017. MammaPrint is available globally through many major hospitals, providing physicians and patients access to this essential breast cancer test to enable more informed decision-making and more individualized treatment. More information can be found at www.blueshieldca.com/provider. 2 Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29. MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis within 5 years. MammaPrint also carries the CE Mark which certifies that the test complies with the quality standards set by the European In Vitro Diagnostic Directive, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy. Agendia is a privately held, leading molecular diagnostics company that develops and markets 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. Our offerings include MammaPrint®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint®, a Molecular Subtyping Assay that provides deeper insight leading to more clinically actionable breast cancer biology. In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.


News Article | June 2, 2017
Site: www.businesswire.com

SANTA CLARA, Calif. & IRVINE, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) and Agendia, Inc. today jointly announced an agreement to expand their relationship to include the development of an RNA-Seq kit version of Agendia’s currently marketed MammaPrint and BluePrint tests. Agendia’s MammaPrint test provides High-Risk or Low-Risk test results to assess the risk of distant metastasis within five years, in breast cancer patients with Stage I or Stage II disease. Agendia’s BluePrint test builds on the foundational prognostic precision of MammaPrint, to classify the breast cancer into one of four molecular subtypes. These results help to predict clinical outcomes in women with early-stage breast cancer. Using Agilent’s SureSelect target enrichment system, the new RNA-Seq kit will enable Agendia to develop and perform the MammaPrint and BluePrint tests, as next-generation sequencing assays. This capability will allow the tests to be run in decentralized settings that can utilize a larger footprint of next-generation sequencing instruments, thus affording patients global access to these revolutionary tests. The ability to perform these tests at locations closer to the patients, provides greater accessibility and the potential for more cancer patients to get better individualized treatment management. The initial phase of kit development is expected to be completed in 2017, providing early access to limited markets in Europe. Agilent Technologies is a leading provider of target enrichment for next-generation DNA and RNA sequencing solutions. Target enrichment saves researchers time and resources by enabling them to focus on regions of interest rather than looking at the entire genome. Agendia is a leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products. Agendia’s MammaPrint microarray-based diagnostic test is currently the only FDA-cleared breast cancer recurrence test intended for use in breast cancer patients of all ages. “ We have had a long-term collaboration with Agilent and are excited to further our relationship,” said Mark Straley, chief executive officer of Agendia. “ The addition of Agilent’s RNA next-generation sequencing technologies to our current microarray platform will allow us to penetrate international markets where decentralized kit offerings are preferred, and help us to achieve our core mission of providing all women access to advanced cancer diagnostics.” " We are excited to partner once again with Agendia," said Jacob Thaysen, president of Agilent's Diagnostics and Genomics Group. “ Both companies share a common goal of fighting cancer and this agreement leverages Agendia’s expertise in molecular cancer diagnostics and Agilent’s leading NGS target enrichment technologies to ultimately enable the best treatment decision to be made for each individual.” Agilent Technologies Inc. (NYSE: A), is a global leader in analytical laboratory technologies. With more than 50 years of insight and innovation, our instruments, software, services, solutions and people provide trusted answers to our customers’ most challenging questions. The company generated revenues of $4.20 billion in fiscal 2016 and employs about 13,000 people worldwide. Information about Agilent is available at www.agilent.com. Agendia is a privately held, leading molecular diagnostics company that develops and markets 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. Our offerings include MammaPrint®, a 70-Gene Breast Cancer Risk-of-Recurrence test, and BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology. Information about Agilent is available at www.agendia.com.


Dublin, May 24, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2021- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment" report to their offering. This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by over 360 tables & figures over 397 pages. The personalized medicine (global & USA) market is presented as follows: By Company (e.g., Qiagen, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD) By Segment (Targeted therapeutics, Companion Diagnostics, Liquid Biopsies) By Sub-market (Companion diagnostic, targeted cancer therapeutic, medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy) By Therapy (Cancer, Cardiovascular, Infectious Disease) Key Opinion Leaders that contributed to interview questions within the report include: - Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group - Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James's Hospital and Trinity College Dublin, Ireland - Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Department of Veterans Affairs, Washington DC - Elaine Kenny, PhD, Founder, Elda Biotech, Dublin 2, Ireland - Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine - Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine - David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine - Deborah Phippard, PhD, Vice President, Research, Precision for Medicine - Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine A wealth of financial data & business strategy information is provided including: - Company financials, sales & revenue figures - Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies - Business Model Strategies for Providers. Provider Systems and Academic Medical Centres - Business Model Strategies for Payers & Governments - Private and Public Funding and Personalized Medicine Reimbursement - Revisions to Current Payment Systems and intellectual property - How to Gain Market Penetration in the EU - Cost-effectiveness and Business Value of Personalized Medicine - Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations) - Comprehensive account of company product portfolios & kits SWOT, Economic & Regulatory Environment specifics include: - Key strengths, weaknesses and threats influencing leading player position within the market - Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing) - Top fastest growing market segments and emerging opportunities - Top pharmaceutical companies within the IPM by market share and revenue - Comprehensive product portfolios, R&D activity and pipeline therapeutics - M&A activity and future strategies of top personalized medicine pharmacos - Personalized Medicine Regulation (USA, UK, Germany, France, Spain, Italy) - CE-marked Personalized Medicine/Diagnostic Tests - FDA Advances in Personalized Medicine Regulation This report highlights a number of significant pharmacos and gives details of their operations, products, financials and business strategy. What you will gain: - An in-depth understanding of the global personalized medicine market and it's environment - Current market facts, figures and product lines of key players in the industry - Emerging trends in key markets such as the US, UK, Germany and France - Knowledge of how the personalized medicine market will integrate into the global healthcare market - Technical insights into new generation sequencing technologies and ultra-high throughput sequencing - Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies - FDA approved pharmacogenetic tests and recognized biomarkers - Information on key government and regulatory policies - Strategies on how to adapt and restructure current business models to this industry This report tackles key concerns to the personalized medicine market such as: - Lack of regulatory policy and legislation in the US and Europe - Reimbursement schemes and payers concerns - Transition of investigational diagnostic assays and therapeutics to clinical practice - Direct to consumer (DTC) test kits and implications for the public Who should read this report? - Pharmaceutical, biotechnology and diagnostic companies (CEOs, VPs, Business Development, C-Suite)with an interest in personalized medicine - Industry professionals and business strategists will discover key information to propel their policies - Investors will gain inside information to dominant players in the industry and future forecasts - Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment This report will tell you if the companies mentioned are: - Strong, competitive players - Pooling their resources for specific growth and therapeutic areas - Investing strategically in R&D - Have a history of strategic M&A activity Key Topics Covered: 1.0 Executive Summary 2.0 Introduction and Background 3.0 Personalized Medicine Targeted Therapeutics and Associated Companion Diagnostics 4.0 Personalized Medicine and Integration into the Healthcare System 5.0 Private and Public Funding and Personalized Medicine Reimbursement 6.0 European Personalized Medicine Market - Payments and Investment 7.0 Personalized Medicine -Business Model Analysis 8.0 Personalized Medicine Main Industry Players 14.0 Interviews with Key Opinion Leaders Companies Mentioned - 23andMe - Abbott Laboratories - Abbott Molecular Inc. - Admera Health (GENEWIZ) - Affymetrix - Agendia - Alere - Amgen - Astex Pharmaceuticals - AstraZeneca - Atossa Genetics - Becton Dickenson - bioMerieux - BristolMyersSquibb - Cancer Genetics - Celera (Quest Diagnostics) - Celldex Therapeutics - Claritas Genomics - CuraGen - Danaher (Leica Biosystems) - deCode Genetics (Amgen) - EDP Biotech - ELDA BioTech - Eisai - Eli Lilly - Foundation Medicine - Genelex - GlaxoSmithKline - HalioDx - Human Longevity Inc (Cypher Genomics) - Ikonisys - Illumina - InterGenetics - Johnson & Johnson - LabCorp - Life Technologies - MDxHealth - Merck - MolecularMD Corporation - Monogram Biosciences - Myriad - NanoString Technologies - Nodality - Novartis MDx - Orion Genomics - Oxford BioTherapeutics - Pfizer - Qiagen - Roche Molecular Diagnostics - Sanofi - SensiGen - Siemens Healthcare Diagnostics - Takeda - Thermo Fisher Scientific - Transgenomic - Ventana (Roche) - Vermillion (Ciphergen) - Vertex Pharmaceuticals For more information about this report visit http://www.researchandmarkets.com/research/zbw7h4/personalized


Dublin, May 24, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2021- Strategic Analysis of Industry Trends, Technologies, Participants, and Environment" report to their offering. This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by over 360 tables & figures over 397 pages. The personalized medicine (global & USA) market is presented as follows: By Company (e.g., Qiagen, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD) By Segment (Targeted therapeutics, Companion Diagnostics, Liquid Biopsies) By Sub-market (Companion diagnostic, targeted cancer therapeutic, medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy) By Therapy (Cancer, Cardiovascular, Infectious Disease) Key Opinion Leaders that contributed to interview questions within the report include: - Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group - Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James's Hospital and Trinity College Dublin, Ireland - Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Department of Veterans Affairs, Washington DC - Elaine Kenny, PhD, Founder, Elda Biotech, Dublin 2, Ireland - Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine - Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine - David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine - Deborah Phippard, PhD, Vice President, Research, Precision for Medicine - Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine A wealth of financial data & business strategy information is provided including: - Company financials, sales & revenue figures - Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies - Business Model Strategies for Providers. Provider Systems and Academic Medical Centres - Business Model Strategies for Payers & Governments - Private and Public Funding and Personalized Medicine Reimbursement - Revisions to Current Payment Systems and intellectual property - How to Gain Market Penetration in the EU - Cost-effectiveness and Business Value of Personalized Medicine - Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations) - Comprehensive account of company product portfolios & kits SWOT, Economic & Regulatory Environment specifics include: - Key strengths, weaknesses and threats influencing leading player position within the market - Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing) - Top fastest growing market segments and emerging opportunities - Top pharmaceutical companies within the IPM by market share and revenue - Comprehensive product portfolios, R&D activity and pipeline therapeutics - M&A activity and future strategies of top personalized medicine pharmacos - Personalized Medicine Regulation (USA, UK, Germany, France, Spain, Italy) - CE-marked Personalized Medicine/Diagnostic Tests - FDA Advances in Personalized Medicine Regulation This report highlights a number of significant pharmacos and gives details of their operations, products, financials and business strategy. What you will gain: - An in-depth understanding of the global personalized medicine market and it's environment - Current market facts, figures and product lines of key players in the industry - Emerging trends in key markets such as the US, UK, Germany and France - Knowledge of how the personalized medicine market will integrate into the global healthcare market - Technical insights into new generation sequencing technologies and ultra-high throughput sequencing - Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies - FDA approved pharmacogenetic tests and recognized biomarkers - Information on key government and regulatory policies - Strategies on how to adapt and restructure current business models to this industry This report tackles key concerns to the personalized medicine market such as: - Lack of regulatory policy and legislation in the US and Europe - Reimbursement schemes and payers concerns - Transition of investigational diagnostic assays and therapeutics to clinical practice - Direct to consumer (DTC) test kits and implications for the public Who should read this report? - Pharmaceutical, biotechnology and diagnostic companies (CEOs, VPs, Business Development, C-Suite)with an interest in personalized medicine - Industry professionals and business strategists will discover key information to propel their policies - Investors will gain inside information to dominant players in the industry and future forecasts - Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment This report will tell you if the companies mentioned are: - Strong, competitive players - Pooling their resources for specific growth and therapeutic areas - Investing strategically in R&D - Have a history of strategic M&A activity Key Topics Covered: 1.0 Executive Summary 2.0 Introduction and Background 3.0 Personalized Medicine Targeted Therapeutics and Associated Companion Diagnostics 4.0 Personalized Medicine and Integration into the Healthcare System 5.0 Private and Public Funding and Personalized Medicine Reimbursement 6.0 European Personalized Medicine Market - Payments and Investment 7.0 Personalized Medicine -Business Model Analysis 8.0 Personalized Medicine Main Industry Players 14.0 Interviews with Key Opinion Leaders Companies Mentioned - 23andMe - Abbott Laboratories - Abbott Molecular Inc. - Admera Health (GENEWIZ) - Affymetrix - Agendia - Alere - Amgen - Astex Pharmaceuticals - AstraZeneca - Atossa Genetics - Becton Dickenson - bioMerieux - BristolMyersSquibb - Cancer Genetics - Celera (Quest Diagnostics) - Celldex Therapeutics - Claritas Genomics - CuraGen - Danaher (Leica Biosystems) - deCode Genetics (Amgen) - EDP Biotech - ELDA BioTech - Eisai - Eli Lilly - Foundation Medicine - Genelex - GlaxoSmithKline - HalioDx - Human Longevity Inc (Cypher Genomics) - Ikonisys - Illumina - InterGenetics - Johnson & Johnson - LabCorp - Life Technologies - MDxHealth - Merck - MolecularMD Corporation - Monogram Biosciences - Myriad - NanoString Technologies - Nodality - Novartis MDx - Orion Genomics - Oxford BioTherapeutics - Pfizer - Qiagen - Roche Molecular Diagnostics - Sanofi - SensiGen - Siemens Healthcare Diagnostics - Takeda - Thermo Fisher Scientific - Transgenomic - Ventana (Roche) - Vermillion (Ciphergen) - Vertex Pharmaceuticals For more information about this report visit http://www.researchandmarkets.com/research/zbw7h4/personalized

Loading Agendia Inc. collaborators
Loading Agendia Inc. collaborators