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HLH and MAS are potentially life threatening disorders resulting in an overactive immune response that can damage healthy tissue and organs. HLH can be inherited (primary or familial HLH), or acquired (secondary HLH). MAS is secondary to multiple auto immune disorders and  prompt diagnosis of Primary HLH and inherited immune disorders is essential and can result in successful treatment of the disease. Claritas' HLH Region of Interest was developed with rheumatologists, immunologists and oncologists including Lauren Henderson, MD, MMSc, Director of the HLH/MAS workgroup at Boston Children's Hospital, and is unique because the assay includes genes associated with both familial HLH and auto-inflammatory conditions that can cause MAS. HLH/MAS joins the Claritas menu of Immunology, Neurology, and Hematology Regions of Interest, and is based on Claritas' innovative dual-capture, dual sequencing platform method  unique to the industry. This "Orthogonal Approach" simultaneously confirms ~95% of all exome variants with Sanger confirmation for the remaining 5%, providing high confidence clinical results. As with all Claritas Region of Interest tests, ordering clinicians can access full exome data provided via WuXiNextCODE Health's software.* The WuXiNextCODE CSA is the world's most widely-used system for sequence-based rare disease diagnosis. CSA provides access via an always-on, harmonized knowledgebase of all major global databases and reference sets; the ability to conduct queries according to a range of modes of inheritance without specialized informatics expertise; and instant visualization of mutations in raw sequence data. More information regarding the HLH/MAS Region of Interest can be found at www.claritasgenomics.com/test/hlh-region-interest-trio-or-proband-only. For ordering information, email info@claritasgenomics.com, visit our website at claritasgenomics.com or call Client Services at (617)553-5880 / (855)373-9003 (toll free). *not available in New York Claritas Genomics was created by leading pediatric medical centers Boston Children's Hospital and Cincinnati Children's Hospital in partnership with Cerner Corp, WuXiNextCODE Genomics, and ThermoFisher Scientific to serve children affected with complex genetic disorders by providing timely and accurate results, and resolving families' long search for answers.  By combining clinical expertise of the world's best pediatric specialists with innovative best in class information and genomic platform solutions, Claritas' mission is to improve patient care and enable new discoveries for pediatric precision medicine. Now is the time to integrate genomics into clinical practice to inform, guide and improve medical treatment for kids around the world. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/claritas-genomics-launches-hemophagocytic-lymphohistiocytosismacrophage-activation-system-hlhmas-region-of-interest-300458806.html


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


"New York State approval for our entire menu is a key component of our quality and regulatory strategy," says David Margulies, MD and Claritas Executive Chair. "Today's approval, Claritas' combination of NYS, ISO 15189, and CLIA Certification demonstrates our commitment to Total Quality Management Practice to ensure the best possible results for patients and families." All the tests employ Claritas' innovative dual-capture, dual sequencing whole exome platform method that is unique to the industry. This "Orthogonal Approach", provides the highest confidence in clinical results, while the whole exome platform allows to add additional testing without additional sequencing costs. Clinical interpretation is facilitated by WuxiNextCODE's  software. The WuXi NextCODE CSA is the world's most widely-used system for sequence-based rare disease diagnosis. It provides access through every interface to an always-on, fully-harmonized knowledgebase of all major global databases and reference sets; the ability to conduct queries according to a range of modes of inheritance without specialized informatics expertise; and instant visualization of mutations in raw sequence data. More information regarding the Claritas' test menu can be found at www.claritasgenomics.com. For ordering information, email info@claritasgenomics.com, visit our website at claritasgenomics.com or call Client Services at (617)553-5880/(855)373-9003(toll free). Claritas Genomics was created by leading pediatric medical centers Boston Children's Hospital and Cincinnati Children's Hospital in partnership with Cerner Corp, WuxiNextCode Genomics, and ThermoFisher Scientific to serve children affected with complex genetic disorders by providing timely and accurate results, resolving families' long search for answers.  By combining clinical expertise of the world's best pediatric specialists with innovative best in class information and genomic platform solutions, Claritas' mission is to improve patient care and enable new discoveries for pediatric precision medicine. Now is the time to integrate genomics into clinical practice to inform, guide and improve medical treatment for kids around the world. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/claritas-genomics-receives-new-york-state-nys-approval-for-bone-marrow-failure-hlhmas-nephrotic-syndrome-and-mitochondrial-dna-tests-300473290.html


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

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