e15063 Background: Analysis of transcriptome-wide gene expression has the potential to provide insights into biological pathways and molecular mechanisms that regulate disease progression and treatment response. RNA-Seq is considered the gold standard for transcriptome analysis; however, it may not perform well with older, archival formalin-fixed paraffin embedded (FFPE) tissues or low-quality/low-quantity RNA. To help researchers overcome these challenges, HTG Molecular Diagnostics developed a Research Use Only, extraction-free, targeted human transcriptome panel with an automated, proprietary web-based data analysis pipeline that provides fast, accurate, and repeatable quantitative gene expression data for 19,398 protein-coding mRNA targets from lysed FFPE tissue samples or extracted RNA (eRNA). Methods: Panel precision was evaluated by Lin’s Concordance Correlation Coefficient (Lc) using FFPE tissue lysates and eRNA from FFPE and fresh frozen tissues, including FFPE blocks that were older than ten years. The accuracy of the HTP to perform differential expression analysis was assessed by comparing it to RNA-Seq using FFPE samples from different cancer indications. The agreement of the log fold changes between the two platforms was measured by Pearson Correlation Coefficient (Pc). Additionally, a cohort of 83 breast cancer FFPE samples, that had also been evaluated for estrogen (ER) and progesterone (PR) receptor expression by immunohistochemistry (IHC), were used to determine the correlation between HTP gene expression and orthogonal IHC data. Results: The precision of the panel measured by Lc, ranged from 0.90-0.94 across multiple operators, instruments, lots, and processing days, demonstrating that the HTP is a precise and robust panel. In addition, HTP is a competitive alternate to RNA-seq (estimated log-fold changes, Pc = 0.83 between the platforms). Archival samples demonstrated high repeatability (Pc > 0.9) with sample pass rates of 100% for HTP, which further confirms panel’s robust performance. Furthermore, the HTP gene expression results correlated with the IHC markers for ER (Pc = 0.92) and PR (Pc = 0.88) receptor status in a cohort of 83 breast cancer samples, which highlights the potential of the panel to replace IHC staining while providing expression data on thousands of additional genes. Conclusions: The results demonstrate the HTP is a powerful tool for comprehensive gene expression analysis that addresses several key limitations of RNA-Seq. The HTP is precise, accurate, user-friendly (avoids extraction-bias, fewer steps, automated data analysis), and efficient (quicker, requires lower amounts of sample, works well with samples of low quality and archival samples). Collectively, the data demonstrate HTP has the potential to be used for biomarker discovery and the development of clinical solutions.

01 Jul 2021·Journal of Immunological MethodsQ4 · MEDICINE

Cross-platform comparison of immune-related gene expression to assess intratumor immune responses following cancer immunotherapy

Q4 · MEDICINE

Article

Author: Fong, Lawrence ; Yang, Hai ; Cooley, James ; He, Tao ; Cheung, Alexander ; Cham, Jason ; Kerns, B J ; Thompson, Debrah ; Hagihara, Katsunobu ; Zhang, Li ; Fan, Frances

Neoadjuvant immunotherapy can induce immune responses within the tumor microenvironment. Gene expression can be used to assess responses with limited amounts of conventionally-fixed patient-derived samples. We aim to assess the cross-platform concordance of immune-related gene expression data. We performed comparisons across three panels in two platforms: Nanostring nCounter® PanCancer Immune Profiling Panel (nS), HTG EdgeSeq Oncology Biomarker Panel (HTG OBP) and Precision Immuno-Oncology Panel (HTG PIP). All tissue samples of 14 neoadjuvant GM-CSF treated, 14 neoadjuvant Provenge treated, and 12 untreated prostate cancer patients were radical prostatectomy (RP) tissues, while 6 prostatitis patients and 6 non-prostatitis subjects were biopsies. For all 52 patients, more than 90% of the common genes were significantly correlated (p < 0.05) and more than 76% of the common genes were highly correlated (r > 0.5) between any two panels. Co-inertia analysis also demonstrated high overall dataset structure similarity (correlation>0.84). Although both dimensionality reduction visualization analysis and unsupervised hierarchical cluster analysis for highly correlated common genes (r > 0.9) suggested a high-level of consistency across the panels, there were subsets of genes that were differentially expressed across the panels. In addition, while the effect size of the differential testing for neoadjuvant treated vs. untreated localized prostate cancer patients across the panels were significantly correlated, some genes were only differentially expressed in the HTG panels. Finally, the HTG PIP panel had the best classification performance among the 3 panels. These differences detected may be a result of the different panels or platforms due to their technical setting and focus. Thus, researchers should be aware of those potential differences when deciding which platform and panel to use.

01 Sep 2019·The Journal of Molecular DiagnosticsQ3 · MEDICINE

Reliable Gene Expression Profiling from Small and Hematoxylin and Eosin–Stained Clinical Formalin-Fixed, Paraffin-Embedded Specimens Using the HTG EdgeSeq Platform

Q3 · MEDICINE

Article

Author: Stern, Mark ; Vitazka, Patrik ; Wang, Lisu ; Qi, Zhenhao ; Kerkar, Sid P ; Lawson, Byron ; Desai, Keyur ; Cogswell, John

Clinical biomarker studies are often hindered by the scarcity or suboptimal quality of biological specimens. EdgeSeq, a transcriptomics analysis platform, combines quantitative nuclease protection assay technology with next-generation sequencing, using small amounts of starting material and delivering reproducible gene expression profiles from challenging material, such as formalin-fixed, paraffin-embedded (FFPE) tissue. To evaluate EdgeSeq for analysis of archives of stained FFPE tissue, EdgeSeq was performed on unstained, hematoxylin and eosin (H&E)-stained, and immunohistochemistry-stained slides from patients with small-cell and non-small-cell lung cancer. Pairwise comparisons of gene expression profiles from stained and unstained slides showed higher Pearson correlation coefficients with H&E staining (0.86 to 0.97) than with immunohistochemistry staining (0.21 to 0.56). A 25-gene interferon-γ signature score from unstained slides showed a Pearson correlation coefficient of 0.92 with H&E-stained slides and a significant Spearman correlation (P = 0.0025) with immune scores. To test gene expression profiling in small samples, FFPE sample equivalents were examined from 5.0 to 0.08 mm² of a section (5 μm thick); sample equivalents ≥0.31 mm² showed alignment rates >69% and pairwise Pearson correlation coefficients ≥0.87. EdgeSeq can, thus, be used to profile small and H&E-stained FFPE tumor specimens to obtain biomarker data from limited tissue in oncology clinical trials and enable research into tumor microenvironment and immune cell engagement with tumors at the locoregional level.

News (Medical) associated with HTG Molecular Diagnostics, Inc.

28 Mar 2024

·www.prnewswire.com

World Molecular Diagnostics for Cancer Markets, 2023-2024 and 2027 with Profiles of Over 120 Companies

DUBLIN, March 28, 2024 /PRNewswire/ -- The "Molecular Diagnostics for Cancer: Markets Forecasts by Cancer Type, Product, and Place with Executive & Consultant Guides and Customization. 2023 to 2027" report has been added to ResearchAndMarkets.com's offering. Exciting technical developments especially in companion diagnostics, hold the promise of a dynamic, growing and evolving world market where single laboratories serve a global patient base. The report provides data that analysts and planners can use. Hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help understand test pricing in detail. Make facilities planning decisions. Forecast demand for new testing regimes or technologies. Make research investment decisions. Assistance in providing specific growth and market size estimates for new technology tests is normally provided without additional charges. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities' growth. Again, assistance in using the information is normally provided without additional charges. After a pandemic interruption the market for Cancer Molecular Diagnostics is back on the growth path. And growth is accelerating in every segment. We include a special segment Cancer Companion Diagnostics, a new segment of the market that is reshaping the industry. Over 120 companies are profiled. A range of dynamic trends are pushing market growth and company valuations. Key Market Trends Personalized medicine Pharmacogenomics Liquid biopsy Minimal residual disease testing Emergence of new economies with large markets Physician diagnostics being displaced by new intelligent diagnostic tests Key Topics Covered: 1 Market Guides 1.1 Cancer MDx - Strategic Situation Analysis 1.2 Guide for Executives, Marketing, and Business Development Staff 1.3 Guide for Management Consultants and Investment Advisors 2 Introduction and Market Definition 2.1 What are Molecular Diagnostics? 2.2 The Diagnostics Revolution 2.3 Market Definition 2.3.1 Revenue Market Size 2.4 Methodology 2.4.1 Methodology 2.4.2 Sources 2.4.3 Authors 2.5 Perspective: Healthcare and the IVD Industry 2.5.1 Global Healthcare Spending 2.5.2 Spending on Diagnostics 2.5.3 Important Role of Insurance for Diagnostics 3 Market Overview 3.1 Market Segments 3.1.1 Traditional Market Segmentation 3.1.2 Laboratory Focus and Segmentation 3.2 Industry Structure 3.2.1 Hospital Testing Share 3.2.2 Economies of Scale 3.2.3 Physician Office Labs 3.2.4 Physicians and POCT 4 Market Trends 4.1 Factors Driving Growth 4.1.1 New Diagnostics Create New Markets 4.1.2 New Roles for Diagnostics 4.1.3 The Aging Effect 4.1.4 Expanding the Pharmaceutical Toolbox 4.1.5 Regulatory Retreat 4.2 Factors Limiting Growth 4.2.1 Falling Prices 4.2.2 Lower Costs 4.2.3 Wellness has a Downside 4.3 Instrumentation, Automation and Diagnostic Trends 4.3.1 Traditional Automation and Centralization 4.3.2 The New Automation, Decentralization and Point Of Care 4.3.3 Instruments Key to Market Share 4.3.4 Bioinformatics Plays a Role 4.3.5 PCR Takes Command 4.3.6 Next Generation Sequencing Fuels a Revolution 4.3.7 NGS Impact on Pricing 4.3.8 Whole Genome Sequencing, A Brave New World 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment 4.3.10 Shifting Role of Diagnostics 4.3.11 Multiplexing and Foundation One 4.3.12 Pharmacogenomics Technology 4.3.13 Gene Editing and Gene Therapy 5 Molecular Diagnostics Recent Developments 5.1 Recent Developments - Importance and How to Use This Section 5.1.1 Importance of These Developments 5.1.2 How to Use This Section 5.2 Grail Cancer Test Faces New Clinical Questions 5.3 Freenome Acquires Cancer Dx Firm Oncimmune 5.4 Quest Diagnostics to Acquire Liquid Biopsy Firm Haystack Oncology 5.5 Ultima Genomics, Genome Insight Partner on WGS for Cancer Patients 5.6 Digital Pathology Meets Cancer Sequencing 5.7 Exact Sciences Preps Expanded Oncology Portfolio 5.8 Qiagen Details Oncology Plans for Digital PCR Platform 5.9 Sema4 Exiting Reproductive Health Screening 5.10 Thermo Fisher Introduces Cancer Profiling Assay 5.11 Genomic Test IDs Cysts Likely to Progress to Cancer 5.12 Naveris to Commercialize Virus-Related Cancer Tests 5.13 Larger Liquid Biopsy Panels Loom 5.14 Halo Diagnostics to Offer Genomic Profiling Tests 5.15 BillionToOne Raises $125M 5.16 Local Cancer Genomic Profiling Options Grow 5.17 German MDx Firm Mainz Biomed Raises $10M in IPO 5.18 Guardant Health Q3 Revenues Up 27 Percent 5.19 BforCure Raises $2.3M to Adapt Rapid PCR Platform for Cancer Detection 5.20 Nucleix to Invest in Early-Stage Lung Cancer Dx 5.21 Labcorp, GeneCentric Partnering on Development of RNA-Based Cancer Diagnostics 5.22 Grail Gets Approval for Galleri Multicancer Test 5.23 Finnish Firms to Form Point-of-Care Testing Firm 5.24 Datar Cancer Genetics Expands to Dx and Screening 5.25 HTG Molecular Diagnostics: HTG Transcriptome Panel 5.26 PacBio's Omniome Acquisition Shortens Path to Clinical 5.27 Invitae to Acquire Genosity for $200M 5.28 Bio-Techne Obtains CE Mark for Exosomal Liquid Biopsy Prostate Test 5.29 Agilent Technologies to Acquire Liquid Biopsy Firm Resolution Bioscience 5.30 Natera Revenues Grow 35 Percent 5.31 AnchorDx Closes $40M Financing Round 5.32 Exact Sciences Strategy for End-to-End Cancer Testing 5.33 Genomics England: Whole Genome Sequencing for Cancer Patients to Launch 6 Profiles of Key MDx Companies 6.1 10x Genomics, Inc. 6.2 Abbott Laboratories 6.3 AccuraGen Inc. 6.4 Adaptive Biotechnologies 6.5 Aethlon Medical 6.6 Agilent/Dako 6.7 Anchor Dx 6.8 ANGLE plc 6.9 ARUP Laboratories 6.10 AVIVA Systems Biology 6.11 Baylor Miraca Genetics Laboratories 6.12 Beckman Coulter Diagnostics 6.13 Becton, Dickinson and Company 6.14 BGI Genomics Co. Ltd 6.15 BillionToOne 6.16 Bioarray Genetics 6.17 Biocartis 6.18 Biocept, Inc. 6.19 Biodesix Inc. 6.20 BioFluidica 6.21 BioGenex 6.22 BioIVT 6.23 Biolidics Ltd 6.24 bioMerieux Diagnostics 6.25 Bioneer Corporation 6.26 Bio-Rad Laboratories, Inc 6.27 Bio-Reference Laboratories 6.28 Bio-Techne 6.29 Bioview 6.30 Bolidics 6.31 Boreal Genomics 6.32 Bristol-Myers Squibb 6.33 Burning Rock 6.34 Cardiff Oncology 6.35 Caris Molecular Diagnostics 6.36 Castle Biosciences, Inc. 6.37 Celemics 6.38 CellCarta 6.39 CellMax Life 6.40 Cepheid (Danaher) 6.41 Charles River Laboratories 6.42 Circulogene 6.43 Cizzle Biotech 6.44 Clinical Genomics 6.45 Cytolumina Technologies Corp. 6.46 Datar Cancer Genetics Limited 6.47 Diagnologix LLC 6.48 Diasorin S.p.A. 6.49 Dxcover 6.50 Enzo Biochem 6.51 Epic Sciences 6.52 Epigenomics AG 6.53 Eurofins Scientific 6.54 Exact Sciences 6.55 Fabric Genomics 6.56 Fluxion Biosciences 6.57 Freenome 6.58 FUJIFILM Wako Diagnostics 6.59 Fulgent Genetics 6.60 Fyr Diagnostics 6.61 GeneFirst Ltd. 6.62 Genetron Holdings 6.63 GenomOncology 6.64 GILUPI Nanomedizin 6.65 Guardant Health 6.66 HansaBiomed 6.67 HeiScreen 6.68 Helomics 6.69 HTG Molecular Diagnostics 6.70 iCellate 6.71 ICON PLC 6.72 Illumina 6.73 Incell Dx 6.74 Inivata 6.75 INOVIQ 6.76 Integrated Diagnostics 6.77 Invitae Corporation 6.78 Invivogen 6.79 Invivoscribe 6.80 Janssen Diagnostics 6.81 Lunglife AI Inc 6.82 MDNA Life SCIENCES, Inc. 6.83 MDx Health 6.84 Menarini Silicon Biosystems 6.85 Mesa Laboratories, Inc. 6.86 Millipore Sigma 6.87 Miltenyi Biotec 6.88 miR Scientific 6.89 Myriad Genetics/Myriad RBM 6.90 NantHealth, Inc. 6.91 Natera 6.92 NeoGenomics 6.93 NGeneBio 6.94 Novogene Bioinformatics Technology Co., Ltd. 6.95 Oncocyte 6.96 OncoDNA 6.97 Ortho Clinical Diagnostics 6.98 Oxford Nanopore Technologies 6.99 PamGene 6.100 Panagene 6.101 Perkin Elmer 6.102 Personal Genome Diagnostics 6.103 Personalis 6.104 Precipio 6.105 Precision Medicine Group 6.106 PrecisionMed 6.107 Predicine 6.108 Promega 6.109 Qiagen 6.110 Rarecells SAS 6.111 RareCyte 6.112 Roche Molecular Diagnostics 6.113 Screencell 6.114 Sema4 Holdings 6.115 Sense Biodetection 6.116 Siemens Healthineers 6.117 simfo GmbH 6.118 Singlera Genomics Inc. 6.119 Singulomics 6.120 SkylineDx 6.121 Standard BioTools 6.122 Sysmex Inostics 6.123 Tempus Labs, Inc. 6.124 Thermo Fisher Scientific Inc. 6.125 Todos Medical 6.126 Variantyx 6.127 Veracyte 6.128 Volition 6.129 Vortex Biosciences 6.130 Vyant Bio 6.131 Zhejiang Orient Gene Biotech For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo - SOURCE Research and Markets

AcquisitionIPO

19 Mar 2024

·www.businesswire.com

Global Companion Diagnostic Markets 2024: Bioinformatics Plays a Role, PCR Takes Command, Companion Diagnostics Blurs Diagnosis and Treatment - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Companion Diagnostic Markets - The Future of Diagnostics by Application, Technology and Funding with Customized Forecasting/Analysis, and Executive and Consultant Guides" report has been added to ResearchAndMarkets.com's offering. Will Personalized Companion Diagnostics become the norm for diagnostics? Companion Diagnostics are poised to revolutionize the diagnostics industry. The market is moving out of the lab and into the clinic. Oncology, especially immune-oncology is leading the way. And the FDA is holding the door open for this diagnostic technology of the future. Find out the latest outlook for this important market. Learn all about how diagnostic players are jockeying for position with their pharmaceutical counterparts and creating new and significant business opportunities. And some players are already taking the lead. It is a dynamic market situation with enormous opportunity. Diagnostic companies are trying to back the right horse. Science is racing forward. And the cost of molecular diagnostics continues to fall. "Companion Diagnostic Markets, the Future of Diagnostics" provides data that analysts and planners can use. Hundreds of pages of information including a complete list of United States Medicare Fee Payment Schedules to help understand the New Nucleic Acid Test Pricing in detail. Forecast demand for new testing regimes or technologies. Make research investment decisions. Specific growth and market size estimates for your area of interest is normally provided without additional charges. Existing laboratories and hospitals can use the information directly to forecast and plan for clinical facilities growth. Again, assistance in using the information is normally provided without additional charges. The report includes detailed breakouts for 18 Countries and 4 Regions. A detailed breakout for any country or specific area in the world is available to purchasers of the report. Key Topics Covered: 1 Market Guides 1.1 Strategic Situation Analysis 1.2 Guide for Executives, Marketing, Sales and Business Development Staff 1.3 Guide for Management Consultants and Investment Advisors 2 Introduction and Market Definition 2.1 What are Companion Diagnostics? 2.2 The Personalized Medicine Revolution 2.3 Market Definition 2.3.1 Revenue Market Size 2.4 Methodology 2.4.1 Methodology 2.4.2 Sources 2.4.3 Authors 2.5 Perspective: Healthcare and the IVD Industry 2.5.1 Global Healthcare Spending 2.5.2 Spending on Diagnostics 2.5.3 Important Role of Insurance for Diagnostics 3 Market Overview 3.1 Players in a Dynamic Market 3.1.1 Academic Research Lab 3.1.2 Diagnostic Test Developer 3.1.3 Instrumentation Supplier 3.1.4 Chemical/Reagent Supplier 3.1.5 Pathology Supplier 3.1.6 Independent Clinical Laboratory 3.1.7 Public National/regional Laboratory 3.1.8 Hospital Laboratory 3.1.9 Physicians Office Lab (POLS) 3.1.10 Audit Body 3.1.11 Certification Body 3.2 Personalized Medicine and Companion Diagnostics 3.2.1 Basics 3.2.2 Method 3.2.3 Disease risk assessment 3.2.4 Applications 3.2.5 Diagnosis and intervention 3.2.5.1 Companion Diagnostics 3.2.6 Drug development and usage 3.2.7 Respiratory proteomics 3.2.8 Cancer genomics 3.2.9 Population screening 3.2.10 Challenges 3.2.11 Regulatory oversight 3.2.12 Intellectual property rights 3.2.13 Reimbursement policies 3.2.14 Patient privacy and confidentiality 3.3 Chromosomes, Genes and Epigenetics 3.3.1 Chromosomes 3.3.2 Genes 3.3.3 Epigenetics 3.4 Cancer Genes 3.4.1 Germline vs Somatic 3.4.2 Changing Clinical Role 3.5 Structure of Industry Plays a Part 3.5.1 New Pharmaceutical Funding Market 3.5.2 Economies of Scale 3.5.2.1 Hospital vs. Central Lab 3.5.3 Physician Office Labs 3.5.4 Physicians and POCT 4 Market Trends 4.1 Factors Driving Growth 4.1.1 Level of Care 4.1.2 Immuno-oncology 4.1.3 Liability 4.1.4 The Aging World 4.2 Factors Limiting Growth 4.2.1 State of knowledge 4.2.2 Genetic Blizzard 4.2.3 Protocol Resistance 4.2.4 Regulation and coverage 4.3 Instrumentation, Automation and Diagnostic Trends 4.3.1 Traditional Automation and Centralization 4.3.2 The New Automation, Decentralization and Point Of Care 4.3.3 Instruments Key to Market Share 4.3.4 Bioinformatics Plays a Role 4.3.5 PCR Takes Command 4.3.6 Next Generation Sequencing Fuels a Revolution 4.3.7 NGS Impact on Pricing 4.3.8 Whole Genome Sequencing, A Brave New World 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment 4.3.10 Shifting Role of Diagnostics 5 Companion Diagnostics Recent Developments 5.1 Recent Developments - Importance and How to Use This Section 5.1.1 Importance of These Developments 5.1.2 How to Use This Section 5.2 JaxBio to Create Array-Based Cancer Tests 5.3 Agilent, Qiagen Win FDA Approvals Companion Diagnostics 5.4 Navignostics Using Single-Cell Spatial Proteomics 5.5 HMNC Brain Health to Develop Companion Diagnostics 5.6 Propath UK, Nucleai Partner on Spatial Proteomics 5.7 Becton Dickinson, Labcorp Collaborate for Flow Cytometry-Based Companion Diagnostics 5.8 Almac, AstraZeneca Strike CDx Development Pact 5.9 Avalon GloboCare, Lu Daopei Hematology Institute to Develop Cell Therapy CDx 5.10 Burning Rock Secures Lung Cancer NGS Test Approval in China 5.11 TenSixteen Bio Developing Drugs, Companion NGS Tests 5.12 Guardant Health Plans New Comprehensive Assay 5.13 Thermo Fisher, Oncocyte Ink Comarketing Deal for Cancer IVDs 5.14 Qiagen, Denovo Biopharma to Develop Liquid Biopsy CDx Test 5.15 Japanese Approves Thermo Fisher Scientific Oncomine Assay as CDx 5.16 Promega, Henlius to Develop Microsatellite Instability CDx for Cancer Drug 5.17 Natera Aims to Lead Market in Solid Tumor Adjuvant CDx 5.18 Oncocyte Details Expansions Plans 5.19 Agilent Acquires Resolution Biosciences 5.20 Qiagen, Inovio Expand CDx Partnership 5.21 AmoyDx, AstraZeneca Strike Ovarian Cancer CDx Alliance 5.22 NeoGenomics to Grow Through CDx Agreements, Acquisitions 5.23 Personalis Neoantigen Platform Driving Improved Immunotherapy Prediction 5.24 Biocartis Collaborating with Endpoint Health on CDx Tests for Idylla Platform 5.25 FDA Approves Foundation Medicine Test as CDx for Three Targeted Therapies 5.26 Promega to Develop MSI Assay as CDx 5.27 Guardant Health to Develop CDx for Janssen 5.28 Burning Rock Bio, CStone Pharmaceuticals to Codevelop CDx 5.29 FDA Approval for FoundationOneCDx 5.30 FDA finalizes CDx Guidance 5.31 QIAGEN Launches CDx Therascreen BRAF Test 6 Profiles of Key Players (Partial List) 10x Genomics, Inc Abbott Laboratories AccuraGen Inc Adaptive Biotechnologies Aethlon Medical Agilent/Dako Biocept, Inc Biodesix Inc BioFluidica BioGenex BioIVT Biolidics Ltd bioMerieux Diagnostics Bioneer Corporation Bio-Rad Laboratories, Inc CellMax Life Cepheid (Danaher) Charles River Laboratories Circulogene Dxcover Element Biosciences Enzo Biochem Epic Sciences Epigenomics AG Eurofins Scientific GILUPI Nanomedizin Guardant Health HansaBiomed HeiScreen Helomics HTG Molecular Diagnostics Invivoscribe Janssen Diagnostics Lunglife AI Inc MDNA Life SCIENCES, Inc MDx Health Menarini Silicon Biosystems Mesa Laboratories, Inc Natera NeoGenomics NGeneBio Novogene Bioinformatics Technology Co., Ltd Oncocyte OncoDNA Ortho Clinical Diagnostics Oxford Nanopore Technologies PamGene Panagene Perkin Elmer Qiagen Rarecells SAS RareCyte Roche Molecular Diagnostics Screencell Sema4 Holdings Sense Biodetection Siemens Healthineers simfo GmbH Stilla Technologies Sysmex Inostics Tempus Labs, Inc Thermo Fisher Scientific Inc Todos Medical Ultima Genomics Veracyte Volition Vortex Biosciences Vyant Bio For more information about this report visit https://www.researchandmarkets.com/r/61suqi About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Diagnostic Reagents

01 Mar 2024

·www.businesswire.com

World Human Gene Sequencing Markets, Strategies, Trends, and Forecasts Report 2023-2024 and 2027 with Executive and Consultant Guides - 2023 to 2027 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Human Gene Sequencing Markets, Strategies & Trends - Forecasts by Application, by Technology, by Workflow, by Product, and by Country, with Executive and Consultant Guides - 2023 to 2027" report has been added to ResearchAndMarkets.com's offering. Will all newborns receive genetic testing at birth? What segments are growing fastest? Where are the opportunities now that sequencing has gone mainstream? The plummeting costs for Genome Sequencing is creating a gold rush. New consumers, new technologies, new market niches. It is reminiscent of the birth of the internet industry; a wide range of well funded players are racing for market share on a global stage. This report forecasts the market size out for five years. The report includes detailed breakouts for 14 countries and 5 regions. Tumor Cell Sequencing? Direct to Consumer? Gene Expression? Find out about the technology in readily understood terms that explain the jargon. What are the issues? Find the opportunities, and the pitfalls. Understand growth expectations and the ultimate market forecasts for the next five years. Scope of the Report The Global Market for Human Genome Sequencing Global Market Overview by Country Global Market by Application - Overview Global Market by Technology - Overview Global Market by Workflow - Overview Global Market by Product - Overview Market Sizes by Application Hereditary Gene Sequencing Market NIPT Gene Sequencing Market Oncology Market Psychology Market WGES Gene Sequencing Market Pharmacogenomics Market DTC Gene Sequencing Market Research Gene Sequencing Market Other Application Market Market Sizes by Technology Sanger Sequencing Market NGS/2G Market 3G/Long Market Other Technology Market Market Sizes by Workflow Sequencing Market Sample Prep Market Analysis Market Market Sizes by Product Instruments Market Consumables Market Software & Services Market Vision of the Future of Human Gene Sequencing Key Topics Covered: 1 Market Guides 1.1 Human Gene Sequencing Markets - Strategic Situation Analysis & COVID Impact 1.2 Guide for Executives, Marketing, Sales and Business Development Staff 1.3 Guide for Management Consultants and Investment Advisors 2 Introduction and Market Definition 2.1 Gene Sequencing Definition In This Report 2.1.1 Gene Sequencing 2.1.2 Hereditary 2.1.3 Non Invasive Prenatal Testing 2.1.4 Oncology 2.1.5 Psychology 2.1.6 WGES 2.1.7 Pharmacogenomic 2.1.8 Direct to Consumer 2.1.9 Research 2.1.10 Other 2.2 The Genomics Revolution 2.3 Market Definition 2.3.1 Revenue Market Size 2.4 Methodology 2.5 Perspective: Healthcare and the IVD Industry 2.5.1 Global Healthcare Spending 2.5.2 Spending on Diagnostics 2.5.3 Important Role of Insurance for Diagnostics 2.6 Chromosomes, Genes and Epigenetics 2.6.1 Chromosomes 2.6.2 Genes 2.6.3 Epigenetics 2.6.4 Genetic Testing vs. Gene Sequencing 2.6.5 Cost and Pricing Practice 3 Global Listing of Sequencer Installed Base - Location & Contacts 3.1 Notes to Installed Base Listing 3.2 Illumina Installed Base 4 Market Overview 4.1 Players in a Dynamic Market 4.1.1 Academic Research Lab 4.1.2 Diagnostic Test Developer 4.1.3 Instrumentation Supplier 4.1.4 Chemical/Reagent Supplier 4.1.5 Pathology Supplier 4.1.6 Independent Clinical Laboratory 4.1.7 Public National/regional Laboratory 4.1.8 Hospital Laboratory 4.1.9 Physicians Office Lab (POLS) 4.1.10 Audit Body 4.1.11 Certification Body 4.2 Human Gene Sequencing -Markets, Examples and Discussion 4.2.1 Inherited Disease - Not what it used to be 4.2.1.1 Clinical and Research Lines Blur 4.2.1.2 Genetic Counselling - Not so simple anymore 4.2.1.3 The Genetic Blizzard - Issues of Access and Payment 4.2.2 Newborn Screening - The Standard of Care 4.2.2.1 Newborn Screening - Do Parents Want to Know? 4.2.3 NIPT - We've Only Just Begun 4.2.3.1 NIPT, IVF and the Fertility Practice - PGS, PGD, CCS 4.2.3.2 NIPT in the Future - Beyond Inherited Disease 4.2.4 Oncology - Understanding Two Worlds 4.2.4.1 The Tumor - A Sequence of Sequencing 4.2.4.2 The Tumor - Biopsy and Liquid Biopsy 4.2.4.3 The Human Genome - Predisposition and Prognosis 4.2.5 Pharmacogenomics 4.2.5.1 Sequencing Not the Only Player 4.2.5.2 New Roles for Old Drugs - A Research Bonanza? 4.2.6 Direct To Consumer - More Than Meets the Eye 4.2.6.1 DTC - How Many Segments? 4.3 Industry Structure 4.3.1 Hospital's Testing Share 4.3.2 The Rise of the Sequencing Lab 4.3.3 Sequencing as a Commodity 4.3.4 Informatics 4.3.5 Instrument Manufacturer Role 4.3.6 Healthcare Industry Impacts - Still Struggling 4.3.7 Can the Healthcare Industry Adapt? 4.3.8 Genetic Counselling as an Industry 4.3.9 Sequencing Adoption and Cannibalization 5 Market Trends 5.1 Factors Driving Growth 5.1.1 New Diagnoses 5.1.2 Wellness and Prevention 5.1.3 Fertility Technology 5.1.4 Cancer - Screening, Management and Monitoring 5.2 Factors Limiting Growth 5.2.1 Increased Competition Lowers Price 5.2.2 Lower Costs 5.2.3 Healthcare Cost Concerns Curtail Growth 5.2.4 Wellness has a downside 5.3 Sequencing Instrumentation 5.3.1 Instrumentation Tenacity 5.3.2 Declining Cost of Instruments Changes Industry Structure 5.3.3 Long Reads - Further Segmentation 5.3.4 Linked Reads 5.3.5 New Sequencing Technologies 6 Human Gene Sequencing Recent Developments 6.1 Recent Developments - Importance and How to Use This Section 6.1.1 Importance of These Developments 6.1.2 How to Use This Section 6.2 Natera Files Suit Against NeoGenomics 6.3 Genomics England to Sequence 100K Newborns 6.4 Novigenix Raises $14M for NGS based Liquid Biopsy 6.5 LetsGetChecked Launching New PGx Service 6.6 Qiagen, Neuron23 Partner for NGS Diagnostic 6.7 Harbinger Health Technology Focused On Oncogenesis 6.8 Delfi Diagnostics to Develop Early Detection Test 6.9 Dante Labs to Introduce WGS to Italian Healthcare System 6.10 Invitae Neurodevelopmental Disorders Testing Service 6.11 Thermo Fisher Obtains CE Mark for Ion Torrent Genexus 6.12 Myriad Genetics Launches Suite of Cancer Tests 6.13 Oncocyte and Thermo Fisher Strike Partnership Deal 6.14 Illumina Partners With Precision Medicine to Assess Liquid Biopsy 6.15 Sysmex Inostics Develops Ultra-Sensitive Liquid Biopsy 6.16 Twist Bioscience, Centogene Partner on NGS-Based Rare Disease Testing 6.17 Strata Oncology Trial Supports NGS Assay 6.18 NYU Gets FDA Clearance for Sequencing Test 6.19 NeoGenomics to Acquire Inivata 6.20 OncoDNA, Institut Curie Partner on Liquid Biopsy Research 6.21 Cancer Heritability Gene Set Expanded 6.22 Whole-Genome Sequencing Could Replace Cytogenetics 6.23 Twist Bioscience, Berry Genomics Partner on Targeted NGS Assays 6.24 Ancestry Shutters Health Offering 6.25 Genetron Health Targeting Early Cancer Detection 6.26 Pan-European Initiative to Build Tools for Sharing Genomic Data 6.27 UK Government Unveils New Genomic Healthcare Strategy 6.28 Foundation Medicine Liquid Biopsy Gets FDA Approval 6.29 American Heart Association Develops Genetic Testing Guidelines 6.30 Yourgene Health Gets CE Mark for Iona NIPT Test 6.31 NorthShore Looks to Expand Genomics Integration Into Primary Care 6.32 Germline Results From Tumor Sequencing Guides Precision Therapy 6.33 FDA Clears Cancer Genomic Profiling From Personal Genome Diagnostics 6.34 BillionToOne Closes $15M Series A Follow-on Round 6.35 Clinics to Integrate Genomics Into Primary Care Appendices United States Medicare System: January 2022 laboratory Fees Schedule The Whole Genome Sequence of SARS-CoV-2 Profiles of Key Companies 10x Genomics, Inc. 23andME Inc. Abbott Laboratories AccuraGen Inc. Adaptive Biotechnologies Admera Health, LLC Agilent/Dako Akonni Biosystems Amoy Diagnostics Co., Ltd. Ancestry.com LLC Anchor Dx Arc Bio Arrayit Corporation ARUP Laboratories Astrid Bio Baylor Miraca Genetics Laboratories Beckman Coulter Diagnostics Becton, Dickinson and Company BGI Genomics Co. Ltd Bioarray Genetics Biocept, Inc. Biodesix Inc. BioFluidica BioGenex Biolidics Ltd bioMerieux Diagnostics Bioneer Corporation Bio-Rad Laboratories, Inc. Bio-Techne C2i Genomics Caris Molecular Diagnostics CellMax Life Centogene Cepheid (Danaher) Circulogene Clinical Genomics Color Genomics Complete Genomics, Inc. - A BGI Company Dante Labs Datar Cancer Genetics Limited Diasorin S.p.A. Element Biosciences Epic Sciences Epigenomics AG Eurofins Scientific Excellerate Bioscience Fabric Genomics Freenome FUJIFILM Wako Diagnostics Fujirebio Fulgent Genetics GE Global Research Gene by Gene, Ltd. Genedrive GeneFirst Ltd. Genetron Holdings Genewiz Genomics England Genomics Personalized Health (GPH) GenomOncology Genzyme Corporation Grifols Guardant Health Guardiome HeiScreen Helix Helomics Hologic HTG Molecular Diagnostics Human Longevity, Inc. iCellate Illumina Incell Dx Inivata Integrated Diagnostics Invitae Corporation Invivoscribe Karius Letsgetchecked Lexagene Lunglife AI Inc Macrogen MDNA Life SCIENCES, Inc. MDx Health Medgenome Meridian Bioscience Mesa Biotech (Thermo Fisher) Mesa Laboratories, Inc. miR Scientific MNG Labs NantHealth, Inc. Natera Nebula Genomics 448 NeoGenomics New England Biolabs, Inc. NGeneBio Novogene Bioinformatics Technology Co., Ltd. Omega Bioservices Oncocyte OncoDNA OpGen ORIG3N, Inc. Origene Technologies Oxford Nanopore Technologies Panagene Perkin Elmer Personal Genome Diagnostics Personalis Precipio PrecisionMed Promega Protagen Diagnostics Qiagen QuantuMDx Regeneron Pharmaceuticals Roche Molecular Diagnostics Roswell Biotechnologies Seegene SeLux Diagnostics Sema4 Holdings Sequencing.com Siemens Healthineers simfo GmbH Singlera Genomics Inc. Singular Genomics SkylineDx Standard BioTools Sure Genomics, Inc. Sysmex Sysmex Inostics Tempus Labs, Inc. Thermo Fisher Scientific Inc. Ultima Genomics Variantyx Volition Vyant Bio For more information about this report visit https://www.researchandmarkets.com/r/nqo2do About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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