Liquid vs Tissue Biopsy Concordance in Samples of 1st Suspected BCa Recurrence/Metastasis and Evaluation of DefineMBC Comprehensive Cancer Profiling Liquid Biopsy LDT

The purpose of this study is to continue to develop a liquid biopsy (minimally invasive blood test) that can be used to confirm if breast cancer has spread throughout the body and if this liquid biopsy test can provide comparable information to a highly invasive tissue biopsy. The knowledge gained in this study could be used in future studies to confirm cancer recurrence using a safe and minimally invasive procedure. The research will consist of looking for tumor cell(s) circulating in the blood stream and if they are present to characterize them so that more information about the disease can be collected. This information may help us to better understand how to fight cancer.

开始日期2020-09-28

申办/合作机构

Protean Biodiagnostics, Inc.

[+6]

NCT04241237

/ Unknown statusN/AIIT

Concordance Between Liquid and Tissue Biopsy in Newly Diagnosed Metastatic Breast Cancer

Tissue biopsy is a procedure to remove a piece of tissue (sample of cells) from the body to be analyzed in a laboratory, and it is commonly performed to confirm diagnosis of a patient with symptoms of breast cancer recurrence. It may also provide information on tumor markers (hormone receptors, HER2) that can guide treatment decisions. The goal of this study is to determine whether blood tests (which require less-invasive procedures) can be used to confirm diagnosis of suspected recurrent breast cancer (as compared to tissue biopsy).
Investigators plan to investigate blood factors which include circulating tumor cells (CTCs - i.e., cancer cells that can be detected in the blood), circulating tumor DNA (ctDNA - i.e., pieces of DNA from cancer cells that can be found in the blood), as well as other biomarkers. Investigators will conduct this study in 120 participants who present with suspected breast cancer recurrence and symptoms of cancer that has spread to other areas in the body.
Participants will be asked for blood collection within 30 days before tissue biopsy. The tissue will be analysed locally to determine the presence of cancer and the tumor markers listed above. The blood will be processed and stored for analysis of CTCs and ctDNA. If these blood tests show concordance with tissue based tests (presence of cancer cells, hormone receptors & HER2 status), these tests could be used in future studies to confirm diagnosis using a non-invasive procedure. Also, investigators believe that the results of this study can influence other research of early-stage recurrent breast cancer.

开始日期2020-07-01

申办/合作机构

Lawson Health Research Institute

[+5]

NCT04067713

/ Active, not recruitingN/AIIT

Plasma Analysis for Response Assessment and to DIrect the manaGement of Metastatic Prostate Cancer

This research study is looking into plasma tumour deoxyribonucleic acid (ptDNA), a substance that is shed by cancer cells and can be detected in blood samples. Analysing ptDNA may therefore be able to provide more information about the characteristics of prostate cancer.
This study will involve taking additional blood samples during standard treatment. The samples will be analysed in laboratories for levels of Prostate Specific Antigen (PSA); which gives information on the activity of the cancer; ptDNA; circulating tumour cells (ones that are derived from the cancer) (CTCs) and cells that affect immune system.
The PARADIGM study is not, therefore, testing a new drug. Instead, the study is investigating if a new blood test can provide information about which current treatments for prostate cancer will work best for future patients with this disease.
In the future and PARADIGM's ultimate aim is to identify which of the current treatment options will work best for patients. The research may also identify new opportunities for the development of drugs potentially useful in treating prostate cancer.

开始日期2019-09-20

申办/合作机构

University College London

[+1]

100 项与 Epic Sciences, Inc. 相关的临床结果

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项与 Epic Sciences, Inc. 相关的文献（医药）

2025-12-31·Journal of Enzyme Inhibition and Medicinal Chemistry

Tetra-anionic porphyrin mimics protein-protein interactions between regulatory particles and the catalytic core, allosterically activating human 20S proteasome

Article

作者: Coletta, M. ; Purrello, R. ; Milardi, D. ; Fattorusso, C. ; Tundo, G. R. ; Sbardella, D. ; Gaczynska, M. ; Tkachuk, O. ; D’Urso, A. ; Santoro, A. M. ; Cunsolo, A. ; Osmulski, P. A. ; Persico, M.

Decreased proteasome activity is a hallmark of brain and retinal neurodegenerative diseases (Alzheimer's, Parkinson's diseases, glaucoma) boosting the search for molecules acting as proteasome activators. Based on the hypothesis of an electrostatic key code driving catalytic core particle (20S) activation by regulatory particles (RPs), we identified the tetra-anionic meso-Tetrakis(4-sulphonatophenyl)-porphyrin (H2TPPS) as a new activator of human proteasome. By means of an integrated approach, including bioinformatics, enzymatic kinetic analysis, atomic force microscopy, and dynamic docking simulations, we show how binding of H2TPPS affects the closed/open conformational equilibrium of human 20S to ultimately promote substrate gate opening and proteolytic activity. These outcomes support our hypothesis and pave the way to the rational discovery of new proteasome allosteric modulators able to reproduce the key structural elements of regulatory particles responsible for catalytic activation.

2025-02-01·European Urology Oncology

Liquid Biopsy in Progressing Prostate Cancer Patients Starting Docetaxel with or Without Enzalutamide: A Biomarker Study of the PRESIDE Phase 3b Trial

Article

作者: Senkus, Elżbieta ; Brighi, Nicole ; Thakali, Suparna ; Feyerabend, Susan ; Orlando, Francesco ; Matveev, Vsevolod B ; Merseburger, Axel S ; Attard, Gerhardt ; Boysen, Gunther ; Esen, Adil ; Jayaram, Anuradha ; Åström, Lennart ; López-Brea Piqueras, Marta ; Demichelis, Francesca ; Bracarda, Sergio ; Wetterskog, Daniel ; Wenstrup, Rick ; Cremaschi, Paolo ; Chowdhury, Simon ; Martins, Karla ; Iwata, Kenneth ; Gourgioti, Georgia ; Serikoff, Alexis ; Gupta, Santosh ; Gonzalez-Billalabeitia, Enrique ; Vainauskas, Osvaldas ; Wingate, Anna ; Ruiz-Vico, Maria ; Castellano-Gauna, Daniel

BACKGROUND AND OBJECTIVEThe PRESIDE (NCT02288247) randomized trial demonstrated prolonged progression-free survival (PFS) with continuing enzalutamide beyond progression in metastatic castration-resistant prostate cancer (mCRPC) patients starting docetaxel. This study aims to test the associations of PFS and circulating tumor DNA (ctDNA) prior to and after one cycle (cycle 2 day 1 [C2D1]) of docetaxel and with a liquid biopsy resistance biomarker (LBRB; plasma androgen receptor [AR] gain and/or circulating tumor cells [CTCs] expressing AR splice variant 7 [CTC-AR-V7]) prior to continuation of enzalutamide/placebo.METHODSPatients consenting to the biomarker substudy and donating blood before starting docetaxel with enzalutamide/placebo (N = 157) were included. Sequential plasma DNA samples were characterized with a prostate-cancer bespoke next-generation-sequencing capture panel (PCF_SELECT), and CTCs were assessed for AR-V7 (Epic Sciences, San Diego, CA, USA). Cox models, Kaplan-Meier, and restricted mean survival time (RMST) at 18 mo were calculated.KEY FINDINGS AND LIMITATIONSThere was a significant association of worse PFS with pre-docetaxel ctDNA detection (N = 86 (55%), 8.1 vs 10.8 mo hazard ratio [HR] = 1.78, p = 0.004) or persistence/rise of ctDNA at C2D1 (N = 35/134, 5.5 vs 10.9 mo, HR = 1.95, 95% confidence interval [CI] = 1.15-3.30, p = 0.019). LBRB-positive patients (N = 62) had no benefit from continuing enzalutamide with docetaxel (HR = 0.78, 95% CI = 0.41-1.48, p = 0.44; RMST: 7.9 vs 7.1 mo, p = 0.50). Conversely, resistance biomarker-negative patients (N = 87) had significantly prolonged PFS (HR = 0.49, 95% CI = 0.29-0.82, p = 0.006; RMST: 11.5 vs 8.9 mo, p = 0.005). Eight patients were unevaluable. An exploratory analysis identified increased copy-number gains (CDK6/CDK4) at progression on docetaxel. Limitations included relatively low detection of CTC-AR-V7. Validation of impact on overall survival is required.CONCLUSIONS AND CLINICAL IMPLICATIONSLiquid biopsy gives an early indication of docetaxel futility, could guide patient selection for continuing enzalutamide, and identifies cell cycle gene alterations as a potential cause of docetaxel resistance in mCRPC.PATIENT SUMMARYIn the PRESIDE biomarker study, we found that detecting circulating tumor DNA in plasma after starting treatment with docetaxel (chemotherapy) for metastatic prostate cancer resistant to androgen deprivation therapy can predict early how long patients will take to respond to treatment. Patients negative for a liquid biopsy resistance biomarker (based on the status of androgen receptor (AR) gene and AR splice variant 7 in circulating tumor cells) benefit from continuing enzalutamide in combination with docetaxel, while patients positive for the resistance biomarker did not. Additionally, we identified alterations in the cell cycle genes CDK6 and CDK4 as a potential genetic cause of resistance to docetaxel, which may support testing of specific drugs targeting these alterations.

2024-05-02·Cancer Research

Abstract PO5-04-05: Clinical validation of the concordance performance of ERBB2 status by single-cells genomics ERBB2 (HER2) amplification Assay in Circulating Tumor Cells (CTCs) from patients with matched HER2 status from metastatic tissue biopsies

作者: Lam, Ernest ; Schwartzberg, Lee ; Slade, Megan ; Huang, Shuguang ; Wenstrup, Rick ; Caro, Giuseppe Di

AbstractBackgroundLiquid biopsies are a non-invasive diagnostic approach for detecting CTCs that may provide clinically actionable information for treatment decisions for metastatic breast cancer (MBC) patients when a conventional biopsy is infeasible. Blood-based liquid biopsy has the potential advantage that it allows broad sampling of metastatic tumor clones because it is capable of and likely to obtain cellular and genomic contributions from more than one metastatic site. Here we report the concordance performance of HER2 positivity by single-cell CTC genomics ERBB2 (HER2) amplification in patients with matched HER2 status from metastatic tissue biopsies.MethodsA prospective Clinical Experience Program for CTC ERBB2 (HER2) Assay across 25 different United States-based cancer centers, was used to recruit 128 MBC patients with documented standard-of-care metastatic tissue biopsies performed within the last 5 years (Days from tissue biopsy to liquid biopsy, Median: 19.5; interquartile range: 40.75) CTCs from blood collection at each respective clinical site were isolated from plasma, nucleated cells were plated, & slides were bio-banked for Immunofluorescent staining & subsequent imaging in a CAP CLIA lab. CTCs were identified using Epic Sciences digital imaging & machine learning algorithms. Individual CTCs were sequenced for genomic quantification of chromosomal instability (LSTs) and ERBB2 (HER2) amplification.ResultsWithin the clinical validation cohort of 128 MBC patients, 30% (38/128) were HER2-positive by standard pathologic criteria (IHC 3+ or IHC2+/ISH+) in metastatic tissue biopsies. Among the 64 out of 128 cases with reportable results by the CTC ERBB2 (HER2) amplification on chromosomally unstable CTCs, 31% (20/64) of patients had ERBB2 amplification. Concordance between CTC single cell genomics and available tissue results for HER2 positivity showed a sensitivity of 69% and specificity of 78%. We then addressed the effects of two known biological confounders to the use of tissue biopsy for HER2 status determination: 1) tissue biopsies performed on bone metastases, 2) tumor evolution driven by treatment pressure over time leading to potential HER2 conversion and tumor heterogeneity. Thus, we performed subgroup analysis including only validation set patients with tissue biopsies performed on non-bone tissues, which showed slightly improved concordance to the tissue comparator with a Sensitivity of 86%, and Specificity of 75%. Next, to exclude the possibility of tumor evolution we selected only patients with the HER2 status comparator performed on non-bone tissue biopsies contemporaneous (Days from tissue biopsy to liquid biopsy, Median: 14; interquartile range: 22) to the blood draw for the CTC ERBB2 (HER2) amplification assay. This showed dramatically improved concordance performance with a Sensitivity of 100%, and a Specificity of 75%.ConclusionsBlood and tissue are two biologically distinct sample types where variations in HER2 and other biomarker results might be expected due to analytic, temporal and clinical differences. These data indicate that determination of HER2 status by single cell genomic ERBB2 (HER2) amplification assay can aid in the clinical assessment of ERBB2 status in patients with metastatic breast cancer (MBC) for whom tissue biopsy for HER2 status is not available, or infeasible. Additionally, these results provide evidence of the contribution of site differences (bone) of metastatic biopsies and also tumor evolution to discordance between the CTC ERBB2 (HER2) Assay and tumor biopsy.Citation Format: Giuseppe Di Caro, Ernest Lam, Megan Slade, Shuguang Huang, Rick Wenstrup, Lee Schwartzberg. Clinical validation of the concordance performance of ERBB2 status by single-cells genomics ERBB2 (HER2) amplification Assay in Circulating Tumor Cells (CTCs) from patients with matched HER2 status from metastatic tissue biopsies [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-04-05.

项与 Epic Sciences, Inc. 相关的新闻（医药）

2024-03-28

·PRNewswire

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

并购IPO

2024-03-19

·Business Wire

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.

诊断试剂

2024-03-01

·Business Wire

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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