BioFluidica Inc.

Chapel Hill, NC, United States

BioFluidica Inc.

Chapel Hill, NC, United States
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Dublin, Aug. 15, 2017 (GLOBE NEWSWIRE) -- The "Non-Invasive Cancer Diagnostics Market (2nd Edition), 2017-2030" report has been added to Research and Markets' offering. The Non-Invasive Cancer Diagnostics Market (2nd Edition), 2017-2030' report provides an extensive study on liquid biopsy kits/assays that are either commercialized or are under development for diagnosis and/or monitoring of different types of cancer. The market is characterized by the presence of several companies that have proprietary technologies/platforms for either isolation/enrichment/enumeration of CTCs or for molecular characterization/sequencing of the genetic material extracted from the CTCs/exosomes. Based on these platforms, a number of liquid biopsy kits and systems are being developed for non-invasive diagnosis, prognosis, and patient and recurrence monitoring of different cancer indications. Such kits are likely to transform the cancer diagnostics market with many commercial success stories in the near future. The market is primarily led by start-ups/small companies, such as (in alphabetical order) CellMax Life, Celsee Diagnostics, Datar Genetics, DiaDx, EONE-DIAGNOSTICS Genome Center, Exosome Sciences, iCellate Medical, Inivata, IVDiagnostics, LCM Genect and MDNA Life Sciences. It also has presence of mid to large-sized pharma players; notable examples include (in alphabetical order) Biocartis, Counsyl, Foundation Medicine, Genomic Health and NeoGenomics Laboratories. In addition to the aforementioned players, a number of pharma giants are also developing assets in this field. Prominent players under this category include (in alphabetical order) Affymetrix, Menarini Silicon Biosystems, Myriad Genetics, QIAGEN, Roche, Siemens Healthineers and Thermo Fisher Scientific. As companies continue to initiate and expand their research programs and platforms in this area, one of the key objectives of this report was to understand the future potential of the market. In addition, we have provided a comprehensive market estimation to determine the global evolution of the liquid biopsy market. This has been done by evaluating the likely success of key applications of early diagnosis, recurrence monitoring and patient monitoring. We have included insights on the likely regional evolution of the market covering US, EU5 and rest of the world. In addition, we have estimated the likely contribution of different target patient populations to the global market; this covered key indications including (in alphabetical order) bladder cancer, breast cancer, colorectal cancer, gastric cancer, lung cancer, melanoma, ovarian cancer, pancreatic cancer and prostate cancer. Further, we segmented the market by the type of markers (CTCs, ctNAs, exosomes) and the sample source (blood, urine, saliva) used in different liquid biopsies. In order to account for uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios for the time period 2017-2030. The conservative, base and optimistic scenarios represent three different tracks of the industry's evolution. The research, analysis and insights presented in this report are backed by the deep understanding of key insights gathered from both secondary and primary research. 1. PREFACE 2. EXECUTIVE SUMMARY 3. INTRODUCTION 3.1. Chapter Overview 3.2. Cancer Statistics and Burden of the Disease 3.3. Importance of Early Detection in Cancer 3.4. Detecting Cancer: Screening vs. Diagnosis 3.5. Conventional Invasive Cancer Diagnostic Tests 3.5.1. Biopsy 3.5.1.1. Fine Needle Aspiration Biopsy 3.5.1.2. Core Needle Biopsy 3.5.1.3. Vacuum-Assisted Biopsy 3.5.1.4. Image-Guided Biopsy 3.5.1.5. Sentinel Node Biopsy 3.5.1.6. Surgical Biopsy 3.5.1.7. Endoscopic Biopsy 3.5.1.8. Bone Marrow Biopsy 3.5.2. Endoscopy 3.6. Need for Non-Invasive Approaches 3.7. Costs and Benefits Associated with Non-Invasive Tests 4. CONCEPT OF NON-INVASIVE CANCER SCREENING AND DIAGNOSTICS 4.1. Chapter Overview 4.2. Diagnostic Imaging 4.2.1. Magnetic Resonance Imaging (MRI) 4.2.2. Mammography 4.2.3. Bone Scan 4.2.4. Computerized Tomography (CT) Scan 4.2.5. Integrated PET-CT Scan 4.2.6. Ultrasound 4.2.7. Barium Enema 4.3. Screening Assays 4.3.1. Papanicolaou Test (Pap Test) and Human Papilloma Virus Test (HPV Test) 4.3.2. Tumor Marker Test 4.3.3. Fecal Occult Blood Tests (FOBT) 4.3.4. Digital Rectal Exam (DRE) 4.3.5. Multigated Acquisition (MUGA) Scan 4.4. Advanced Non-Invasive Approaches 4.4.1. Liquid Biopsy 4.4.2. Cytogenetic/Gene Expression Studies 4.4.3. Molecular Signature Based Non-Invasive Methods 4.4.4. Saliva-Based Oral Cancer Diagnostics 4.4.5. Vital Staining 4.4.6. Optical Biopsy 4.4.7. Other Techniques 5. MARKET LANDSCAPE 5.1. Chapter Overview 5.2. Liquid Biopsy: Development Landscape 5.2.1. Liquid Biopsy Tests: Distribution by Development Stage 5.2.2. Liquid Biopsy Tests: Distribution by Sample Type 5.2.3. Liquid Biopsy Tests: Distribution by Type of Markers Detected 5.2.4. Liquid Biopsy Tests: Distribution by Indication 5.2.5. Liquid Biopsy Tests: Distribution by Type of Application 5.2.6. Liquid Biopsy Tests: Distribution by Geographical Coverage 5.2.7. Liquid Biopsy Tests: Distribution by Leading Players 5.3. Liquid Biopsy: Technologies, Platforms, Systems and Instruments 6. LIQUID BIOPSY MARKET: KEY INSIGHTS 6.1. Chapter Overview 6.2. Liquid Biopsy Tests: Competitive Landscape of Developers 6.3. Liquid Biopsy Tests: Distribution by Application and Target Indications 6.4. Emerging Trends on Non-Invasive Cancer Diagnostics on Social Media 6.4.1. Non-Invasive Cancer Diagnostics: Historical Trends by Twitter Volume (2010-2016) 6.4.2. Non-Invasive Cancer Diagnostics: Twitter Word Cloud (2010, 2012, 2014, 2016) 6.4.3. Non-Invasive Cancer Diagnostics: Twitter Trends for Popular Indications (2010-2016) 6.4.4. Non-Invasive Cancer Diagnostics: Twitter Trends for Samples Types (2010-2016) 7. LIQUID BIOPSY: DETAILED OUTLOOK 7.1. Chapter Overview 7.2. Non-Invasive Methods Over Biopsies for Detection of Cancer 7.3. Circulating Biomarkers for Cancer 7.3.1. Circulating Tumor Cells (CTCs) 7.3.1.1. Advantages Associated with the Use of CTCs 7.3.1.2. Challenges Associated with the Use of CTCs 7.3.2. Circulating Tumor DNA (ctDNA) 7.3.3. Exosomes 7.4. Liquid Biopsy Based Tests and Systems 7.4.1. BioFluidica CTC Isolation Technology, CTC Analysis System and Test, BioFluidica/Roche 7.4.2. CancerIntercept Detect and CancerIntercept Monitor, Pathway Genomics 7.4.3. Cancertrack, Datar Genetics 7.4.4. CellMax-LBx Liquid Biopsy and CellMax-CRC Colorectal Cancer Blood Test, CellMax Life 7.4.5. CELLSEARCH System and CELLSEARCH CTC Test, Menarini Silicon Biosystems 7.4.6. cobas EGFR Mutation Test v2, Roche 7.4.7. LiquidBiopsy Rare Cell Isolation Platform, ClearID Total Insight Breast Cancer, ClearID Lung Cancer and Clear ID Melanoma, Cynvenio Biosystems 7.4.8. Oncocount, Oncotrace, Oncotrial and Metastat, R.G.C.C. Group 7.4.9. OncoBEAM CRC RAS Kit, Sysmex Inostics/Merck 7.4.10. OnTarget Assay, Boreal Genomics 7.4.11. PrediSeq-Prostate and PrediSeq-Lung, Predicine 7.4.12. SelectMDx, MDxHealth 7.4.13. ViewRNA CTC Platform and Assay, Affymetrix 7.4.14. Velox, IVDiagnostics 7.4.15. ApoStream System and Technology, ApoCell 7.4.16. IsoPic, iCellate Medical 7.4.17. Parsortix System, ANGLE 7.5. Companion Liquid Biopsies: Recent Developments 7.5.1. Biocept and Baylor College of Medicine 7.5.2. Tokai Pharmaceuticals and QIAGEN 7.5.3. ANGLE and MD Anderson Cancer Center 7.5.4. AstraZeneca and QIAGEN 7.5.5. Sysmex Inostics and Bayer Healthcare 8. VENTURE CAPITAL FUNDING 8.1. Chapter Overview 8.2. Types of Funding 8.3. Liquid Biopsy Market: Funding Instances, 2011-2017 8.4. Liquid Biopsy Market: Distribution by Year 8.5. Liquid Biopsy Market: Distribution of Type of Model 8.6. Leading Players: Distribution by Funding Instances 9. COMPANY VALUATION ANALYSIS 9.1. Chapter Overview 9.2. Company Valuation: Methodology 9.3. Company Valuation: Categorization by Multiple Parameters 9.3.1. Categorization by Google Hits Score 9.3.2. Categorization by Awards Score 9.3.3. Categorization by Twitter Score 9.3.4. Categorization by Twitter Followers Score 9.3.5. Categorization by Number of Products 9.3.6. Categorization by Uniqueness Score 9.3.7. Categorization by Weighted Average Score 10. LIQUID BIOPSY: KEY PLAYERS 10.1. Chapter Overview 10.2. Biocartis 10.2.1. Company Overview 10.2.2. Financial Performance 10.2.3. Product Portfolio 10.2.3.1. Idylla ctBRAF Mutation Assay (RUO) 10.2.3.2. Idylla ctKRAS Mutation Assay 10.2.3.3. Idylla ctNRAS-BRAF-EGFR S492R Mutation Assay (RUO) 10.3. Biocept 10.3.1. Company Overview 10.3.2. Financial Performance 10.3.3. Product Portfolio 10.3.3.1. Target Selector Breast Cancer Test 10.3.3.2. Target Selector Lung Cancer Test 10.3.3.3. Target Selector Immuno-Oncology PD-L1 Test 10.3.3.4. Target Selector Gastric Cancer Test 10.3.3.5. Target Selector Colorectal Cancer Test 10.3.3.6. Target Selector Prostate Cancer Test 10.3.3.7. Target Selector Melanoma Test 10.4. Biodesix 10.4.1. Company Overview 10.4.2. Financial Information 10.4.3. Product Portfolio 10.4.3.1. GeneStrat 10.4.3.2. VeriStrat 10.5. Exosome Diagnostics 10.5.1. Company Overview 10.5.2. Financial Information 10.5.3. Product Portfolio 10.5.3.1. ExoDx Prostate (IntelliScore) 10.5.3.2. ExoDx Lung (ALK) 10.5.3.3. ExoDx Lung (EGFR/T790M) 10.5.3.4. ExoDx Solid Tumor 10.6. Genomic Health 10.6.1. Company Overview 10.6.2. Financial Performance 10.6.3. Product Portfolio 10.6.3.1. Oncotype SEQ Liquid Select 10.7. Guardant Health 10.7.1. Company Overview 10.7.2. Financial Information 10.7.3. Product Portfolio 10.7.3.1. Guardant360 10.8. NeoGenomics Laboratories 10.8.1. Company Overview 10.8.2. Financial Performance 10.8.3. Product Portfolio 10.8.3.1. NeoLAB HEME 10.8.3.2. NeoLAB Solid Tumor Monitor (NeoLAB SOLID TUMOR) 10.8.3.3. NeoLAB Prostate 10.8.3.4. NeoLAB EGFR T790M Liquid Biopsy 10.9. Personal Genome Diagnostics (PGDx) 10.9.1. Company Overview 10.9.2. Financial Information 10.9.3. Product Portfolio 10.9.3.1. MetDETECT 10.9.3.2. PlasmaSELECT R 64 10.9.3.3. LungSELECT 10.10. QIAGEN 10.11. Transgenomic 10.12. Trovagene 11. OTHER NON-INVASIVE CANCER DIAGNOSTICS 11.1. Chapter Overview 11.2. Non-Blood Based Biomarker Detection Tests 11.3. DNA Methylation Detection Tests 11.4. Fecal Occult Blood Test (FOBT) AND Fecal Immunochemical Test (FIT) 11.5. MicroRNA (miRNA) Based Test 11.6. Pigmented Lesion Assay 11.7. Stool DNA (sDNA) Testing 11.8. Volatile Organic Compound (VOC) Detection Test 11.9. Other Non-Invasive Cancer Diagnostics: Market Landscape 11.10. Other Non-Invasive Cancer Diagnostics: Survey Analysis 11.10.1. Survey Analysis: Seniority Level of Respondents 11.10.2. Survey Analysis: Type of Product Portfolio 11.10.3. Survey Analysis: Types of Products/Services Offered 11.10.4. Survey Analysis: Type of Application 11.10.5. Survey Analysis: Availability of the Products 11.10.6. Survey Analysis: Likely Market Size 12. MARKET SIZING AND FORECAST 12.1. Chapter Overview 12.2. Forecast Assumptions and Methodology 12.3. Non-Invasive Cancer Diagnostics Market Forecast, 2017-2030 12.3.1. Liquid Biopsy Market Forecast, 2017-2030 12.3.2. Other Non-Invasive Cancer Diagnostics Market Forecast, 2017-2030 13. CONCLUSION 13.1. Timely Disease Detection and Subsequent Monitoring are Critical Elements of Patient Care in the Field of Oncology 13.2. Introduction of Sophisticated Molecular Diagnostics has Facilitated Better Cancer Management 13.3. Liquid Biopsy has Emerged as a Reliable Alternative to the Invasive Methods of Diagnosis 13.4. The Versatile and Patient Friendly Nature of these Diagnostic Tools Cater to a Wide Range of Applications 13.5. The Interest is Gradually Rising with Participation of Several Start-ups Across Different Geographies 13.6. In Addition to Liquid Biopsy, Development of Other Non-Invasive Tests will Further Strengthen the Ongoing Innovation 13.7. Rising Venture Capital Support is Indicative of a Lucrative Future Potential 13.8. Primarily Led by Liquid Biopsy, The Non-Invasive Cancer Diagnostics Market has Emerged as a Multi-Billion Dollar Market 14. INTERVIEW TRANSCRIPTS 14.1. Chapter Overview 14.2. Burkhard Jansen, MD, Chief Medical Officer, DermTech 14.3. Frank Szczepanski, President and CEO, IVDiagnostics 14.4. Riccardo Razzini, Sales and Marketing Manager, LCM Genect 14.5. Nathalie Bernard, Marketing Director, OncoDNA 14.6. Abizar Lakdawalla, Founder, ProXeom 14.7. Mark Li, CEO, Resolution Bioscience 14.8. Christer Ericsson, Chief Scientific Officer, iCellate Medical 14.9. Philippe Nore, CEO and Co-founder, MiNDERA 14.10. Jake Micallef, Chief Scientific Officer, VolitionRx 15. APPENDIX 1: TABULATED DATA 16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS For more information about this report visit https://www.researchandmarkets.com/research/sdm2rg/noninvasive


Dublin, Sept. 15, 2017 (GLOBE NEWSWIRE) -- The "Liquid Biopsy Markets by Lung, Breast, Colorectal, Prostate and Other. 2017-2020 Including Screening Market Potential Size with Executive and Consultant Guides" report has been added to Research and Markets' offering. The Diagnostic, Monitoring and Screening Test opportunities are explored. A revolution in cancer diagnostics is occurring using in vitro blood testing to identify cancer DNA. The technology creates new markets for cancer screening tests. GRAIL, a new company with impressive backing, has announced a single blood test to detect all cancers. The technology is moving faster than the market. New technology that definitively identifies disease conditions from blood samples is poised to replace expensive invasive surgical biopsy procedures. The market is still in its infancy but has outstanding growth potential. The impact on the health care industry is enormous. The report forecasts the market size out to 2020. In addition, the report looks at potential market sizes by country, by cancer and by the three different opportunities: detection, management and screening. Use independent research that makes you the expert. Get our research team working for you by ordering this comprehensive report. Your credit card order sends the report to your inbox instantly. Check all your licensing options but don't worry, your order is available as a credit if you wish to upgrade to more information. Get an extra player on your team as unlimited assistance and breakout data is included with your purchase. Circulating Tumor Cells? Cell Free DNA? Exosomes? Find out about the technology in readily understood terms that explain the jargon. Find the opportunities and the pitfalls. Understand growth expectations and the ultimate potential market size. The report includes detailed breakouts for 15 Countries and 4 Regions along with breakouts for Lung, Breast, Colorectal, Prostate and Other Cancers. What is the size of the huge screening opportunity? They are all listed in Chapter 10. All report data is available in Excel format on request. Make investment decisions and valuations with confidence using the latest data. i. Liquid Biopsy Market - Strategic Situation Analysis ii. Guide for Executives, Marketing, Sales and Business Development Staff iii. Guide for Management Consultants and Investment Advisors 1. Introduction and Market Definition 1.1 What is Liquid Biopsy? 1.2 The Sequencing Revolution 1.3 Market Definition 1.3.1 Volumes 1.3.2 Prices 1.3.3 Revenue Market Size 1.4 Methodology 1.4.1 Authors 1.4.2 Sources 1.5 A Spending Perspective on Liquid Biopsy 1.5.1 An Historical Look at Clinical Testing 2. Market Overview 2.1 Players in a Dynamic Market 2.1.1 Academic Research Lab 2.1.2 Diagnostic Test Developer 2.1.3 Genomic Instrumentation Supplier 2.1.3.1 Cell Separation and Viewing Instrumentation Supplier 2.1.4 Pharmaceutical/Reagent Supplier 2.1.5 Independent Testing Lab 2.1.6 Public National/regional lab 2.1.7 Hospital lab 2.1.8 Physician Lab 2.1.9 Audit Body 2.1.10 Certification Body 2.2 Using Biopsies 2.2.1 Cancer 2.2.2 Precancerous conditions 2.2.3 Inflammatory conditions 2.3 Biopsy Sites 2.4 The Situation Today - Biopsy Analysis 2.5 Evidence of Cancer - Liquid Biopsy Technology 2.5.1 The Big Picture on Liquid Biopsy Technology 2.5.2 The Role of CTCs 2.5.2.1 Types of CTCs 2.5.2.2 CellSearch Detection- Ultimate Sensitivity 2.5.2.3 Epic Sciences Detection- Imaging Takes the Lead 2.5.2.4 Maintrac Detection - The Microscope 2.5.2.5 Other Methods 2.5.3 ctDNA - Going Mainstream? 2.5.4 Exosomes and Micro Vesicles - New Kid on Block 2.6 Cancer Treatment Protocol Under Siege 2.6.1 Issues and Limitations to Liquid Biopsy Adoption - Double Diagnostics 2.6.2 The Cancer Screening Market Opportunity 2.6.2.1 GRAIL - What Is It? 2.6.3 Cancer Management vs. Diagnosis 2.6.3.1 The Role of Risk Assessment 2.6.3.2 Managing Therapy 2.6.3.3 Monitoring Disease - What Is It? 2.6.4 Phases of Adoption - Looking Into The Future 2.6.5 The Promise of Liquid Biopsy 2.7 Structure of Industry Plays a Part 2.7.1 Hospital Testing Share 2.7.2 Economies of Scale 2.7.2.1 Hospital vs. Central Lab 2.7.3 Physician Office Lab's 2.7.4 Physician's and POCT 2.8 Profiles of Key Players 2.8.1 Qiagen 2.8.2 Agena Bioscience 2.8.3 Angle plc 2.8.4 ApoCell 2.8.5 Biocept 2.8.6 BioFluidica 2.8.7 Bio-Rad Laboratories 2.8.8 Boreal Genomics 2.8.10 Chronix Biomedical 2.8.11 Clearbridge BioMedics 2.8.12 Cynvenio 2.8.13 Cytolumina Technologies Corp 2.8.14 CytoTrack 2.8.15 Diagnologix LLC 2.8.16 Epic Sciences 2.8.17 Exosome Diagnostics 2.8.18 Exosome Sciences 2.8.19 Fluidigm Corp 2.8.20 Fluxion Biosciences 2.8.21 Genomic Health 2.8.39 GRAIL 2.8.22 Guardant Health 2.8.23 HansaBiomed 2.8.23 Horizon Discovery 2.8.24 iCellate 2.8.25 Illumina 2.8.26 Inivata 2.8.27 Janssen Diagnostics 2.8.28 Molecular MD 2.8.29 Myriad Genetics 2.8.30 Natera 2.8.31 New Oncology 2.8.32 Personal Genome Diagnostics 2.8.33 RainDance Technologies 2.8.34 Rarecells SAS 2.8.35 Silicon Biosystems 2.8.36 Sysmex Inostics 2.8.37 SRI International 2.8.38 Trovagene 2.8.39 Freenome 3. Market Trends 3.1 Factors Driving Growth 3.1.1 Non Invasive Game Changer 3.1.2 Lower Cost 3.1.3 Greater Accuracy. 3.1.4 Wide Range of Potential Uses 3.1.5 Aging Population 3.2 Factors Limiting Growth 3.2.1 Lower prices 3.2.2 Lack of Standards. 3.2.3 Protocol Resistance. 3.2.4 Initial Adoption Has No Cost Savings 3.3 Instrumentation and Automation 3.3.1 Instruments Key to Market Share 3.3.2 Bioinformatics Plays a Role. 3.4 Diagnostic Technology Development 3.4.1 Next Generation Sequencing Fuels a Revolution 3.4.2 Impact of NGS on pricing 3.4.3 Pharmacogenomics Blurs Diagnosis and Treatment 3.4.4 CGES Testing, A Brave New World 3.4.5 Biochips/Giant magneto resistance based assay 4. Liquid Biopsy Recent Developments 4.1 Recent Developments - Importance and How to Use This Section 4.1.1 Importance of These Developments 4.1.2 How to Use This Section 4.2 Illumina Forms GRAIL to Enable Early Cancer Detection via Liquid Biopsy 4.3 ASCO: Researchers Present Advances, Ongoing Challenges in Liquid Biopsy 4.4 Guardant Health, SWOG Partner on Prospective NSCLC Liquid Biopsy Study 4.5 Qiagen Expands CDx Deal with Tokai; Acquires CTC Assets from AdnaGen 4.6 Biodesix's GeneStrat Liquid Biopsy Lung Cancer Test 4.7 Baylor, TGen Collaborate on Personalized Cancer Treatment Options 4.8 Liquid Biopsy Firm Resolution Bio Gets CLIA Certification for Lab 4.9 Broad Institute Lands $10M Gift to Study Cancer Drug Resistance 4.10 Biocept Q1 Revenues Rise With Test Volume Growth 4.11 CRUK Manchester Institute Joins European Consortium Validating Blood-based Cancer Biomarkers 4.12 New Oncology Closes Financing Round to Promote Genetic Testing from Blood 4.13 Cynvenio to present new clinical data 4.14 EKF, Angle Collaborate for Liquid Biopsy Development 4.15 Trovagene Collaborates with UCSD for EGFR Monitoring in Lung Cancer 4.16 AstraZeneca Initiates CDx Partnerships with Roche, Qiagen 4.17 Horizon, LGC Awarded Research Grant for Cancer Diagnostics 4.18 Merck Serono and Sysmex Inostics Announce Testing Center 4.19 Agena Bioscience Launches Smaller Format MassArray 4.20 Personal Genome Diagnostics Aims for FDA Clearance 4.21 HTG Molecular Diagnostics Files for IPO of up to $60M 4.22 Genomic Health Reports 5 Percent Revenue Growth in Third Quarter 4.23 Biocept, Rosetta Genomics Partner to Profile microRNAs from CTCs 4.24 Inivata Raises $6.6M to Develop ctDNA Assays 4.25 Epic Sciences Raises $30M in Private Financing 4.26 New Release in Line of Liquid Biopsy CLIA Tests 4.27 Collaborators Publish Data on Resolution Bio Liquid Biopsy Test 4.27 Trovagene's Urine-Based Liquid Biopsy Platform Demonstrated in Field 4.28 FDA Sends Pathway Genomics Untitled Letter Over Liquid Biopsy Test 4.29 DNA in blood can track cancer development, response in real time 4.30 Cynvenio Clinical Trial Supports Multi-Template Liquid Biopsy Sequencing 4.31 Startup AccuraGen to Tap China Liquid Biopsy Market With 61-Gene Assay 4.32 Sysmex Corporation and Clearbridge BioMedics to Jointly Develop New Liquid Biopsy System 4.33 MDxHealth Launches SelectMDx "Liquid Biopsy" Test in the United States 4.34 GATC Biotech's Liquid Biopsy Testing Takes Cost Lead 4.35 Liquid Biotech USA, Inc. Announces Completion of Clinical Study 4.36 Liquid biopsies more effective in some cases than tissue biopsies 4.37 Cancer Genetics, Inc. and ApoCell Announce Partnership for Rare Cell Capture and Detection 4.38 Exosome Diagnostics Launches Liquid Biopsy Test to Rule Out High-Grade Prostate Cancer 4.39 Liquid Biopsy Tests Partially Validated 4.40 FDA Approves Liquid Biopsy 4.41 Liquid Biopsy Predicts Colon Cancer Recurrence 4.42 WaveSense Receives CE-IVD Mark for Cell Enrichment Platform 4.43 For Liquid Biopsy, Size Matters 4.44 Liquid biopsy startup Freenome lands $5.5 million led by Andreessen Horowitz 4.45 Trovagene, USC Collaborate on Deployment of Urine-Based Liquid Biopsy Test 4.46 Circulogene liquid biopsy detects new tumor mass earlier than current imaging methods 4.47 Clinical Utility of Biocept's Liquid Biopsy Platform Demonstrated in Study Results Presented at the 2016 San Antonio Breast Cancer Symposium 4.48 Trovagene to Focus More on Liquid Biopsy Testing Market 4.49 Pancreatic Cancer Gets Prognostic Tool from Liquid Biopsy 4.50 New Start-up to Work on Scalpel-free Liquid Biopsies 4.51 RareCyte announces $30M round 4.52 Liquid Biopsies May Never Replace Tissue Biopsies 4.53 Karius reels in $50M to ramp up infectious disease liquid biopsy 4.54 Liquid Biopsy Passes Test for Nasopharyngeal Cancer 4.55 Exosome Diagnostics Launches the MedOncAlyzer Pan-Cancer Panel 4.56 Lonza Acquires HansaBioMed, Invests in Exosomics 4.57 Controversial Test Highlights Precision Medicine Marketing, Regulatory Issues 4.58 Trovagene Announces Agreement with Global Biopharmaceutical Company 5. Country Market Sizes - North America 6. Country Markets - Europe 7. Country Markets - Asia Pacific 8. Country Markets - Latin America, Africa & The Middle East 9. Global Market Summary 10. Potential Market Opportunity Size For more information about this report visit https://www.researchandmarkets.com/research/88k95t/liquid_biopsy


News Article | September 28, 2017
Site: www.prnewswire.com

The Diagnostic, Monitoring and Screening Test opportunities are explored. A revolution in cancer diagnostics is occurring using in vitro blood testing to identify cancer DNA. The technology creates new markets for cancer screening tests. GRAIL, a new company with impressive backing, has announced a single blood test to detect all cancers. The technology is moving faster than the market. New technology that definitively identifies disease conditions from blood samples is poised to replace expensive invasive surgical biopsy procedures. The market is still in its infancy but has outstanding growth potential. The impact on the health care industry is enormous. The report forecasts the market size out to 2020. In addition, the report looks at potential market sizes by country, by cancer and by the three different opportunities: detection, management and screening. Use independent research that makes you the expert. Get our research team working for you by ordering this comprehensive report. Your credit card order sends the report to your inbox instantly. Check all your licensing options but don't worry, your order is available as a credit if you wish to upgrade to more information. Get an extra player on your team as unlimited assistance and breakout data is included with your purchase. Circulating Tumor Cells? Cell Free DNA? Exosomes? Find out about the technology in readily understood terms that explain the jargon. Find the opportunities and the pitfalls. Understand growth expectations and the ultimate potential market size. The report includes detailed breakouts for 15 Countries and 4 Regions along with breakouts for Lung, Breast, Colorectal, Prostate and Other Cancers. What is the size of the huge screening opportunity? They are all listed in Chapter 10. All report data is available in Excel format on request. Make investment decisions and valuations with confidence using the latest data. i. Liquid Biopsy Market - Strategic Situation Analysis ii. Guide for Executives, Marketing, Sales and Business Development Staff iii. Guide for Management Consultants and Investment Advisors 1. Introduction and Market Definition 1.1 What is Liquid Biopsy? 1.2 The Sequencing Revolution 1.3 Market Definition 1.3.1 Volumes 1.3.2 Prices 1.3.3 Revenue Market Size 1.4 Methodology 1.4.1 Authors 1.4.2 Sources 1.5 A Spending Perspective on Liquid Biopsy 1.5.1 An Historical Look at Clinical Testing 2. Market Overview 2.1 Players in a Dynamic Market 2.1.1 Academic Research Lab 2.1.2 Diagnostic Test Developer 2.1.3 Genomic Instrumentation Supplier 2.1.3.1 Cell Separation and Viewing Instrumentation Supplier 2.1.4 Pharmaceutical/Reagent Supplier 2.1.5 Independent Testing Lab 2.1.6 Public National/regional lab 2.1.7 Hospital lab 2.1.8 Physician Lab 2.1.9 Audit Body 2.1.10 Certification Body 2.2 Using Biopsies 2.2.1 Cancer 2.2.2 Precancerous conditions 2.2.3 Inflammatory conditions 2.3 Biopsy Sites 2.4 The Situation Today - Biopsy Analysis 2.5 Evidence of Cancer - Liquid Biopsy Technology 2.5.1 The Big Picture on Liquid Biopsy Technology 2.5.2 The Role of CTCs 2.5.2.1 Types of CTCs 2.5.2.2 CellSearch Detection- Ultimate Sensitivity 2.5.2.3 Epic Sciences Detection- Imaging Takes the Lead 2.5.2.4 Maintrac Detection - The Microscope 2.5.2.5 Other Methods 2.5.3 ctDNA - Going Mainstream? 2.5.4 Exosomes and Micro Vesicles - New Kid on Block 2.6 Cancer Treatment Protocol Under Siege 2.6.1 Issues and Limitations to Liquid Biopsy Adoption - Double Diagnostics 2.6.2 The Cancer Screening Market Opportunity 2.6.2.1 GRAIL - What Is It? 2.6.3 Cancer Management vs. Diagnosis 2.6.3.1 The Role of Risk Assessment 2.6.3.2 Managing Therapy 2.6.3.3 Monitoring Disease - What Is It? 2.6.4 Phases of Adoption - Looking Into The Future 2.6.5 The Promise of Liquid Biopsy 2.7 Structure of Industry Plays a Part 2.7.1 Hospital Testing Share 2.7.2 Economies of Scale 2.7.2.1 Hospital vs. Central Lab 2.7.3 Physician Office Lab's 2.7.4 Physician's and POCT 2.8 Profiles of Key Players 2.8.1 Qiagen 2.8.2 Agena Bioscience 2.8.3 Angle plc 2.8.4 ApoCell 2.8.5 Biocept 2.8.6 BioFluidica 2.8.7 Bio-Rad Laboratories 2.8.8 Boreal Genomics 2.8.10 Chronix Biomedical 2.8.11 Clearbridge BioMedics 2.8.12 Cynvenio 2.8.13 Cytolumina Technologies Corp 2.8.14 CytoTrack 2.8.15 Diagnologix LLC 2.8.16 Epic Sciences 2.8.17 Exosome Diagnostics 2.8.18 Exosome Sciences 2.8.19 Fluidigm Corp 2.8.20 Fluxion Biosciences 2.8.21 Genomic Health 2.8.39 GRAIL 2.8.22 Guardant Health 2.8.23 HansaBiomed 2.8.23 Horizon Discovery 2.8.24 iCellate 2.8.25 Illumina 2.8.26 Inivata 2.8.27 Janssen Diagnostics 2.8.28 Molecular MD 2.8.29 Myriad Genetics 2.8.30 Natera 2.8.31 New Oncology 2.8.32 Personal Genome Diagnostics 2.8.33 RainDance Technologies 2.8.34 Rarecells SAS 2.8.35 Silicon Biosystems 2.8.36 Sysmex Inostics 2.8.37 SRI International 2.8.38 Trovagene 2.8.39 Freenome 3. Market Trends 3.1 Factors Driving Growth 3.1.1 Non Invasive Game Changer 3.1.2 Lower Cost 3.1.3 Greater Accuracy. 3.1.4 Wide Range of Potential Uses 3.1.5 Aging Population 3.2 Factors Limiting Growth 3.2.1 Lower prices 3.2.2 Lack of Standards. 3.2.3 Protocol Resistance. 3.2.4 Initial Adoption Has No Cost Savings 3.3 Instrumentation and Automation 3.3.1 Instruments Key to Market Share 3.3.2 Bioinformatics Plays a Role. 3.4 Diagnostic Technology Development 3.4.1 Next Generation Sequencing Fuels a Revolution 3.4.2 Impact of NGS on pricing 3.4.3 Pharmacogenomics Blurs Diagnosis and Treatment 3.4.4 CGES Testing, A Brave New World 3.4.5 Biochips/Giant magneto resistance based assay 4. Liquid Biopsy Recent Developments 4.1 Recent Developments - Importance and How to Use This Section 4.1.1 Importance of These Developments 4.1.2 How to Use This Section 4.2 Illumina Forms GRAIL to Enable Early Cancer Detection via Liquid Biopsy 4.3 ASCO: Researchers Present Advances, Ongoing Challenges in Liquid Biopsy 4.4 Guardant Health, SWOG Partner on Prospective NSCLC Liquid Biopsy Study 4.5 Qiagen Expands CDx Deal with Tokai; Acquires CTC Assets from AdnaGen 4.6 Biodesix's GeneStrat Liquid Biopsy Lung Cancer Test 4.7 Baylor, TGen Collaborate on Personalized Cancer Treatment Options 4.8 Liquid Biopsy Firm Resolution Bio Gets CLIA Certification for Lab 4.9 Broad Institute Lands $10M Gift to Study Cancer Drug Resistance 4.10 Biocept Q1 Revenues Rise With Test Volume Growth 4.11 CRUK Manchester Institute Joins European Consortium Validating Blood-based Cancer Biomarkers 4.12 New Oncology Closes Financing Round to Promote Genetic Testing from Blood 4.13 Cynvenio to present new clinical data 4.14 EKF, Angle Collaborate for Liquid Biopsy Development 4.15 Trovagene Collaborates with UCSD for EGFR Monitoring in Lung Cancer 4.16 AstraZeneca Initiates CDx Partnerships with Roche, Qiagen 4.17 Horizon, LGC Awarded Research Grant for Cancer Diagnostics 4.18 Merck Serono and Sysmex Inostics Announce Testing Center 4.19 Agena Bioscience Launches Smaller Format MassArray 4.20 Personal Genome Diagnostics Aims for FDA Clearance 4.21 HTG Molecular Diagnostics Files for IPO of up to $60M 4.22 Genomic Health Reports 5 Percent Revenue Growth in Third Quarter 4.23 Biocept, Rosetta Genomics Partner to Profile microRNAs from CTCs 4.24 Inivata Raises $6.6M to Develop ctDNA Assays 4.25 Epic Sciences Raises $30M in Private Financing 4.26 New Release in Line of Liquid Biopsy CLIA Tests 4.27 Collaborators Publish Data on Resolution Bio Liquid Biopsy Test 4.27 Trovagene's Urine-Based Liquid Biopsy Platform Demonstrated in Field 4.28 FDA Sends Pathway Genomics Untitled Letter Over Liquid Biopsy Test 4.29 DNA in blood can track cancer development, response in real time 4.30 Cynvenio Clinical Trial Supports Multi-Template Liquid Biopsy Sequencing 4.31 Startup AccuraGen to Tap China Liquid Biopsy Market With 61-Gene Assay 4.32 Sysmex Corporation and Clearbridge BioMedics to Jointly Develop New Liquid Biopsy System 4.33 MDxHealth Launches SelectMDx "Liquid Biopsy" Test in the United States 4.34 GATC Biotech's Liquid Biopsy Testing Takes Cost Lead 4.35 Liquid Biotech USA, Inc. Announces Completion of Clinical Study 4.36 Liquid biopsies more effective in some cases than tissue biopsies 4.37 Cancer Genetics, Inc. and ApoCell Announce Partnership for Rare Cell Capture and Detection 4.38 Exosome Diagnostics Launches Liquid Biopsy Test to Rule Out High-Grade Prostate Cancer 4.39 Liquid Biopsy Tests Partially Validated 4.40 FDA Approves Liquid Biopsy 4.41 Liquid Biopsy Predicts Colon Cancer Recurrence 4.42 WaveSense Receives CE-IVD Mark for Cell Enrichment Platform 4.43 For Liquid Biopsy, Size Matters 4.44 Liquid biopsy startup Freenome lands $5.5 million led by Andreessen Horowitz 4.45 Trovagene, USC Collaborate on Deployment of Urine-Based Liquid Biopsy Test 4.46 Circulogene liquid biopsy detects new tumor mass earlier than current imaging methods 4.47 Clinical Utility of Biocept's Liquid Biopsy Platform Demonstrated in Study Results Presented at the 2016 San Antonio Breast Cancer Symposium 4.48 Trovagene to Focus More on Liquid Biopsy Testing Market 4.49 Pancreatic Cancer Gets Prognostic Tool from Liquid Biopsy 4.50 New Start-up to Work on Scalpel-free Liquid Biopsies 4.51 RareCyte announces $30M round 4.52 Liquid Biopsies May Never Replace Tissue Biopsies 4.53 Karius reels in $50M to ramp up infectious disease liquid biopsy 4.54 Liquid Biopsy Passes Test for Nasopharyngeal Cancer 4.55 Exosome Diagnostics Launches the MedOncAlyzer Pan-Cancer Panel 4.56 Lonza Acquires HansaBioMed, Invests in Exosomics 4.57 Controversial Test Highlights Precision Medicine Marketing, Regulatory Issues 4.58 Trovagene Announces Agreement with Global Biopharmaceutical Company 5. Country Market Sizes - North America 6. Country Markets - Europe 7. Country Markets - Asia Pacific 8. Country Markets - Latin America, Africa & The Middle East 9. Global Market Summary 10. Potential Market Opportunity Size For more information about this report visit https://www.researchandmarkets.com/research/53h68b/liquid_biopsy


Jackson J.M.,University of Kansas | Jackson J.M.,Precision for Medicine | Witek M.A.,University of Kansas | Witek M.A.,Precision for Medicine | And 5 more authors.
Chemical Society Reviews | Year: 2017

We present a critical review of microfluidic technologies and material effects on the analyses of circulating tumour cells (CTCs) selected from the peripheral blood of cancer patients. CTCs are a minimally invasive source of clinical information that can be used to prognose patient outcome, monitor minimal residual disease, assess tumour resistance to therapeutic agents, and potentially screen individuals for the early diagnosis of cancer. The performance of CTC isolation technologies depends on microfluidic architectures, the underlying principles of isolation, and the choice of materials. We present a critical review of the fundamental principles used in these technologies and discuss their performance. We also give context to how CTC isolation technologies enable downstream analysis of selected CTCs in terms of detecting genetic mutations and gene expression that could be used to gain information that may affect patient outcome. © 2017 The Royal Society of Chemistry.


Battle K.N.,Louisiana State University | Jackson J.M.,University of North Carolina at Chapel Hill | Witek M.A.,University of North Carolina at Chapel Hill | Hupert M.L.,University of North Carolina at Chapel Hill | And 6 more authors.
Analyst | Year: 2014

We present a novel microfluidic solid-phase extraction (μSPE) device for the affinity enrichment of biotinylated membrane proteins from whole cell lysates. The device offers features that address challenges currently associated with the extraction and purification of membrane proteins from whole cell lysates, including the ability to release the enriched membrane protein fraction from the extraction surface so that they are available for downstream processing. The extraction bed was fabricated in PMMA using hot embossing and was comprised of 3600 micropillars. Activation of the PMMA micropillars by UV/O3 treatment permitted generation of surface-confined carboxylic acid groups and the covalent attachment of NeutrAvidin onto the μSPE device surfaces, which was used to affinity select biotinylated MCF-7 membrane proteins directly from whole cell lysates. The inclusion of a disulfide linker within the biotin moiety permitted release of the isolated membrane proteins via DTT incubation. Very low levels (∼20 fmol) of membrane proteins could be isolated and recovered with ∼89% efficiency with a bed capacity of 1.7 pmol. Western blotting indicated no traces of cytosolic proteins in the membrane protein fraction as compared to significant contamination using a commercial detergent-based method. We highlight future avenues for enhanced extraction efficiency and increased dynamic range of the μSPE device using computational simulations of different micropillar geometries to guide future device designs. © 2014 The Royal Society of Chemistry.


Battle K.N.,Louisiana State University | Uba F.I.,University of North Carolina at Chapel Hill | Soper S.A.,Louisiana State University | Soper S.A.,University of North Carolina at Chapel Hill | And 2 more authors.
Electrophoresis | Year: 2014

The development of fully automated and high-throughput systems for proteomics is now in demand because of the need to generate new protein-based disease biomarkers. Unfortunately, it is difficult to identify protein biomarkers that are low abundant when in the presence of highly abundant proteins, especially in complex biological samples such as serum, cell lysates, and other biological fluids. Membrane proteins, which are in many cases of low abundance compared to the cytosolic proteins, have various functions and can provide insight into the state of a disease and serve as targets for new drugs making them attractive biomarker candidates. Traditionally, proteins are identified through the use of gel electrophoretic techniques, which are not always suitable for particular protein samples such as membrane proteins. Microfluidics offers the potential as a fully automated platform for the efficient and high-throughput analysis of complex samples, such as membrane proteins, and do so with performance metrics that exceed their bench-top counterparts. In recent years, there have been various improvements to microfluidics and their use for proteomic analysis as reported in the literature. Consequently, this review presents an overview of the traditional proteomic-processing pipelines for membrane proteins and insights into new technological developments with a focus on the applicability of microfluidics for the analysis of membrane proteins. Sample preparation techniques will be discussed in detail and novel interfacing strategies as it relates to MS will be highlighted. Lastly, some general conclusions and future perspectives are presented. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Kamande J.W.,Louisiana State University | Hupert M.L.,BioFluidica LLC | Hupert M.L.,University of North Carolina at Chapel Hill | Witek M.A.,University of North Carolina at Chapel Hill | And 12 more authors.
Analytical Chemistry | Year: 2013

In this manuscript, we discuss the development and clinical use of a thermoplastic modular microsystem for the high-throughput analysis of CTCs directly from whole blood. The modular system offers some innovative features that address challenges currently associated with many CTC platforms; it can exhaustively process 7.5 mL of blood in less than 45 min with recoveries >90%. In addition, the system automates the postselection CTC processing steps and thus, significantly reduces assay turnaround time (from selection to enumeration <1.5 h as compared to >8 h for many reported CTC platforms). The system is composed of 3 functional modules including (i) a thermoplastic CTC selection module composed of high aspect ratio (30 μm × 150 μm) channels containing anti-EpCAM antibodies that is scalable in terms of throughput by employing channel numbers ranging from 50 to 320; the channel number is user selected to accommodate the volume of blood that must be processed; (ii) an impedance sensor module for label-less CTC counting; and (iii) a staining and imaging module for the placement of released cells into a 2D array within a common imaging plane for phenotypic identification. To demonstrate the utility of this system, blood samples from patients with local resectable and metastatic pancreatic ductal adenocarcinoma (PDAC) were analyzed. We demonstrate the ability to select EpCAM positive CTCs from PDAC patients in high purity (>86%) and with excellent yields (mean = 53 CTCs per mL for metastatic PDAC patients) using our modular system. In addition, we demonstrate the ability to detect CTCs in PDAC patients with local resectable disease (mean = 11 CTCs per mL). © 2013 American Chemical Society.


Patent
Hoffmann-La Roche, University of North Carolina at Chapel Hill and Biofluidica Inc | Date: 2013-11-08

This invention provides methods and compositions for capturing circulating tumor cells (CTCs) as well as various divergent CTC phenotypes using seprase-specific affinity reagents. Methods of analyzing CTCs and assessing their metastatic potential in vivo and in vitro are also disclosed.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 399.68K | Year: 2015

DESCRIPTION provided by applicant Epithelial Ovarian Cancer EOC is the th leading cause of cancer related deaths among women in the US and is the leading gynecological cancer killer with cases reported in EOC has been called a andquot silent killerandquot because most women andgt are diagnosed at late stages of disease due to a lack of clinically sensitive and specific screening test and a lack of symptoms until late stage disease onset While the incidence rate of EOC in the US is highest among white females there exists a dramatic disparity in post diagnosis outcomes in other populations with African American women exhibiting substantially greater mortality based on year survival rates A combination of insufficient early detection strategies as well as reduced access to surgical treatment required at later stages of disease appears to contribute to the disparity Improved access to advanced screening assays and thereby earlier detection is therefore urgently needed to improve outcomes particularly in disparately effected populations Analysis of circulating tumor cells CTCs from cancer patientsandapos blood have demonstrated prognostic value in metastatic cancers but the use of CTCs for diagnosing early stage disease requires a degree of sensitivity and specificity currently unavailable in existing CTC analysis technologies An innovative CTC detection technology will emanate from this SBIR research project that will have unique capabilities suited to the early detection of EOC and potentially other cancers as well The technology uses low cost disposable plastic CTC fluidic cartridge that possess the ability to select CTCs directly from whole blood with extremely high recoveries andgt unprecedented purities andgt and can enumerate the captured CTCs using a label less approach with a simple single cell transducer micro CTC Coulter Counter C The technology provides a simple workflow with full process automation ideal for a screening test that can be utilized within resource limited settings The technology will process whole blood directly mL input and affinity select the CTCs release the CTCs from the capture surface and count them using an on chip C Unique to our platform is the ability to select different CTCs subpopulations from a single sample BioFluidica has tested its capture system using a novel CTC isolation antigen which as the preliminary data indicates is more prevalent in early stage disease compared to the more commonly used selection target epithelial cell adhesion molecule EpCAM The ability to capture multiple stage specific CTC subpopulations has the potential to diagnose patients at early stages of disease as well as assess treatment efficacy and the potential for disease recurrence The goal of this proposal is to initiate the development of a powerful EOC screening test accelerating treatment and improving currently poor prognoses especially in disparately affected African American women Successful completion of this Phase I program will provide the impetus to move the technology into early detection scenarios for other cancers that show disparities such as breast cancer in African American women PUBLIC HEALTH RELEVANCE Epithelial ovarian cancer EOC exhibits the th highest mortality rate amongst women in the US While its incidence rate is higher among white women epidemiological data reports a significant reduction in the year survival rates for African American women While new screening assays are broadly required to detect early stage disease an automated cost effective and accurate test has the best chance of improving the disparate mortality rates in various populations This project is focused on developing a transformative technology that can serve as a screening test which isolates circulating tumor cells CTCs from blood samples to diagnose early stage EOC appropriate for ethnic groups with EOC health disparities


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2015

DESCRIPTION provided by applicant Multiple myeloma MM is a plasma cell malignancy and comprises about of malignant tumors and of all hematopoietic neoplasms According to the American Cancer Society in an estimated new cases were diagnosed in the U S with the estimated deaths being Monoclonal gammopathy of undetermined significance MGUS is associated with a per year risk of progression to overt malignancy most commonly MM and is found in approximately of individuals over with the prevalence increasing with age Without a clear diagnostic test to monitor MGUS malignancy progression a range of factors are currently monitored including changes in serum free light chains ratio elevated serum M protein level and high bone marrow plasma cell percentage Recent studies have demonstrated that circulating multiple myeloma cells CMMCs secured from bone marrow biopsies measured by immuno uorescence microscopy or ow cytometry are useful for diagnosis prognosis and measuring therapeutic response for MM However securing a bone marrow biopsy is painful to the patient prohibiting frequent testing required for monitoring disease progression drug response and or recurrence Development of novel instrumentation and techniques for CMMC selection and analysis directly from peripheral blood is essential to improve the management of patients with MM or its early disease stages Building on extensive preliminary data secured from a Phase I type study this Phase II project is focused on the development of an integrated system that uses a disposable fluidic cartridge and the associated instrument peripherals for the rapid and fully automated processing of CMMCs directly from whole blood obviating the need for bone marrow biopsies and thus allowing for more frequent testing especially those with MGUS The instrument will be able to select CMMCs at andgt recovery and andgt purity release the selected cells and electronically enumerate them and prepare them for FISH analysis or immunophenotyping The system can also off load the selected CMMCs for molecular profiling such as searching for KRAS mutations Operation of the instrument will be automated with an overall sample to answer processing time of h The system will be subjected to both internal validation by BioFluidica staff as well as external validation by collaborators at the University of North Carolina at Chapel Hill While MM will be used as a case study for clinical performance verification of the instrument it can easily be utilized in different cancer related diseases by programming in the correct selection antibody to search for the relevant blood borne biological cells PUBLIC HEALTH RELEVANCE Building on BioFluidicaandapos s Inc experiences for analyzing circulating tumor cells CTCs this project will generate an innovative system for the analysis of circulating multiple myeloma cells CMMCs directly from peripheral blood for all stages of the disease including the early monoclonal gammopathy of undetermined significance MGUS to symptomatic multiple myeloma The project outcome will be an automated system for the analysis of CMMCs including enumeration molecular profiling and fluorescence in situ hybridization with translation into clinical settings for securing data pertinent to future FDA clearance and or implementation in CLIA laboratories enabling oncologists to obtain valuable diagnostic information currently not available on multiple myeloma

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