European Clinical Laboratory, Molecular Diagnostics and Genomic Testing Services Market 2015-2019: Next Generation Sequencing and new Molecular Diagnostics Tests drive market growth while lowering costs


Dublin, May 05, 2015 (GLOBE NEWSWIRE) -- Research and Markets (http://www.researchandmarkets.com/research/pmd597/clinical) has announced the addition of the "Clinical Laboratory, Molecular Diagnostics and Genomic Testing Services Market Trends and Forecasts 2015 to 2019 - Europe Version" report to their offering.

A market that just keeps on growing. Clinical laboratory testing is positioned to directly benefit from the explosion in biotechnology, especially genomics. A range of dynamic trends are pushing market growth and company valuations.

Trends like:

- changing demographics
- emerging economies and global prosperity
- biotechnology advances in genetics
- pathogen evolution
- climate change
- globalization
- automation

Exciting technical developments especially in the area of molecular diagnostics and pharmacogenics hold the promise of a dynamic, growing and evolving world market that is moving out of the national and regional orientation and onto a global stage.

"Clinical Laboratory, Molecular Diagnostic and Genomic Testing Services - 2015 to 2019" provides data that analysts and planners can use. Hundreds of pages of information including a complete list of Current 2015 United States Medicare Fee Payment Schedules to help sharpen your pricing. Make facilities planning decisions. Forecast demand for new testing regimes or technologies. Make research investment decisions. Based on extensive primary and secondary research the testing volume data is broken down into price and volumes allowing researchers and investors to quickly create informed and reasonable forecasts of demand. 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.

Key Topics Covered:

1. Introduction and Market Definition
1.1 Introduction
1.2 Market Definition
1.2.1 Volumes
1.2.2 Prices
1.2.3 Revenue Market Size
1.3 Methodology
1.3.1 Authors
1.3.2 Sources
1.4 U.S. Medical Market and Clinical Laboratory Testing - Perspective
1.3.1 U.S. Medicare Expenditures for Clinical Testing

2. Market Overview
2.1 Market Participants
2.1.1 Supplier/pharmaceutical
2.1.2 Independent lab specialized/esoteric
2.1.3 Independent lab national/regional
2.1.4 Independent lab analytical
2.1.5 Public National/regional lab
2.1.6 Hospital lab
2.1.7 Physician lab
2.1.8 Audit body
2.2 Market Segments
2.2.1 Traditional Market Segmentation
2.2.2 Laboratory Focus and Segmentation
2.3 Industry Structure
2.3.1 Hospital Testing Share
2.3.2 Economies of Scale
2.3.3 Physician Office Lab's
2.3.4 Physician's and POCT
2.4 Profiles of Key Companies
2.4.1 Quest Diagnostics
2.4.2 Laboratory Corporation of America
2.4.3 Lifelabs Medical Laboratory Services
2.4.4 ACM Medical Laboratory
2.4.5 Spectra Spectra Laboratories, Inc.
2.4.6 Bio-Reference Laboratories, Inc.
2.4.7 Signal Genetics LLC
2.4.8 CompuNet Clinical Laboratories, LLC
2.4.9 Genzyme Corporation
2.4.10 Sonic Healthcare Limited
2.4.11 Exagen Diagnostics, Inc.
2.4.12 Clongen Laboratories LLC
2.4.13 Clinical Reference Laboratory, Inc.
2.4.14 Rosetta Genomics Inc.
2.4.15 Mid America Clinical Laboratories, LLC
2.4.16 Alere Inc
2.4.17 Caris Life Sciences, Inc.
2.4.18 Psychemedics Corp.
2.4.19 Aurora Diagnostics, LLC
2.4.20 DL Reference Laboratory
2.4.21 Myriad Genetics, Inc.
2.4.22 Bioscientia Institut fuer Medizinische Diagnostik GmbH
2.4.23 Acibadem Labmed Laboratory
2.4.24 Claymon Biomnis Laboratories Ltd.
2.4.25 Biomnis (France)
2.4.26 The Doctor's Laboratory (Sonic Healthcare U.K.)
2.4.27 Pathology Inc.
2.4.28 Gribbles Pathology
2.4.29 BP Lab
2.4.30 Adicon Clinical Laboratories, Inc.
2.4.31 Diagnósticos da América (DASA)
2.4.32 Medicus Phillipines Inc.
2.4.33 Kingmed Diagnostics
2.4.34 Ascend Clinical, LLC
2.4.35 Unilabs SA
2.4.36 American Pathology Partners, Inc.
2.4.37 Centrex Clinical Laboratories, Inc.
2.4.38 Integrated Regional Laboratories, Inc.
2.4.39 Vira Cor-Ibt Laboratories
2.4.40 Clarient, Inc.
2.4.41 Genomic Health, Inc.
2.4.42 ARUP Laboratories, Inc.
2.4.43 MEDTOX Scientific, Inc.
2.4.44 Solstas Lab Partners
2.4.45 Predictive Biosciences, Inc.
2.4.46 Enzo Biochem, Inc.
2.5 National and Regional Diversity

3. Market Trends
3.1 Factors Driving Growth
3.1.1 Impact of U.S. Health Reform (PPACA) on U.S. Market
3.1.2 Understanding the Impact of Aging Population.
3.1.3 Economic growth drives health spending.
3.1.4 Point of Care Testing can increase demand
3.1.5 Wellness concerns create growth
3.1.6 Esoteric Testing Moving Mainstream
3.1.7 Genetic Based Testing Creates New Department and New Discipline
3.2 Factors Limiting Growth
3.2.1 Lower costs trend to continue
3.2.2 Economic or population contraction.
3.2.3 Testing usage analysis curtailing growth.
3.2.4 Wellness has a downside
3.2.5 Test Displacement Impacts Important
3.2.6 Point of Care Testing
3.3 Automation
3.3.1 Stranded LIMS Investment
3.3.2 Software as a Service
3.3.3 Physician Office and Access Systems
3.4 Environment and Evolution
3.5 Diagnostic Technology Development
3.5.1 Next Generation Sequencing Fuels a Revolution
3.5.2 Impact of NGS on pricing
3.5.3 POCT/Self Testing Disruptive Force
3.5.4 Pharmacogenomics Blurs Diagnosis and Treatment
3.5.5 CGES Testing, A Brave New World
3.5.6 Molecular Diagnostics Technologies At The Forefront of Growth
3.5.7 Biochips/Giant magneto resistance based assay

4. Laboratory, Molecular Diagnostics and Genomic Testing 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 Quest Diagnostics completes acquisition of Concentra's clinical laboratory business
4.3 CollabRx and GeneInsight to Collaborate on Service for Clinical Genetic Sequencing
4.4 Cinven, KKR, Warburg to place second-round bids for PRA
4.5 Thermo Fisher to buy Life Technologies in $15.8bn deal
4.6 DiaTech Oncology looks to invest in TN medical lab
4.7 US FDA Looks to Regulate Laboratory-Developed Diagnostic Tests
4.8 Riverside Invests in BioAgilytix Labs
4.9 CardioDx Receives College of American Pathologists (CAP) Accreditation
4.10 LipoScience To Provide Lipoprotein Analysis For Cardiovascular Disease Management
4.11 DiaTech Oncology Announces Capital Raise of $18 Million
4.12 Inostics' Lab Gains CLIA Licensure
4.13 Community Clinical Lab Companies Hard Hit by Medicare Lab Test Fee Cuts
4.14 Fast Home Colon Cancer Test in Development
4.15 Point-of-Care Testing Device Detects MicroRNA in 20 Minutes
4.16 Cerner Corporation Acquiring Labotix Automation Inc.
4.17 Johnson & Johnson May Spin Off Ortho Clinical Diagnostics Unit
4.18 Illumina Using Acquisitions to Challenge Roche
4.19 Quest Diagnostics to Acquire Umass Clinical Laboratory Business
4.20 Roche Diagnostics to Invest $300 Million to Support Clinical Lab Testing Business
4.21 Quest Diagnostics to Acquire Lab-Related Clinical Outreach Operations of Dignity Health
4.22 US university to create world class pathology lab in Hyderabad
4.23 LifeLabs Announces Agreement to Acquire CML HealthCare Inc.
4.24 LifeLabs Completes Purchase of BC Biomedical Laboratories
4.25 Matrix-Bio Inks Deal With Purdue for Cancer Diagnostics
4.26 Quest Diagnostics and Hologic Team Up on Women's Health Tests
4.27 Siemens to Create Companion Diagnostic for Janssen Heart Failure Drug
4.28 Proteome Sciences, Fisher Scientific Sign Agreement on Cancer Tests
4.29 Genisphere Licenses Signal Amplification Technology to Chembio
4.30 Life Technologies, Merck Serono Form Co-Diagnostics Partnership
4.31 Cell Signaling Technology, Cepheid Collaborate on Lung Cancer Test
4.32 PAML Forms Collaboration With Cleveland Clinic Laboratories
4.33 Bio-Reference to Maintain Free Genetic Laboratory Service
4.34 Cornell Licenses Prostate Cancer Biomarker to Empire Genomics
4.35 BioHelix Acquired by Quidel
4.36 Quest Buys Concentra Lab and Toxicology Services
4.37 Arno Therapeutics, Veridex to Develop Anti-Progestin Co-Diagnostic
4.38 Qiagen Enters Two Licensing Agreements for Cancer Biomarkers
4.39 OHSU and Intel to Collaborate on Computing Solutions for Genomic Analysis
4.40 Qiagen Inks Deal to Buy Ingenuity Systems
4.41 NanoString Acquires Liver Cancer Gene Signature From Broad Institute
4.42 CvergenX, NCI Work to Develop Predictive Test for Radiation Therapy Success
4.43 Brigham and Women's Hospital Joins NINDS Parkinson's Biomarkers Search
4.44 Thermo Fisher Buys Life Technologies
4.45 OGT Signs Licensing Agreement for ICR Prostate Cancer Biomarkers
4.46 Quest and PrimeraDx Ink Co-Diagnostics Deal
4.47 OpGen Files for IPO for up to $37M
4.48 Transgenomic Closes Public Offering of Stock, Warrants
4.49 Qiagen Discloses $114.2M Price Tag for Enyzmatics Acquisition
4.50 Laboratory Corporation of America Holdings Full Year Results
4.51 GenomeDx Biosciences Implements Clarity LIMS
4.52 Merck Serono and Sysmex Inostics Announce Testing Center
4.53 Lifecode Receives CAP Accreditation, Discloses Funding
4
4.55 23andMe Gets FDA Clearance to Market Bloom Syndrome Carrier Test
4.56 LabCorp to Buy Covance for $6.1 Billion to Add Drug R&D
4.57 Trinity Biotech Revenues Grow by 15%
4.58 Google's Latest Healthcare Initiative
4.59 Trinity Biotech Announces US Clinical Trials
4.60 Agena Bioscience Launches Smaller Format MassArray
4.61 QuantRx® Biomedical Provides Update on Technological Progress
4.62 The Journal of Molecular Diagnostics Publishes Special Article
4.63 Caprion Licenses Indi's Xpresys as Part of Larger Clinical Push
4.64 MDxHealth's ConfirmMDx Genes Detect Prostate Cancer
4.65 Atossa Genetics Announces That Its Subsidiary The National Reference Laboratory for Breast Health Has Received Accreditation
4.66 Nuclea Bio Plans Entry into Clinical Proteomics
4.67 Personal Genome Diagnostics Aims for FDA Clearance
4.68 Enzo Biochem Announces New Molecular Platform
4.69 Multiplicom, Premaitha Develop CE-IVDs
4.70 Regulating the Next Generation of Genetic Testing
4.71 BioReference Laboratories, Inc. Launches an Advanced Tumor Sequencing Program
4.72 Cytogenetics Become First Certified Lab to Offer Microarray Testing
4.73 Results Support Clinical Validity of Quantose IGT(TM) Diabetes Test
4.74 Accelerate Diagnostics' 2014 Revenues Rise Sharply
4.75 NanoString's Q4 Revenues Jump 54 Percent
4.76 New Aussie Firm Life Letters Launches Carrier, PGx Testing for Consumers
4.77 HTG Molecular Reports 50 Percent Increase in 2014 Revenues
4.79 LabCorp Posts 5 Percent Revenue Growth
4.80 Genomic Vision, Quest Extend Pact for Molecular Combing Technology
4.81 ACT Genomics Raises $8M in Private Funding Round
4.82 NGS-based Cancer MDx Firm Lifecode Raises $20.5M, Receives CAP Accreditation
4.83 Invitae Goes Public with $101.6M Offering
4.84 Quidel Q4 Revenues Grow 27 Percent on Infectious Disease Sales
4.85 Rosetta Signs Deal to Promote Precipio's Cancer Diagnostics
4.86 Premaitha Iona NIPT Lands CE Mark
4.87 Sera Increases Series B Round to $25M with $5M from Gates Foundation
4.88 T2 Biosystems Inks $8.5M Lyme Disease Dx Deal with Canon US Life Sciences
4.89 Invitae Amends IPO Filing Targeting up to $92.3M
4.90 Biofortuna Closes $2.2M Funding Round
4.91 Roche MDx Sales Help Drive 2014 Diagnostics Revenues up 3 Percent
4.92 AltheaDx Increases Target Amount on Proposed IPO to $74.3M
4.93 BioMerieux 2014 Revenues Increase 7 Percent
4.94 Cypher Genomics and Sequenom Announce Development Agreement
4.95 Abcam to Acquire Firefly BioWorks for $28M
4.96 PerkinElmer Opens Medical Laboratory in China
4.97 Human Longevity, Genentech Ink Deal to Sequence Thousands of Genomes
4.98 GenMark Projects 52 Percent Growth in Q4 Revenues
4.99 Amarantus Acquires DioGenix for up to $10.9M
4.100 Roche to Invest up to $1.2B in Foundation Medicine, Take Majority Stake
4.101 DiaCarta Raises $8M in Series A Round
4.102 Epic Sciences' Cancer Dx Laboratory Receives CLIA Certification
4.103 Adaptive Biotechnologies Acquires Sequenta
4.104 Aegis Sciences Acquires MDx Firm Diagnovus
4.105 Interleukin Genetics Secures $10M in Financing
4.106 Premaitha NIPT Test Receives ISO Certification
4.107 HTG Molecular Diagnostics Files for IPO of up to $60M
4.108 CardioDx Raises $35M
4.109 MolecularMD Receives CAP Accreditation
4.110 14M Genomics Secures £12.5M Equity Financing for Oncology Dx
4.111 Protagen Closes First Part of Financing Round
4.112 Glyconics Inks Exclusive Licensing Deal
4.113 Great Basin Scientific Begins Trial for Staph Assay
4.114 Response Genetics Receives NYS Approval for Cancer Test
4.115 Claritas Genomics Adopts NextCode Health Platform to Interpret NGS Tests
4.116 FDA Clears Quidel's MDx for Bordetella Pertussis
4.117 FDA Clears Additional Flu Strains for Focus' MDx Assay
4.118 Novacyt Raises $3.8M in Private Equity
4.119 Good Start Genetics Licenses PGS Technology from Johns Hopkins
4.120 Metamark's Cambridge Lab Receives CAP Accreditation
4.121 Australia's VCGS Inks Deal with Illumina to Develop NIPT
4.122 LabCorp Acquires Bode Technology
4.123 Personalized Medicine Firm Newtopia Garners Investment from Bloom Burton
4.124 Roche to Acquire Ariosa Diagnostics
4.125 CMS Issues Final Payment Decision
4.126 MDx Firm Curetis Closes $18M Series B Extension
4.127 Australia's Proteomics International Laboratories Launches A$6M IPO
4.128 Australian MDx Firm Genetic Signatures Eyes IPO for up to A$15M
4.129 N-of-One to Support Oncology Testing at BloodCenter of Wisconsin
4.130 Signal Genetics Q3 Revenues Move up 32 Percent
4.131 Sequenta, Illumina Strike IVD Deal
4.132 Veracyte Q3 Revenues Spike 75 Percent
4.133 Great Basin's Q3 Revenues Jump 83 Percent
4.134 Response Genetics Q3 Revenues Improve 9 Percent
4.135 Roche Gets FDA Clearance for Strep A MDx Test
4.136 GeneNews Q3 Revenues up Sharply
4.138 Epigenomics Q3 Revenues Grow 7 Percent
4.139 CareDx Q3 Revenues up 16 Percent
4.140 Exagen Records Sharp Increase in Revenues for First Nine Months of 2014
4.141 CollabRx, Cartagenia Partner to Provide Cancer Testing
4.142 Prostate Management Dx Closes $1.1M Series A Financing
4.143 Roka Bioscience Posts Jump in Q3 Revenues
4.144 Pacific Biosciences Files $150M Shelf Registration
4.155 Foundation Medicine Doubles Q3 Revenues
4.156 Nanosphere Q3 Revenues Climb 54 Percent
4.157 Hologic Fiscal Q4 Revenues Increase 6 Percent
4.158 MDxHealth Raises $15.4 Million in Private Stock Offering
4.159 Genomic Health Reports 5 Percent Revenue Growth in Third Quarter
4.160 NanoString Posts 47 Percent Q3 Revenue Growth
4.161 AstraZeneca's MedImmune Acquiring Definiens for at Least $150M
4.162 PDI Acquires MDx Firm RedPath Integrated Pathology
4.163 GenMark Q3 Revenues Rise 37 Percent
4.164 NeoGenomics Q3 Revenues Increase 37 Percent
4.165 Qiagen Q3 Revenues Rise 4 Percent
4.166 LabCorp Q3 Revenues Rise 6 Percent
4.167 Luminex Q3 Revenues Jump 12 Percent on Assay Sales
4.168 Nanosphere Closes $18.4M Stock Offering
4.169 Pacific Biosciences Q3 Revenues Climb 178 Percent
4.170 Abbott Posts Q3 Revenues Increase of 6 Percent
4.171 Quidel Q3 Revenues Grow 22 Percent
4.172 Clinical Genomics, CSIRO Sign Licensing Deal for Bowel Cancer MDx
4.173 Illumina Posts 35 Percent Increase in Q3 Sales
4.174 Epigenomics Raises $5.3M
4.175 BGI Dx, Bioscience Genomics Ink NIPT Deal
4.176 Natera Preps Move into Cancer Dx Market
4.177 BioTheranostics Gets Medicare Coverage for Breast Cancer Index Test
4.178 Quidel Gets FDA Clearance for HPIV Test
4.179 NextGxDx Adds $2.2M to Series B Financing
4.180 Invitae Completes $120M Series F Financing
4.181 Quidel Gets FDA OK for Adenovirus MDx
4.182 Nanosphere Gets FDA OK for Additional Targets on Enteric Pathogens MDx Test
4.183 Biocept, Rosetta Genomics Partner to Profile microRNAs from CTCs
4.184 Great Basin Scientific Prices IPO
4.185 Abbott Receives CE Mark for TB MDx
4.186 AutoGenomics Seeks to Raise $60M in IPO
4.187 Sequenom Buys NIPT Intellectual Property from Isis for $14.6M
4.188 Adarza BioSystems Raises $6.8M in Series A Round
4.189 NantHealth Adds $250M to Financing Round
4.190 Cepheid Buys Labsco Customer Relationships for $21M
4.191 NYDOH Approves AltheaDx's PGx Test Suite
4.192 Mayo Clinic, Invenshure Launch Oneome
4.193 Mobidiag Bacterial Gastroenteritis Assay Gets CE Mark
4.194 Inivata Raises $6.6M to Develop ctDNA Assays
4.195 Exagen Files for $69M IPO
4.196 American Liberty Petroleum to Acquire Avant Diagnostics
4.197 Vermillion Files $50M Shelf Registration
4.198 Advanced Cell Diagnostics Establishing European Subsidiary
4.199 Australia's Genetic Technologies Restructures to Focus on US MDx Space
4.200 Biocartis Obtains CE-IVD Mark for MDx Platform, BRAF Mutation Test
4.201 Veracyte to Buy Allegro Dx for $21M
4.202 HTG Molecular to Raise $800K in Private Financing
4.203 LabCorp Launches Clinical Sequencing Business, Enlighten Health Genomics
4.204 Biocartis Raises $84M, Forms JV with Pronota
4.205 Chinese Regulators Approve AmoyDx's ALK, ROS1 Gene Fusion Detection Kits
4.206 Cepheid Trichomoniasis Test Gets CE-IVD Mark
4.207 BioMerieux Logs 4 Percent Organic Growth in 1H 2014
4.208 Rosetta Genomics, Moffitt Cancer Center to Collaborate
4.209 NGS Clinical Dx Firm Blueprint Genetics Raises Funds
4.210 NanoString Files $100M Shelf Registration
4.211 HTG Molecular Secures $16M Debt Facility
4.212 CareDx Posts 24 Percent Q2 Revenue Growth
4.213 Pacific Edge, SCPMG to Evaluate Bladder Cancer Dx
4.214 BioReference Laboratories Reports 20 Percent Jump in Q3 Revenues
4.215 NeoGenomics Closes $34.6M Public Offering
4.216 MDxHealth Posts 20 Percent Increase in H1 2014 Revenues
4.217 Source BioScience Posts 46 Percent Revenue Growth in H1 2014
4.218 BHC Invests in 20/20 GeneSystems to Bring Lung Cancer Test to China
4.219 Toronto's Mount Sinai Services Lab Receives Quality Accreditation
4.220 Signal Genetics Reports 18 Percent Increase in Q2 Revenues
4.221 PDI Moves into MDx Space with Acquisition of Two Asuragen microRNA Tests
4.222 Oral Cancer MDx Firm Proteocyte Closes $554K Funding
4.223 Cancer MDx Firm Castle Biosciences Raises $11.8M
4.224 Epigenomics Q2 Revenues Rise 18 Percent
4.225 Caris, Feist-Weiller Cancer Center Partner to Offer Tumor Profiling Services
4.228 GenMark Q2 Revenues Rise 27 Percent
4.229 Roka Bio Q2 Revenues More than Double
4.230 GeneNews Q2 Revenues Increase Sharply on Joint Venture Contribution
4.231 Genomic Health Reports 11 Percent Revenue Jump in Second Quarter
4.232 Trovagene Q2 Revenues Improve 14 Percent, Loss Narrows
4.233 UnitedHealthcare to Reimburse for NanoString's Prosigna Breast Cancer Test
4.234 Leica Developing CDx for Bristol-Myers Squibb Drugs
4.235 PacBio Raises $20.6M through Common Stock Sale
4.236 Ventana, Quintiles to Offer CDx Testing Services in China
4.237 Response Secures $12M Credit Facility
4.238 InformedDNA Nabs $4.5M Investment
4.239 Invitae, Nanopharmacia Partner on Genetic Cancer Testing
4.240 Sequenom Posts 62 Percent Jump in Q2 Revenues
4.241 Epic Sciences Raises $30M in Private Financing
4.242 Intrinsic LifeSciences Awarded $4.45M SBIR Grant for Anemia Test Development
4.243 FDA Clears Quidel's Amplivue Group A Strep Test
4.244 FDA Clears BD Chlamydia, Gonorrhea Assays
4.245 Meridian Bio FY Q3 Sales Inch Up
4.246 Grifols, Hologic Hepatitis E Assay CE Marked
4.247 Contextual Genomics, Personalized Medicine Initiative Launch Project
4.248 Sidra, Illumina Ramping Up High-Throughput Genomics Center in Qatar
4.249 Stratose to Cover CombiMatrix's Microarray Testing Services
4.250 Pressure BioSciences to work with Parabase Genomics
4.251 Epistem, Global Health Investment Fund Ink Collaborative Funding Pact
4.252 OpGen Raises $1.1M
4.253 CareDx Goes Public, Anticipates up to $40M in Net Proceeds
4.254 Roka Goes Public in $60M Stock Offering
4.255 Agendia, CBLPath Collaborate on Breast Cancer MDx
4.256 CombiMatrix Gains Conditional Approval for Pediatric Disorders Array Test
4.257 C2N, WUSTL Expand Partnership to Commercialize Alzheimer's Test
4.258 Xagenic Closes Series B Round Raising $23.8M
4.259 GeneCentric Raises $5M
4.260 Tute Genomics Inks NGS Test Analytics Deal with Lineagen
4.261 Asuragen gets permit to Offer Fragile X, Thyroid Cancer MDx
4.262 FedMed to Cover BioTheranostics Cancer MDx Tests
4.263 NeoGenomics Buys Path Labs for $6M
4.264 Sophia Genetics Raises $13.8M in Private Financing Round
4.265 Genomas, AutoGenomics Partner to Advance Dx to Personalize Statin Treatments
4.266 Aetna Begins Coverage of CardioDx's Coronary Artery Disease Test
4.267 Preconception Genetic Testing Firm GenePeeks Secures $3M Loan
4.268 Empire Genomics Lands $1M Financing
4.269 CompanionDx, RegenWell Sign Deal to Bring Genomics Testing to POC
4.270 Illumina Inks NIPT Deals Covering Parts of Europe
4.271 BioNano Genomics Raises $5M
4.272 New York State Approves Signal Genetics' Myeloma Test
4.273 Provista Receives CAP Accreditation for CLIA Lab
4.274 Bioinn to Distribute Courtagen's NGS Tests in Taiwan
4.275 Bruker Receives China FDA Clearance for IVD MALDI Biotyper
4.276 Cancer Genetics to Buy PGx Firm Gentris for up to $6.25M
4.277 Definiens Raises $20.4M in Private Financing Round
4.278 Courtagen Raises $6.3M
4.279 B. Braun Medical US and CeGaT enter US Market
4.280 Cancer MDx Firm Nucleix Raises $5M
4.281 CareDx Inks Supply Agreement with Illumina
4.282 Sequenom Signs NIPT Deal with Quest
4.283 ViaLogy Acquiring MDx Firm Premaitha Health for $17.8M
4.284 Genomed to Offer BGI's NIPT in Poland
4.285 Newcastle-based QuantuMDx closes funding round
4.286 Enzo Biochem Q3 Revenues Rise 6 Percent
4.287 BD, AITbiotech Ink Distribution Pact for MDx Assays in Asia-Pacific
4.288 BioReference Laboratories Posts 14 Percent Q2 Revenue Growth
4.289 Personalis' Lab Receives CAP Accreditation
4.290 Alliance Global Group, Invivoscribe Ink Distribution Deal

5. Country Markets - Europe
5.1 France
5.1.1 Clinical Chemistry - Volumes, Prices, Revenues
5.1.2 Microbiology - Volumes, Prices, Revenues
5.1.3 Hematology - Volumes, Prices, Revenues
5.1.4 Anatomic Pathology - Volumes, Prices, Revenues
5.1.5 Molecular Diagnostics - Volumes, Prices, Revenues
5.1.6 All Clinical Testing - Volumes, Prices, Revenues
5.1.7 Cardiac Biomarkers - Volumes, Prices, Revenues
5.1.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
5.1.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues
5.2 Germany
5.2.1 Clinical Chemistry - Volumes, Prices, Revenues
5.2.2 Microbiology - Volumes, Prices, Revenues
5.2.3 Hematology - Volumes, Prices, Revenues
5.2.4 Anatomic Pathology - Volumes, Prices, Revenues
5.2.5 Molecular Diagnostics - Volumes, Prices, Revenues
5.2.6 All Clinical Testing - Volumes, Prices, Revenues
5.2.7 Cardiac Biomarkers - Volumes, Prices, Revenues
5.2.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
5.2.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues
5.3 United Kingdom
5.3.1 Clinical Chemistry - Volumes, Prices, Revenues
5.3.2 Microbiology - Volumes, Prices, Revenues
5.3.3 Hematology - Volumes, Prices, Revenues
5.3.4 Anatomic Pathology - Volumes, Prices, Revenues
5.3.5 Molecular Diagnostics - Volumes, Prices, Revenues
5.3.6 All Clinical Testing - Volumes, Prices, Revenues
5.3.7 Cardiac Biomarkers - Volumes, Prices, Revenues
5.3.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
5.3.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues
5.4 Spain
5.4.1 Clinical Chemistry - Volumes, Prices, Revenues
5.4.2 Microbiology - Volumes, Prices, Revenues
5.4.3 Hematology - Volumes, Prices, Revenues
5.4.4 Anatomic Pathology - Volumes, Prices, Revenues
5.4.5 Molecular Diagnostics - Volumes, Prices, Revenues
5.4.6 All Clinical Testing - Volumes, Prices, Revenues
5.4.7 Cardiac Biomarkers - Volumes, Prices, Revenues
5.4.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
5.4.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues
5.5 Italy
5.5.1 Clinical Chemistry - Volumes, Prices, Revenues
5.5.2 Microbiology - Volumes, Prices, Revenues
5.5.3 Hematology - Volumes, Prices, Revenues
5.5.4 Anatomic Pathology - Volumes, Prices, Revenues
5.5.5 Molecular Diagnostics - Volumes, Prices, Revenues
5.5.6 All Clinical Testing - Volumes, Prices, Revenues
5.5.7 Cardiac Biomarkers - Volumes, Prices, Revenues
5.5.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
5.5.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues
5.6 Russia
5.6.1 Clinical Chemistry - Volumes, Prices, Revenues
5.6.2 Microbiology - Volumes, Prices, Revenues
5.6.3 Hematology - Volumes, Prices, Revenues
5.6.4 Anatomic Pathology - Volumes, Prices, Revenues
5.6.5 Molecular Diagnostics - Volumes, Prices, Revenues
5.6.6 All Clinical Testing - Volumes, Prices, Revenues
5.6.7 Cardiac Biomarkers - Volumes, Prices, Revenues
5.6.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
5.6.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues
5.7 Remainder of Europe and Former Soviet Union
5.7.1 Clinical Chemistry - Volumes, Prices, Revenues
5.7.2 Microbiology - Volumes, Prices, Revenues
5.7.3 Hematology - Volumes, Prices, Revenues
5.7.4 Anatomic Pathology - Volumes, Prices, Revenues
5.7.5 Molecular Diagnostics - Volumes, Prices, Revenues
5.7.6 All Clinical Testing - Volumes, Prices, Revenues
5.7.7 Cardiac Biomarkers - Volumes, Prices, Revenues
5.7.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
5.7.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues

6. Global Market Summary
6.1 Global Market
6.1.1 Clinical Chemistry - Volumes, Prices, Revenues
6.1.2 Microbiology - Volumes, Prices, Revenues
6.1.3 Hematology - Volumes, Prices, Revenues
6.1.4 Anatomic Pathology - Volumes, Prices, Revenues
6.1.5 Molecular Diagnostics - Volumes, Prices, Revenues
6.1.6 All Clinical Testing - Volumes, Prices, Revenues
6.1.7 Cardiac Biomarkers - Volumes, Prices, Revenues
6.1.8 Molecular Diagnostic Oncology - Volumes, Prices, Revenues
6.1.9 Molecular Diagnostic Genetics - Volumes, Prices, Revenues

7. The Future of the Clinical Laboratory

Appendices
I. United States Medicare System: January 2015 Clinical Laboratory Fees Schedule - National Limit
and Midpoint



Table of Tables

Table 1 Medicare Clinical Lab Expenditures Actual & Forecast 2004 to 2020 ($Billion)
Table 2 Market Players by Type
Table 3 Clinical Laboratory Departments and Segments
Table 4 Laboratory Management Focus - Different Approaches
Table 5 Key Segmentation Variables Going Forward
Table 6 Factors Affecting Local Clinical Testing Demand
Table 7 Seven Factors Driving Growth
Table 8 Six Factors Limiting Growth
Table 9 Key Diagnostic Laboratory Technology Trends
Table 10 Next Generation Sequencing Technologies - Speed and Cost
Table 11 Key Point of Care Testing Uses
Table 12 Clinical Application Areas for Molecular Diagnostics
Table 31 Clinical Chemistry - Volume Price and Revenue Forecast
Table 32 Microbiology - Volume Price and Revenue Forecast
Table 33 Hematology - Volume Price and Revenue Forecast
Table 34 Anatomic Pathology - Volume Price and Revenue Forecast
Table 35 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 36 All Clinical Testing - Volume Price and Revenue Forecast
Table 37 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 38 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 39 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 40 Clinical Chemistry - Volume Price and Revenue Forecast
Table 41 Microbiology - Volume Price and Revenue Forecast
Table 42 Hematology - Volume Price and Revenue Forecast
Table 43 Anatomic Pathology - Volume Price and Revenue Forecast
Table 44 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 45 All Clinical Testing - Volume Price and Revenue Forecast
Table 46 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 47 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 48 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 49 Clinical Chemistry - Volume Price and Revenue Forecast
Table 50 Microbiology - Volume Price and Revenue Forecast
Table 51 Hematology - Volume Price and Revenue Forecast
Table 52 Anatomic Pathology - Volume Price and Revenue Forecast
Table 53 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 54 All Clinical Testing - Volume Price and Revenue Forecast
Table 55 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 56 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 57 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 58 Clinical Chemistry - Volume Price and Revenue Forecast
Table 59 Microbiology - Volume Price and Revenue Forecast
Table 60 Hematology - Volume Price and Revenue Forecast
Table 61 Anatomic Pathology - Volume Price and Revenue Forecast
Table 62 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 63 All Clinical Testing - Volume Price and Revenue Forecast
Table 64 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 65 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 66 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 67 Clinical Chemistry - Volume Price and Revenue Forecast
Table 68 Microbiology - Volume Price and Revenue Forecast
Table 69 Hematology - Volume Price and Revenue Forecast
Table 70 Anatomic Pathology - Volume Price and Revenue Forecast
Table 71 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 72 All Clinical Testing - Volume Price and Revenue Forecast
Table 73 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 74 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 75 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 76 Clinical Chemistry - Volume Price and Revenue Forecast
Table 77 Microbiology - Volume Price and Revenue Forecast
Table 78 Hematology - Volume Price and Revenue Forecast
Table 79 Anatomic Pathology - Volume Price and Revenue Forecast
Table 80 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 81 All Clinical Testing - Volume Price and Revenue Forecast
Table 82 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 83 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 84 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 85 Clinical Chemistry - Volume Price and Revenue Forecast
Table 86 Microbiology - Volume Price and Revenue Forecast
Table 87 Hematology - Volume Price and Revenue Forecast
Table 88 Anatomic Pathology - Volume Price and Revenue Forecast
Table 89 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 90 All Clinical Testing - Volume Price and Revenue Forecast
Table 91 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 92 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 93 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 184 Clinical Chemistry - Volume Price and Revenue Forecast
Table 185 Microbiology - Volume Price and Revenue Forecast
Table 186 Hematology - Volume Price and Revenue Forecast
Table 187 Anatomic Pathology - Volume Price and Revenue Forecast
Table 188 Molecular Diagnostics - Volume Price and Revenue Forecast
Table 189 All Clinical Testing - Volume Price and Revenue Forecast
Table 190 Cardiac Biomarkers - Volume Price and Revenue Forecast
Table 191 Molecular Diagnostic Oncology - Volume Price and Revenue Forecast
Table 192 Molecular Diagnostic Genetics - Volume Price and Revenue Forecast
Table 193 2015 Clinical Lab Fee Schedule

Table of Figures

Figure 1 Medicare Clinical Lab Expenditures 2004 to 2020 ($Million)

Companies Mentioned

- 14M Genomics
- 20/20 GeneSystems
- 23andMe
- 3M
- ACM Medical Laboratory
- ACT Genomics
- AITbiotech
- ARUP Laboratories, Inc.
- AbVitro
- Abbott Diagnostics
- Abcam
- Accelerate Diagnostics
- Acibadem Labmed Laboratory
- Adaptive Biotechnologies
- Adarza BioSystems
- Adicon Clinical Laboratories, Inc.
- Advanced Cell Diagnostics
- Aegis Sciences
- Aeris Capital
- Aetna
- Aetna Innovation Lab
- Agena Bioscience
- Agendia
- Alberta Investment Management
- Alere Inc
- Allegro Dx
- Alliance Global
- AltheaDx
- Amarantus BioScience
- American Liberty Petroleum
- American Pathology Partners, Inc.
- AmoyDx
- Amplidiag
- Arcus Ventures
- Argo Group US
- Ariosa Diagnostics
- Arno Therapeutics
- Ascend Clinical, LLC
- AstraZeneca
- Asuragen
- Atossa Genetics Inc.
- Aurora Diagnostics, LLC
- Australia's Commonwealth Scientific and Industrial
- AutoGenomics
- Avant Diagnostics
- B. Braun Medical Inc.
- BC Biomedical Laboratories
- BD Diagnostics
- BDC Capital
- BGI
- BGI Dx
- BP Lab
- Bao Hao Investment Management of Shanghai
- Bay City Capital
- Baylor College of Medicine
- Becton Dickinson
- Bill & Melinda Gates Foundation
- Bina Technologies
- Bio-Reference Laboratories, Inc.
- BioAgilytix Labs
- BioChain
- BioFire
- BioGenerator
- BioHelix
- BioMed Invest
- BioMérieux
- BioNano Genomics
- BioTheranostics
- BioVeda China Fund
- Biocartis
- Biocept
- Biofortuna
- Bioinn Molecular Diagnosis
- Biomnis
- Bioscience Genomics
- Bioscientia Institut fuer Medizinische Diagnostik
- Blackberry
- Blackstone
- Bloom Burton & Co.
- Blueprint Genetics
- Bode Technology
- Bristol-Myers Squibb
- Broad Institute
- Broe Group
- Bruker
- C2N Diagnostics
- CBLPath
- CD Venture
- CML HealthCare Inc.
- CTI Life Sciences Fund
- Cambridge Innovation Capital
- Cancer Diagnostics
- Cancer Genetics
- Canon US Life Sciences
- Caprion
- CardioDx
- CareDx
- Caris Life Sciences, Inc.
- Cartagenia
- Casdin Capital
- Castle Biosciences
- Catalyst Health Ventures
- CeGaT GmbH
- Celgene
- Cell Signaling Technology
- Cellmark Forensics
- Center for Human Genetics and Laboratory
- Centrex Clinical Laboratories, Inc.
- Cepheid
- Cerner Corporation
- Chembio
- Chione
- Cigna
- Cinven
- Clarient, Inc.
- Claritas Genomics
- Claymon Biomnis Laboratories Ltd.
- Cleveland Clinic Laboratories
- Clinical Genomics
- Clinical Reference Laboratory, Inc.
- Clongen Laboratories LLC
- CollabRx
- CombiMatrix
- CompanionDx Reference Lab
- CompuNet Clinical Laboratories, LLC
- Concentra
- Contextual Genomics
- Cornell University
- Courtagen Life Sciences
- Covance Inc.
- Curetis
- CvergenX
- Cypher Genomics, Inc.
- DL Reference Laboratory
- Decheng Capital
- Deerfield Management
- Definiens
- DiaCarta
- DiaTech Oncology
- Diagnostics
- Diagnovus
- Diagnósticos da América (DASA)
- Dignity Health
- DioGenix
- Domain Associates
- Emory Genetics Laboratory
- Empire Genomics
- Endeavour Vision
- Enlighten Health Genomics
- Enzo Biochem, Inc.
- Epic Sciences
- Epigenomics
- Epistem
- Exagen Diagnostics, Inc.
- Feist-Weiller Cancer Center
- Firefly BioWorks
- Fisher Scientific
- Focus Diagnostics
- Forbion Capital
- Foundation Medicine
- GE Capital's Healthcare Financial Services
- GenMark Diagnostics
- GenSignia IP
- GeneCentric Diagnostics
- GeneInsight
- GeneNews
- GenePeeks
- Genentech
- Genesys Capital
- Genetic Signatures
- Genetic Technologies
- Genewave
- Genia Technologies
- Genisphere
- GenoLogics
- Genoma
- Genomas
- GenomeDx Biosciences
- Genomed
- Genomic Health, Inc.
- Genomic Vision
- Gentris
- Genzyme Corporation
- Global Health Investment Fund
- Glyconics
- GmbH
- Good Start Genetics
- Google
- Great Basin Scientific
- Gribbles Pathology
- Grifols
- HBM Partners
- HTG Molecular Diagnostics
- HealthCare Royalty Partners
- Helomics
- Highmark
- Hologic
- Horizon Blue Cross Blue Shield
- Horizon Technology Finance
- Human Longevity
- IMDx
- Illumina
- InformedDNA
- Inivata
- Inostics'
- Integrated Diagnostics
- Integrated Regional Laboratories, Inc.
- Intel
- InterWest Partners
- Interleukin Genetics
- Interpace Diagnostics
- Intrinsic LifeSciences
- Invenshure
- Invitae
- Invivoscribe Technologies
- Invoke Capital
- Iquum
- Isis Innovations
- Johnson & Johnson Development Corporation
- KKR
- Kaiser Permanente
- Kingmed Diagnostics
- Kuwait Investment Authority
- LSP Health Economics Fund
- Laboratory Corporation of America
- Labotix Automation Inc.
- Labsco
- Leica Biosystems
- Life Letters
- Life Science Partners
- Life Technologies
- Lifecode Inc.
- Lifelabs Medical Laboratory Services
- Lineagen
- LipoScience
- Luminex
- MDxHealth SA
- MEDTOX Scientific, Inc.
- MIG Funds
- Matrix-Bio
- Mayo Clinic
- Mayo Ventures
- MdxHealth
- MedImmune
- Medicus Phillipines Inc.
- Merck Serono
- Meridian Bioscience
- Meritech Capital Partners
- Metabolon, Inc.
- Metamark
- Mid America Clinical Laboratories, LLC
- Miraca Holdings
- Mobidiag
- Moffitt Cancer Center
- MolecularMD
- Mount Sinai Services
- Multiplicom
- Myriad Genetics, Inc.
- N-of-One
- NRW Bank
- NanoString Technologies
- Nanopharmacia
- Nanosphere
- NantHealth
- Natera
- Natural Molecular Testing Corp.
- NeoGenomics
- New Enterprise Associates
- New Summit Biopharma
- Newtopia
- NextGxDx
- Novacyt
- Nuclea Biotechnologies
- Nucleix
- Oneome
- Ontario Emerging Technologies Fund
- OpGen
- OrbiMed
- Ortho Clinical Diagnostics
- Osage University Partners
- OvaGene Oncology
- Oxford Finance
- PAML
- PDI, Inc.
- Pacific Biosciences
- Pacific Edge Diagnostic USA
- Parabase Genomics
- Path Labs
- Pathology Inc.
- Pathwork Diagnostics
- Perceptive Advisors
- PerkinElmer
- Personal Genome Diagnostics
- Personalis
- Pfizer Venture Investments
- Polymedco
- Precipio Diagnostics
- Predictive Biosciences, Inc.
- Premaitha Health
- Pressure BioSciences
- PrimeraDx
- Pronota
- Prostate Management Diagnostics
- Protagen
- Proteocyte Diagnostics
- Proteome Sciences,
- Proteomics International Laboratories
- Provista Diagnostics
- Psychemedics Corp.
- Purdue University
- Qiagen
- QuantRx® Biomedical Corporation
- QuantuMDx Group
- Quest Diagnostics
- Quidel
- Quintiles
- Rand Capital
- RedPath Integrated Pathology
- Redmile Group
- RegenWell Holdings
- Research Organisation
- Response Genetics
- Roche Diagnostics
- Roche MDx
- Roche Venture Fund
- Rock Springs Capital
- Roka Bioscience
- Rosetta Genomics Inc.
- RusnanoMedInvest
- SCP Buffalo Incubator Innovate NY Fund
- SWK Funding
- SWK Holdings
- Sciencewerke
- Sequenom, Inc.
- Sequenta
- Sequoia Capital
- Sera Prognostics
- Sidra
- Siemens
- Signal Genetics LLC
- Silicon Valley Bank
- Solstas Lab Partners
- SolutionPoint International
- Sonic Healthcare Limited
- Sophia Genetics
- Source BioScience
- South Texas Reference Laboratories
- Spectra Spectra Laboratories, Inc.
- Stratos Genomics
- Stratose
- Swisscom
- Syncona Partners
- Sysmex Inostics
- T2 Biosystems
- The Alliance Global Group
- The Doctor's Laboratory (Sonic Healthcare U.K.)
- The Mayo Clinic
- The Personalized Medicine Initiative
- Thermo Fisher
- Thomas McNerney & Partners
- Transgenomic
- Trinity Biotech plc
- Trovagene
- Tute Genomics
- Umass Clinical Laboratory
- Unilabs SA
- UnitedHealthcare
- UpStart Life Sciences Capital
- Venrock
- Ventana Medical Systems
- Veracyte
- Veridex
- Verizon
- Vermillion
- ViaLogy
- Victorian Clinical Genetics Services
- Vira Cor-Ibt Laboratories
- Warburg
- Wellcome Trust Sanger Institute
- Wellington Management
- Xagenic
- Zaffre InvestmentsACM Medical Laboratory

For more information visit http://www.researchandmarkets.com/research/pmd597/clinical



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