Physician-based Point of Care Diagnostics: Products, Players and Outlook to 2017
NEW YORK, Jan. 14, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Physician-based Point of Care Diagnostics: Products, Players and Outlook to 2017
http://www.reportlinker.com/p01081137/Physician-based-Point-of-Care-Diagnostics-Products-Players-and-Outlook-to-2017 .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic
The market for Point-of-Care (POC) diagnostic products used in the physician's surgery was worth approximately US$1.7 billion in 2011 with sectors such as cholesterol testing and tumour markers making the best continued growth in the year. All sectors will see sustained growth over the medium term, with the total addressable market for products that can be potentially used in a physician's office forging ahead to be valued at over US$6.1 billion by 2017.
In the physician's office, POC diagnostics can play a key role in the diagnosis and ongoing monitoring of acute and chronic illnesses, the detection of some types of cancer, the monitoring of patients on anticoagulation drugs, and for general blood and urine testing. It can also play an important role in enabling preventative medicine, which is intended to help curb the increasing incidence of chronic conditions such as diabetes and cardiovascular disease through early detection and identifying patients with risk factors that mean they are likely to develop such conditions in the future.
The benefits for clinicians, patients and health payers are clear. Physician-based testing provides rapid POC diagnosis and faster medical intervention. Healthcare providers are looking for new ways of improving patient outcomes, which in turn reduces the need for more expensive patient care, medications and hospital stays, as well as reducing costs and managing a larger number of patients without increasing staffing levels or numbers of hospital beds.
Challenges remain...
This new January 2013 report delivers a complete analysis Table of Contents MARKET OVERVIEW ..1 EXECUTIVE SUMMARY ......1 INTRODUCTION ....2Physician's Office POC Testing ....2The Role of POC Testing in a Physician's Office ....3Regulatory and Reimbursement Environment ....4CLIA Waiver .4
CURRENT MARKET DYNAMICS ......6
Fig.1: POC Diagnostics in Relation to the IVD Market, 2011 .6Fig.2: Percentage of POC Diagnostics Market by Product, 2011 .7Regional Perspective ....7Fig.3: Professional POC Diagnostics Market by Region, 2011 .....8Physician's Office POC Testing Market .....8Addressable Markets for Physician's Office POC Testing, 2007-2011 (US$ million) .....10Fig.4: Addressable Markets for Physician's Office POC Testing, 2011 .....10Fig.5: Physician's Office POC Testing Market, 2011 ......11
GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES .12
POC Diagnostics and the Economy . 12The Burden of Chronic Disease and Preventative Medicine . 12Clinical Utility and Accuracy ..... 14POC Diagnostics as a Disruptive Technology ...... 14Emerging Technologies ..... 15Summary: Market Drivers, Restraints and Opportunities 16
COMPETITIVE LANDSCAPE ....17
Market Leaders for Physician's Office POC Testing Products ....17Select POC Diagnostics Companies' Sales, 2007-2011 (US$ million) ......17Merger and Acquisition Activity ..... 17Key POC Diagnostics Mergers and Acquisitions, 2008-2011 ....18
FUTURE MARKET PROSPECTS ......20
Addressable Markets for Physician's Office POC Testing, 2011-2017E (US$ million) ...21Growth in the Addressable Markets for Physician's Office POC Testing, 2008-2017E (%) .21Physician's Office POC Testing Market, 2011-2012E (US$ million) ...21Fig.6: Physician's Office POC Testing Market, 2012(E) .22
PHYSICIAN'S OFFICE POC PRODUCTS AND TECHNOLOGIES ..23
POC HBA1C TESTING .23
Fig.7: Diabetes Prevalence by Geographic Region, 2011-2030 .23
Diabetes Prevalence for the Top 10 Countries, 2011-2030 (million) 24
Diabetes Management and the Role of HbA1c Testing ...25
POC HbA1c Testing Market 27
Fig.8: Global POC HbA1c Testing Market, 2007-2017E (US$ million) ......27
POC HbA1c Products ....27
ApexBio's A1C Express ....27
Alere/Axis-Shield's Afinion HbA1c and NycoCard HbA1c Tests ...27
Bayer's A1CNow Products .....28
Bio-Rad's in2it A1C Analyser 28
DiaSys Diagnostic Systems' InnovaStar .....28
Ceragem Medisys' HbA1c Analysers ...29
EKF Diagnostics' Quo-Lab, Quo-Test and Biosen HbA1c Analysers ...29
Infopia's Easy/Clover A1c 29
Siemens' DCA Vantage Analyser .29
Tosoh Bioscience's G8 HPLC Analyzer .30
In Development ......30
POC CHOLESTEROL TESTING ...... 32
POC Cholesterol Testing Market Dynamics ..33
Fig.9: Global POC Cholesterol Testing Market, 2007-2017E (US$ million) ....34
Fig:10: POC Cholesterol Testing Market by End User, 2011 ......34
Available Products ......35
Alere's Cholestech LDX System .....35
Akers Biosciences' Tri-Cholesterol Check ..35
Chematics' Chemcard Cholesterol Test ......35
General Life Biotechnology's BeneCheck LipidEx ST ...35
Infopia's Lipid Pro . 36
Jant Pharmacal's LipidPlus Lipid Profile and Glucose Test System ...... 36
Miraculins' PreVu Point of Care Skin Sterol Test .... 36
Distribution Agreements .....37
Polymer Technology Systems' CardioChek PA 37
Roche's Accutrend Plus .... 38
Syntron Bioresearch's Venture Total Cholesterol Test 38
Products in Development 38
Roche and Panasonic Healthcare .....38
POC COAGULATION TESTING ...... 39
Fig.11: Global POC Coagulation Market, 2007-2017E (US$ million) ......40
The Impact of New-Generation Anticoagulants .. 40
Patient Self-Testing and Issues for Doctors .41
CoaguSense's CoaguSense PT/INR Monitoring System ..... 43
Alere's INRatio2 System ... 43
International Technidyne Corporation's ProTime Microcoagulation System 43
Roche's CoaguChek XS .... 43
Professional Use Products 44
Alere's Axis-Shield Products ... 44
Helena Laboratories' Cascade POC System ..... 44
Instrumentation Laboratory's GEM PCL Plus .. 45
Roche's CoaguChek Systems .. 45
CoaguChek XS Pro .45
CoaguChek XS Plus 45
CoaguChek XS .45
CoaguChek Link ......45
Products in Development 46
Bio-AMD's COAG . 46
Siemens/Universal Biosensors' POC Coagulation Tests ..... 46
POC CLINICAL CHEMISTRY AND HAEMATOLOGY PRODUCTS ...... 47
Handheld POC Analysers Suitable for Use by Physicians ...47
Abaxis' Piccolo xpress ...47
Abbott's i-STAT System .48
Alere/Axis-Shield's Afinion POC System ...49
Alere/Axis-Shield's NycoCard System 49
Benchtop Systems Suitable for Physician's Laboratories .. 50
Alfa Wassermann's ACE Clinical Chemistry Systems ...50
Arkray's SpotChem Systems ......50
SpotChem Test Strips ....51
Audit Diagnostics' Liqui-Stat System 51
DiaSys Diagnostic Systems' InnovaStar ....51
Horiba's ABX Pentra Clinical Chemistry Analysers 52
Ortho-Clinical Diagnostics' VITROS DT60 II Chemistry System .52
Qualigen's FastPack IP System ....52
Samsung's LABGEO Clinical Chemistry Analysers .52
Tosoh Bioscience's AIA Immunoassay Analysers ..52
POC Haematology and Haemoglobin Analysers 53
POC Haemoglobin Systems .....53
POC Analyser Accuracy ..53
ACON Laboratories' Mission Hb Hemoglobin Testing Systems .54
ApexBio's HemoSmart Haemoglobin Screening System ...54
Audit Diagnostics' Hb-Stat ..54
Ceragem Medisys' CERA-CHEK Hb Plus ....54
EKF Diagnostics' Products ....54
General Life Biotechnology's BeneCheck Hb Hemoglobin Test System 55
OrSense's Glasswing and NBM 200 Systems ..55
Quest Diagnostics' HemoCue Haemoglobin Systems .56
URIT Medical's URIT-12 Hemoglobin Meter ....57
POC C-REACTIVE PROTEIN DIAGNOSTICS ...... 58
Alere/Axis-Shield ..59
bioMérieux bioNexia CRP Test .59
LifeAssays' CRP .....59
Medix Biochemica's Actim CRP 59
Orion Diagnostica's QuikRead and QuikRead go Systems ....59
POC PHYSICIAN'S OFFICE INFECTIOUS DISEASE TESTS ...60
Fig.12: Market for POC Infectious Disease Tests used in a Physician's Office, 2007-2017E (US$ million) 61
POC Influenza Testing .61
Performance and Use of Rapid Influenza Tests in the US .. 62
CDC Recommendations 62
CDC: Influenza Prevalence and Test Accuracy ......63
POC Influenza Testing Market 63
Future Prospects .. 64
CLIA-Waived Flu Detection Products .. 64
Alere's Influenza Tests ..64
Becton Dickinson's BD Veritor System ......64
Quidel's Sofia Analyzer and Sofia Influenza A+B Fluorescent Immunoassays ....65
Quidel's QuickVue Influenza Tests .....65
SA Scientific's SAS FluAlert .65
Other POC Flu Detection Products ...... 65
bioMérieux' bioNexia Influenza A+B Tests ....66
IQuum's Liat Influenza A/B Assay and the Liat Analyzer ...66
Jant Pharmacal's Accutest Flu Test ....67
Medix Biochemica's Actim Influenza A&B ......67
Meridian Bioscience's TRU FLU ...67
Mizuho Medy's Quick Chaser Flu A,B .67
OraSure Technologies' OraSure QuickFlu Rapid Flu A+B Test ...67
Princeton BioMeditech's BioSign Flu A+B .....67
Response Biomedical's Influenza A+B Test ....68
Sekisui Diagnostics' OSOM Influenza A & B Test ...68
Products in Development 68
Chembio's DPP Influenza Tests ...68
Cepheid's GeneXpert ....69
Lucigen's Nucleic Acid-Based POC Test ....69
Respiratory Syncytial Virus ......69
Quidel's Sofia RSV Fluorescent Immunoassay .70
Quidel's QuickVue RSV 10 .71
Response Biomedical's RSV Test ....71
Other Respiratory Tests .....71
Ani Biotech's Biocard Chlamydia Pneumoniae IgM Test .....71
GenBio's ImmunoFLOW Mycoplasma IgM Test ..... 72
Group A Streptococcus Tests ....72
Currently-Available POC Strep A Tests ...73
Quidel's Sofia Strep A Fluorescent Immunoassay 73
H. pylori Tests .74
Currently-Available H. pylori Tests . 74
Exalenz Bioscience's BreathID System 75
Otsuka America Pharmaceutical's BreathTek UBT .75
Mononucleosis Tests ...76
Currently-Available POC Mono Tests .....76
Rotavirus and Adenoviral Enteritis Tests .....76
Ani Biotech's Biocard Tests ......76
Meridian Bioscience ImmunoCard STAT! Rotavirus ..... 77
Nicox/Rapid Pathogen Screening's AdenoPlus .... 77
Orion Diagnostica's Diarlex, Rotalex and Adenolex Tests . 77
Women's Heath Diagnostics .....77
Ani Biotech's Biocard Candida and Trichomonas Tests ...... 77
Gryphus Diagnostics' BVBLUE ...... 77
Quidel's QuickView Chlamydia Test ... 78
RunBio Biotech's Tests ...... 78
Savyon Diagnostics' SavvyCheck . 78
POC TUMOUR MARKER TESTING ...... 79
Prostate Specific Antigen Tests 80
Available Tests 81
Mediwatch's PSAwatch 81
OPKO Health's OPKO Diagnostics Platform ....82
Occult Blood Testing ...82
ACON Laboratories' Mission FOB Reagent Strips . 83
Aerscher Diagnostics' HemaPrompt .. 83
Alere's Tests .... 83
Beckman Coulter's Hemoccult Tests .. 83
Biomerica's EZ Detect 83
bioMérieux' bioNexia FOBplus ..... 84
Helena Laboratories' ColoCare ..... 84
Immunostics' Hema-Screen ... 84
Orion Diagnostica's QuikRead System and Orion Q-flow FOB ...... 84
Princeton BioMeditech's BioSign iFOBTest ..... 84
Quest Diagnostics' InSure Quik F I T ... 85
Quidel's QuickVue iFOB ... 85
Other Available FOB Tests ...... 86
Gastric Occult Blood Tests 86
CEA Testing .....87
Alpha Fetoprotein Testing .87
Bladder Cancer Testing ......87
Alere's Matritech NMP22 BladderChek Test .... 88
bioMérieux' bioNexia BTA ...... 88
Mediwatch's Bladderwatch BTA Test .. 88
Novel Products in Development .....88
Bioscience Ventures/ Serascience's POC Myeloma Test ..... 88
Guided Therapeutics' Non-Invasive Cancer Diagnostic Products 88
LuViva Advanced Cervical Scan .88
Oesophageal and Other Cancer Detection ......89
Infopia's Cancer Diagnosing Sensor ... 90
POC URINALYSIS TESTING .... 91
Key Urine Analysis Test Strips ..92
Product Highlights ......92
77 Elektronika's DocUReader 2 and DocuReader 2 Pro ......92
ACON Laboratories' Mission Products .93
Arkray's Products ..93
PocketChem UA ......93
AUTION ELEVEN ......93
DiaScreen 50 Urine Chemistry Analyser and DiaScreen Reagent Strips 93
Roche's Products ...93
Urisys 1100 Urine Analyser ..93
Chemstrip Criterion II Analyzer ..94
Chemstrips/Combur-Test Strips .94
Siemens' Products 94
Clinitek Status+ .....94
Clinitek Status Connect .94
Multistix10 SG Reagent Strips ....94
RAPIDComm Data Management and Connectivity Solution ....95
Microalbumin Testing .95
Axis-Shield's Afinion ACR Test 95
Biomerica's Fortel Microalbumin Screening-OTC Test 96
Orion Diagnostica's QuikRead U-ALB . 96
Quest Diagnostics' HemoCue Albumin 201 System .... 96
Sekisui Diagnostics' OSOM ImmunoDip Urinary Albumin Test ..... 96
Siemens' Clinitek Microalbumin Strips ..... 96
OTHER PRODUCTS ... 97
Liver Function Testing .97
Exalenz Bioscience's BreathID System ...... 97
BreathID Methacetin Breath Test ......98
Infopia's Pioneer POCT Liver Test Sensor .. 98
Thyroid Tests ..98
Jant Pharmacal's Accutest TSH .... 98
Screening Devices Canada's ThyroChek ... 98
Ani Biotech's Biocard Coeliac Tests .99
Rapid Pathogen Screening's InflammaDry ..99
Products in Development ...... 100
Akers Biosciences' BreathPulmo Health Check and Breath Asthma Check 100
POC Breath Asthma Check .100
EMERGING TECHNOLOGIES ...... 101
Ativa Medical's POC System ....101
Bio-AMD's MPR ...102
Biosensia's RapiPlex .102
Cepheid's GeneXpert 103
MagnaBioSciences' MICT On-Site System ..104
Molecular Vision .104
MycroLab 105
OPKO Health's OPKO Diagnostics Platform ......106
pes diagnosesysteme' respons IQ .106
Philips' Minicare .107
Radisens Diagnostics' POC Platform ...108
T2 Biosystems' T2Dx System ..108
T2Hemostasis Assay 109
Tyrian Diagnostics' DiagnostIQ ....110
MANUFACTURERS .111
COMPANY DIRECTORY ..111 SELECTED COMPANY PROFILES .117Piccolo xpress 117
Financial Performance ....118
Abaxis Operating Results, 2007-2012 (US$ million) . 118
Latest Results 118
Akers Biosciences ......119
Recent Key Events .... 119
Current Products 120
PIFA Heparin/PF4 and PIFA PLUSS Rapid Assays 120
Tri-Cholesterol Check ..120
Research and Development ..121
BreathPulmo Health Check ...... 121
POC Breath Asthma Check . 121
Current Alliances and Distribution Agreements ..121
PULSE Health . 121
Al Tadawi Medical Equip/PharmaNova Medical Equipment ..122
Fisher HealthCare .122
US Government Service Administration Schedule Contract ...122
Financial Performance ... 122
Akers Biosciences Operating Results, 2007-2011 (US$ thousands) ..... 123
Fig.15: Percentage of Akers' Revenue by Product Type, 2011 123
Alere .124
Recent Key Events .... 124
POC Cardiology Diagnostic Products ...... 125
Alere Heart Check System ..125
Cholestech LDX .....125
INRatio2 System ...125
Axis-Shield POC Products ..... 125
Afinion POC System .... 126
NycoCard 126
Coagulation Products ......127
POC Oncology Products ..127
POC Infectious Disease Tests .127
POC Mergers & Acquisitions . 128
Axis-Shield ....128
Medical Automation Systems' .128
Standard Diagnostics ..128
Assets from Unotech Diagnostics ....128
Mologic, Jinsung Meditech, Biolinker and Long Chain International Corp ..128
Zycare, Medim and Biosyn .129
ACON Laboratories' Rapid Diagnostics Assets .... 129
Matria Healthcare 129
BBI Holdings .129
Other Acquisitions 129
Agreements .130
EKF Diagnostics ....130
Spartan Bioscience ......130
Financial Performance ....131
Alere - Operating Results, 2007-2011 (US$ million) . 132
Fig.16: Percentage of Alere's Revenue by Segment, 2011 ...... 132
Fig.17: Percentage of Alere's Revenue by Region, 2011 .. 132
Alere Professional Diagnostics: Operating Results, 2007-2011 (US$ million) ... 133
Alere Professional Diagnostics: Net Sales & Services Revenue, 2007-2011 (US$ million) ...... 133
Fig.18: Alere Professional Diagnostics: Net Sales & Services Revenue by Product, 2011 . 133
Latest Results ...... 133
Axis Shield - Financial Performance 134
Fig.19: Axis-Shield Revenue by Business Unit, 2010 . 135
Fig.20: Axis-Shield Revenue by Region, 2010 .... 135
Axis-Shield - POC Segment Operating Results, 2006-2010 (£ million) ...... 135
Axis-Shield - POC Sales by Product Line, 2006-2010 (£ million) .. 136
Fig.21: Axis-Shield POC Sales by Product, 2010 . 136
Fig.22: Axis-Shield Afinion Sales by Region, 2010 .... 136
Arkray .....137
Recent Key Events .... 137
POC Testing Products .....137
SpotChem EZ Dry Chemistry Analyser .. 137
SpotChem D-Concept .138
SpotChem CL SB-1440 Automatic Blood Cell Counter ......138
PocketChem BA Blood Ammonia Meters .....138
Urinalysis 139
Current Alliances 139
ELITech Group 139
Beckman Coulter (Danaher) ...140
POC Products ...... 140
Hemoccult Tests ..140
Gastroccult .... 141
International Technidyne Corporation ......142
Products . 142
ProTime Coagulation Systems .. 142
Hemochron Whole Blood Coagulation System .. 142
Current Alliances 143
Roche ...... 143
Financial Performance ... 143
International Technidyne Operating Results, 2004-2009 (US$ million) ....144
Fig.23: International Technidyne Revenue, 2000-2010 (US$ million) 144
Orion Diagnostica ......145
QuikRead 101 System ..... 145
QuikRead go 145
Uricult Dipslide Tests ...... 146
Rotaviral and Adenoviral Enteritis Tests . 146
Financial Performance ....147
Orion Diagnostica - Operating Results, 2007-2011 (EUR million) 147
Meridian Bioscience ..148
TRU FLU and TRU RSV ..... 148
ImmunoCard STAT! HpSA H. pylori Test .. 148
ImmunoCard STAT! Rotavirus ..... 148
ImmunoCard STAT! Strep A .. 148
ImmunoCard STAT! MONO ... 148
ImmunoCard STAT! hCG Combo Test 149
Financial Performance ... 149
Meridian Bioscience - Operating Results, 2008-2012 (US$ million) ....149
Meridian Bioscience - Third-Party Sales by Segment, 2008-2012 (US$ million) .....149
Meridian Bioscience - Operating Income by Segment, 2008-2012 (US$ million) ....149
Fig.24: Meridian Bioscience - Revenue by Segment, 2012 ....150
Meridian Bioscience - European Diagnostics Sales by Country, 2006-2011 (US$ million) .....150
Outlook ...150
Quest Diagnostics ......151
HemoCue Products ...151
Haemoglobin Systems 151
HemoCue Albumin 201 System .... .. . 152
HemoCue White Blood Cell Analyzer ..... 152
HemoCue WBC DIFF .... 153
HemoCue Basic Data Management and Connectivity Software ... 153
Enterix Products . 153
InSure Quik F I T Fecal Immunochemical Test ... .. 153
Litigation with EKF Diagnostics .. 154
Financial Performance ... 154
Quest Diagnostics - Operating Results, 2007-2011 (US$ million) 155
Quest Diagnostics - Sales and Earnings by Category, 2007-2011 (US$ million) ...... 155
Fig.25: Quest Diagnostics - Revenue by Division, 2011 .. 155
Latest Results and Outlook 155
Quidel ....157
Recent Key Events .... 157
Sofia Analyzer and the Sofia Influenza A+B Fluorescent Immunoassay 157
QuickVue Rapid Tests ..... 158
QuickVue Influenza Tests ...158
QuickVue Group A Strep Tests ...158
QuickVue RSV Tests .....158
QuickVue+ Infectious Mononucleosis ... 159
QuickVue iFOB ..... 159
QuickVue H. Pylori gII Test . 159
Financial Performance ... 159
Quidel - Operating Results, 2007-2011 (US$ million) .....160
Quidel - Revenue by Product Type, 2008-2011 (US$ million) 160
Fig.26: Quidel - Revenue by Product Type, 2011 ......160
Fig.27: Quidel - Infectious Disease Revenue, 2005-2011 (US$ million) ...... 161
Quidel - Revenue by Region, 2005-2011 (US$ million) .. 161
Fig.28: Quidel - Revenue by Region, 2011 .. 161
Latest Results ...... 162
Roche Diagnostics .....163
Recent Key Events ....163
CoaguChek Systems 164
CoaguChek XS Pro ......164
CoaguChek XS Plus .....164
CoaguChek XS ......164
CoaguChek Link ....164
Urinalysis 165
Urisys 1100 Urine Analyser 165
Chemstrip Criterion II Analyzer 165
Chemstrips/Combur-Test Strips ......165
Current Alliances and Contracts . 165
Panasonic Healthcare .165
Voluntis ...166
Financial Performance ... 166
Roche Diagnostics Operating Results, 2010-2011 (SFr million) ...166
Fig.29: Roche Diagnostics - Revenue by Product Line, 2011 .167
Fig.30: Roche Professional Diagnostics - Revenue by Region, 2011 ....167
Latest Results 167
Sekisui Diagnostics ...168
Point of Care Tests .... 168
OSOM RSV/Adenovirus Rapid Test ..168
OSOM Influenza A & B Test 168
OSOM H. pylori ....168
OSOM Ultra Strep A .....168
OSOM Strep A 169
OSOM Mono ..169
OSOM Trichomonas Rapid Test .169
OSOM BVBLUE Test ......169
OSOM ImmunoDip Urinary Albumin Test .....169
OSOM Pregnancy Tests ......169
Siemens Healthcare ..170
Products ..170
Diabetes Testing - DCA Vantage Analyser ..... 170
Urinlysis Products 171
RAPIDComm Data Management and Connectivity Solution .. 172
Current Alliances and Supply Contracts .. 172
Universal Biosensors ...172
Premier ...173
Roche ......173
Financial Performance ... 173
Latest Results 173
Thermo Fisher Scientific ..174
Sure-Vue Tests ......174
Remel's Xpect Tests ...174
APPENDICES ...175
APPENDIX 1 - LIST OF ABBREVIATIONS . 175 APPENDIX 2 - REPORT METHODOLOGY 176Market forecasts .177
SELECTED COMPANY PROFILES
• Akers Biosciences
• Alere
• Arkray
• Beckman Coulter (Danaher)
• International Technidyne Corporation
• Orion Diagnostica
• Meridian Bioscience
• Quest Diagnostics
• Quidel
• Roche Diagnostics
• Sekisui Diagnostics
• Siemens Healthcare
• Thermo Fisher Scientific
To order this report:In_Vitro_Diagnostic Industry: Physician-based Point of Care Diagnostics: Products, Players and Outlook to 2017
Nicolas Bombourg
Reportlinker
Email: [email protected]
US: (805)652-2626
Intl: +1 805-652-2626
SOURCE Reportlinker
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