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The Worldwide Market for Cancer Diagnostics, 4th Edition

$4,200.00 – $8,400.00

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SKU: KLI2504623 Categories: Diagnostics Market Research, Oncology & Hematology Market Reports Pages: 450
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Description

Since Kalorama Information last updated our comprehensive market report on cancer testing, changes in the industry abound. Developments that were novel two years ago such as the commercialization of service products , PGx testing and tissue microarrays are showing an increased presence. Some companies who promised much in the past have not produced results. And new entrants have entered the field.

These changes and more are addressed in Kalorama Information’s Worldwide Market for Cancer Diagnostics, 4th. Edition. This report authored by Kalorama Diagnostic Analyst Shara Rosen, contains detailed market data on the following IVD segments for their use in cancer diagnostics:

 

  • Histology/Cytology
  • Immunoassays
  • Flow Cytometry
  • Rapid Tests
  • Molecular Assays
  • Tissue Arrays
  • Circulating Tumor Cells
  • Pharmacodiagnostics

 

 

Cancer Testing: A Dynamic Field
Given the unfortunate statistics of cancer in the developed world, innovation is a must. Growth rates in cancer testing tends to be higher than in other IVD fields. Diagnostic tests for effective cancer screening are obviously needed more than ever. As cancer becomes more treatable, diagnostics are finding multiple expanded roles, including pharmacodiagnostics for matching the targeted treatment to the patient and ongoing disease monitoring as treatable cancer enters the realm of the chronic disease. Often these tests are commercialized as test services, a trend explored in the report.

Cogent Analysis of Trends in the Industry
Kalorama Information reports are always based on primary research of the market with particular attention to important market trends that are more important to understand than today’s numbers. Shara Rosen not only defines the marketplace and provides market numbers, but her report also examines trends that are driving cancer testing now and determining where it will go in the future. Some of the trends examined in this report include:

 

  • Biomarkers and Their Use in Cancer Testing
  • The Promise, and Reality of Personalized Medicine
  • Miniaturization and Multiplexed Biological Assays
  • The Emergence of Non-invasive tools
  • The Use of New Platforms:

 

    • Mass Spectrometry Chromosome Analysis,

 

    • Next-Generation Sequencing and RNA-based Tests

 

  • The In Vitro/In Vivo Mix
  • Global Screening Efforts and Their Impact on Testing Sales
  • Mergers and Partnerships in 2008 and 2009
  • Reimbursement for Cancer Tests

 

Based on an analysis of these trends, the report includes a ‘Technology Forecast’ to 2025 that takes each particular technology used now in solid tumor testing and predicts its future role.

Helpful Data Points for Business Planning
Kalorama Information’s Worldwide Market for Cancer Diagnostics, 4th Edition represents the fourth time Kalorama has engaged in an exhaustive study on the status of this important diagnostic market. The report contains scores of tables with data points that can be useful for marketing strategy, product development or business forecasting. Here are a sampling of the data points readers could find in this report:

  • Sales of Immunoassay Lab-Based Tests (PSA, CEA, CA 125, AFP, Others) in 2009
  • The Number of Pap Smear Tests Conducted in the US.
  • World Incidence and Prevalence of Cancer Statistics
  • Point of Care Tests for Cancer
  • DNA Reagents for Cancer Testing
  • The Projections and Actual Results of CTC Test Products
  • The Needs of the Marketplace Not Met by Any Vendor
  • Innovative Biochip Products
  • A List of “Laggard” Companies Who Have Not Met Expectations
  • The Major Protein and Molecular Markers Used in Tissue Staining
  • Biomarkers Currently Under Investigation
  • Microarray Markets in Clinical Labs
  • Lists of Vendors and Major Products

 

Dualistic Market Analysis
This latest edition of Kalorama Information’s study takes a fresh look at all of these developments both qualitatively and quantitatively. The report provides revenue and growth forecasts through 2014 and, as in the previous edition, analyzes the market in two ways:

 

  • Tests for specific cancers,

 

    • and

 

  • Cancer tests in specific IVD segments

 

This allows the reader to match his or her own situation to the market at large.

Unparalleled Review of Competitors: Top Tier IVDs, Status Quos and Novel Entrants
In addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles in three sections. The activities of the top IVD companies in cancer testing are presented in full, as are the activites of those ‘status quo’ companies who are leading in at least one segment. There is also coverage of the possible leaders of the future, the novel companies who have entered the market or developed a new approach. Companies profiled include the following:

Top Tier Companies

  • Abbott Diagnostics
  • Beckman Coulter Inc.
  • Becton, Dickinson and Company (BD)
  • bioMerieux Inc.
  • Bio-Rad Laboratories Inc.
  • Dako A/S
  • Fujirebio Diagnostics, Inc.
  • Gen-Probe Inc.
  • Hologic, Inc.
  • Inverness Medical Innovations
  • Ortho Clinical Diagnostics
  • QIAGEN N.V.
  • Roche Diagnostics
  • Siemens Medical Solutions Diagnostics
  • Sysmex Corporation 
    Status Quo Leader Companies
    • AdnaGen AG
    • Agendia BV
    • AMDL Diagnostics, Inc. (ADI)
    • American Diagnostica Inc.
    • Aperio Technologies, Inc.
    • Asuragen, Inc.
    • AviaraDx
    • Binding Site (The) Ltd.
    • BioCurex Inc.
    • BioGenex Laboratories, Inc.
    • BioImagene
    • Bio-Reference Laboratories, Inc.
    • Biotage AB
    • bioTheranostics
    • BioView Ltd.
    • Celera Diagnostics
    • China Medical Technologies, Inc.
    • Cisbio Bioassays
    • Clarient Inc. (formerly ChromaVision)
    • Clinical Data, Inc.
    • CytoCore, Inc.
    • DxS Ltd.
    • Epigenomics AG
    • Genetix Applied Imaging
    • Genomic Health, Inc.
    • Genzyme Genetics
    • Health Discovery Corporation
    • HistoRx, Inc.
    • Ikonisys, Inc.
    • Ipsogen SA
    • Lab21 Healthcare
    • Laboratory Corporation of America Holdings (LabCorp)
    • Life Technologies
    • Monogram Biosciences, Inc.
    • mtm laboratories AG
    • Myriad Genetics, Inc.
    • Nanosphere, Inc.
    • OncoVista Innovative Therapies, Inc.
    • Pathwork Diagnostics
    • Precision Therapeutics
    • Prometheus Laboratories Inc.
    • Quest Diagnostics
    • Response Genetics, Inc.
    • Rosetta Genomics Ltd.
    • Sequenom
    • Transgenomic Inc.
    • Veridex, LLC
    • Vermillion Inc.
    • Zila, Inc.


    New Entrants

    • 20/20 GeneSystems, Inc.
    • 454 Life Sciences Corporation
    • Acrometrix Corporation (Life Tech.)
    • Acupath Laboratories, Inc.
    • Advalytix
    • Affymetrix, Inc.
    • Allegro Diagnostics
    • Althea Technologies, Inc.
    • Amorfix Life Sciences Ltd.
    • Arbor Vita Corporation
    • ArcticDx Inc.
    • Arrayit Diagnostics Inc.
    • AVEO Pharmaceuticals, Inc.
    • Axela, Inc.
    • Baypoint Biosystems, Inc.
    • Biodesix, Inc.
    • Biologix Diagnostics, LLC
    • BioMarker Strategies, LLC
    • Biomoda
    • BioMosaics
    • BioProspecting NB, Inc. (BPNBI)
    • BioServe
    • Biosystems International SAS (BSI)
    • BioTrove, Inc.
    • Cambridge Research & Instrumentation, Inc. (CRi)
    • Cangen Biotechnologies, Inc.
    • Caris Diagnostics
    • Castle Biosciences Inc.
    • Celerus Diagnostics
    • Cell Biosciences
    • CeMines, Inc.
    • Cepheid
    • ChromoCure Inc.
    • Chronix Biomedical Inc.
    • Clinical Genomics Pty Ltd.
    • CombiMatrix Molecular Diagnostics (CMDX)
    • Comprehensive Cancer Cell (CCC) Diagnostics Inc.
    • Compugen Ltd.
    • Correlogic Systems, Inc.
    • CS-Keys, Inc.
    • deCode Genetics Inc.
    • DiaGenic ASA
    • DiagnoCure —
    • Diagnoplex
    • Diagnostic Biosystems Company
    • DNA Direct, Inc.
    • DexTerity Diagnostics
    • EDP Biotech Corporation
    • Epistem Plc
    • Exact Sciences Corp.
    • Exiqon A/S
    • ExonHit Therapeutics
    • Exosome Diagnostics Inc.
    • Expression Pathology Inc.
    • Falcon Genomics, Inc.
    • FASgen Diagnostics, LLC
    • Fluxion Biosciences
    • Foligo Therapeutics, Inc.
    • Gastrocor
    • Genelex Corporation
    • GeneNews Limited
    • Genoptix
    • iKaryos Diagnostics
    • Illumina
    • Inostics GmbH
    • InteRNA Technologies B.V.
    • Intrinsic Bioprobes Inc.
    • Invirion Diagnostics, LLC
    • InVivoScribe Technologies
    • Iris BioTechnologies Inc.
    • IRIS International, Inc.
    • MabCure Inc.
    • MacroArray Technologies, LLC
    • MagArray Inc.
    • Martell Biosystems, Inc.
    • Med BioGene, Inc. (MBI)
    • Medical Prognosis Institute
    • Metabolon, Inc.
    • Miraculins Inc.
    • MolecularMD Corp.
    • Neogenix Oncology, Inc.
    • NextGen Sciences
    • Nuvera Biosciences
    • Olink AB
    • Oncimmune LLC
    • OncoMethylome Sciences S.A.
    • On-Q-ity
    • Orion Genomics
    • Oxford BioTherapeutics
    • Pacific Edge Biotechnology Ltd. (PEB)
    • Photocure ASA
    • Power3 Medical Products, Inc.
    • Prediction Sciences
    • Predictive Biosciences
    • PrognosDx Health, Inc.
    • Provista Life Sciences LLC
    • Rubicon Genomics, Inc.
    • Rules-Based Medicine, Inc. (RBM)
    • Saladax Biomedical, Inc. (SBI)
    • SensiGen LLC
    • Sienna Cancer Diagnostics
    • Signature Genomic Laboratories, LLC
    • Singulex Inc.
    • Skyline Diagnostics B.V.
    • Source MDx
    • Soar BioDynamics, Ltd.
    • Strategic Diagnostics Inc.
    • Synergenz Bioscience Ltd.
    • Targeted Molecular Diagnostics (TMD)
    • Theranostics Health (TH)
    • TrimGen Corporation
    • TrovaGene, Inc.
    • Vitatex Inc.
    • WaferGen Biosystems, Inc.
    • Xceed Molecular (formerly MetriGenix Corporation)
    • Zetiq Technologies Ltd.

    All market data is based on factory sales to the end user and not retail pricing or reimbursement payments. For cancer testing, this means that the actual dollar market – that is what manufacturers earn from the sale of their products is undervalued. Market data is presented in dollar market size for categories of tests, and for specific analytes where possible.

    The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and imaging techniques presented in the report are expected to replace the standard of care in 2010, but with healthcare systems’ emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.

    The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author’s industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics, imaging industries and cancer specialists.

Table of Contents

CHAPTER ONE: Executive Summary

Introduction

Scope and Methodology

Size and Growth of the Market

Test Segments

Geographic Distribution

Market Trends

Death Rates

Revolutionary Therapeutics

Physician Factor

Consumer Lobby

Price

CHAPTER TWO: Introduction

Background

Pharmacogenomics

Test Service Commercialization

Cancer – Diagnosis and Therapy Management

Point of View

CHAPTER THREE: Market Trends In The Commercialization Of Cancer Diagnostics

Background

Demographics of Cancer, a Global Phenomenon

Cancer Testing in the World:

Screening and Government Supported Programs

United States of America

International

Europe

Mexico

China

India

Reimbursement and Commercialization of Novel Tests

Test Services – Route for Cancer Innovation

Table 3-3

Regulatory requirements of new products

Strategic Alliances and Partnerships

Personalized Medicine Advances

Gene Patents and Test Commercialization

CHAPTER FOUR: Technological Trends

Background

Biomarker Revolution

The promise of Personalized Medicine

Miniaturization and Multiplexed Biological Assays

The emergence of non-invasive tools

New Technologies Applied To Cancer Diagnostics

Overview

New Platforms

Mass Spectrometry

Chromosome Analysis

Next-Generation Sequencing

RNA – Ribonucleic Acid

The In Vitro/In Vivo Mix

CHAPTER FIVE: Market Analysis

Background

World Regional Segments of the Market for Cancer Diagnostics

Companies and Products

Has Screening Lost its Allure?

Cancer Specific Tests

Bladder Cancer

Breast Cancer

Cervical Cancer

Colon Cancer

Lung Cancer

Ovarian Cancer

Prostate Cancer

CHAPTER SIX: Cancer Tests in IVD Segments (Segment Analysis)

Cancer Diagnostics and IVD Markets

The Market For Cancer Tests In Clinical Chemistry

The Market For Immunoassay Cancer Tests, Lab & Rapid

Point-of-care

The Market for Cancer Tests in Histology / Cytology

Traditional Tissue Stains

Pap Smear and HPV Testing

IHC/ISH

The Market for Tissue Microarrays

The Market For Cancer Tests in Flow Cytometry

The Market for Circulating Tumor Cells in Cancer Diagnostics

The Market For Cancer Molecular Assays

The Market For Cancer Tests in Pharmacodiagnostics

The market for Biochips and Arrays in Cancer Diagnostics

The Commercial Outlook for Cancer Diagnostics

CHAPTER SEVEN: Conclusions

Conclusions and Strategic Implications

Conclusion 1

Implication:

Conclusion 2

Implication:

Conclusion 4

Implication

Conclusion 5

Implication:

Conclusion 6:

Unmet Market Needs

Unmet Need #1

Unmet Need #2

Unmet Need #3

CHAPTER EIGHT: The Top Tier of IVD Companies and their investment in cancer diagnostics

Abbott Diagnostics

Molecular Histology

Molecular Diagnostics

Immunoassays

Beckman Coulter Inc

FOB

Flow Cytometry

Becton, Dickinson and Company (BD)

Histology

bioMerieux Inc

Bio-Rad Laboratories Inc

Dako A/S

Fujirebio Diagnostics, Inc

Gen-Probe Inc

Hologic, Inc

Histology

HPV

Inverness Medical Innovations

Ortho Clinical Diagnostics

QIAGEN N.V

Roche Diagnostics Indianapolis, IN www.roche.com Recent Revenue History ($ million)

Histology

Immunoassays

PCR

Research

Siemens Medical Solutions Diagnostics

Molecular

In Vivo

Sysmex Corporation

CHAPTER NINE: The Status Quo in Cancer Diagnostics

AdnaGen AG

Agendia BV

AMDL Diagnostics, Inc. (ADI)

American Diagnostica Inc

Aperio Technologies, Inc

Asuragen, Inc

AviaraDx

Binding Site (The) Ltd

BioCurex Inc

BioGenex Laboratories, Inc

BioImagene

Bio-Reference Laboratories, Inc

Biotage AB

bioTheranostics

BioView Ltd

Celera Diagnostics

China Medical Technologies, Inc

Cisbio Bioassays

Clarient Inc. (formerly ChromaVision)

Clinical Data, Inc

CytoCore, Inc

DxS Ltd

Epigenomics AG

Genetix Applied Imaging

Genomic Health, Inc

Genzyme Genetics

Health Discovery Corporation

HistoRx, Inc

Ikonisys, Inc

InterGenetics Inc

Ipsogen SA

Lab21 Healthcare

Laboratory Corporation of America Holdings (LabCorp)

Life Technologies

Monogram Biosciences, Inc

mtm laboratories AG

Myriad Genetics, Inc

Nanosphere, Inc

OncoVista Innovative Therapies, Inc

Pathwork Diagnostics

Precision Therapeutics

Prometheus Laboratories Inc

Quest Diagnostics

Response Genetics, Inc

Rosetta Genomics Ltd

Sequenom

Transgenomic Inc

Veridex, LLC

Vermillion Inc

Zila, Inc

CHAPTER TEN: New Entrants And Novel Product Developers

20/20 GeneSystems, Inc

454 Life Sciences Corporation

Acrometrix Corporation (Life Tech.)

Acupath Laboratories, Inc

Advalytix

Affymetrix, Inc

Allegro Diagnostics

Althea Technologies, Inc

Amorfix Life Sciences Ltd

Arbor Vita Corporation

ArcticDx Inc

Arrayit Diagnostics Inc

AVEO Pharmaceuticals, Inc

Axela, Inc

Baypoint Biosystems, Inc

Biodesix, Inc

Biologix Diagnostics, LLC

BioMarker Strategies, LLC

Biomoda

BioMosaics

BioProspecting NB, Inc. (BPNBI)

BioServe

Biosystems International SAS (BSI)

BioTrove, Inc

Cambridge Research & Instrumentation, Inc. (CRi)

Cangen Biotechnologies, Inc

Caris Diagnostics

Castle Biosciences Inc

Celerus Diagnostics

Cell Biosciences

CeMines, Inc

Cepheid

ChromoCure Inc

Chronix Biomedical Inc

Clinical Genomics Pty Ltd

CombiMatrix Molecular Diagnostics (CMDX)

Comprehensive Cancer Cell (CCC) Diagnostics Inc

Compugen Ltd

Correlogic Systems, Inc

CS-Keys, Inc

deCode Genetics Inc. —

DiaGenic ASA

DiagnoCure —

Diagnoplex

Diagnostic Biosystems Company

DNA Direct, Inc

DexTerity Diagnostics

EDP Biotech Corporation

Epistem Plc

Exact Sciences Corp

Exiqon A/S

ExonHit Therapeutics

Exosome Diagnostics Inc

Expression Pathology Inc

Falcon Genomics, Inc

FASgen Diagnostics, LLC

Fluxion Biosciences

Foligo Therapeutics, Inc

Gastrocor

Genelex Corporation

GeneNews Limited

Genoptix

iKaryos Diagnostics

Illumina

Inostics GmbH

InteRNA Technologies B.V

Intrinsic Bioprobes Inc

Invirion Diagnostics, LLC

InVivoScribe Technologies

Iris BioTechnologies Inc

IRIS International, Inc

MabCure Inc

MacroArray Technologies, LLC

MagArray Inc

Martell Biosystems, Inc

Med BioGene, Inc. (MBI)

Medical Prognosis Institute

Metabolon, Inc

Miraculins Inc

MolecularMD Corp

Neogenix Oncology, Inc

NextGen Sciences

Nuvera Biosciences

Olink AB

Oncimmune LLC

OncoMethylome Sciences S.A

On-Q-ity

Orion Genomics

Oxford BioTherapeutics

Pacific Edge Biotechnology Ltd. (PEB)

Photocure ASA

Power3 Medical Products, Inc

Prediction Sciences

Predictive Biosciences

PrognosDx Health, Inc

Provista Life Sciences LLC

Rubicon Genomics, Inc

Rules-Based Medicine, Inc. (RBM)

Saladax Biomedical, Inc. (SBI)

SensiGen LLC

Sienna Cancer Diagnostics

Signature Genomic Laboratories, LLC

Singulex Inc

Skyline Diagnostics B.V

Source MDx

Soar BioDynamics, Ltd

Strategic Diagnostics Inc

Synergenz Bioscience Ltd

Targeted Molecular Diagnostics (TMD)

Theranostics Health (TH)

TrimGen Corporation

TrovaGene, Inc

Vitatex Inc

WaferGen Biosystems, Inc

Xceed Molecular (formerly MetriGenix Corporation)

Zetiq Technologies Ltd

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

CHAPTER THREE: MARKET TRENDS

Table 3-1: Participation rates of CRC screening in National Programs and Pilot Studies

Table 3-2: Selected Lab Service Cancer Tests Launched in 2008 & 2009

Table 3-3: Selected CLIA-certified labs established in 2008 & 2009

Table 3-4: Selected acquisitions and mergers, 2008-2009

Table 3-5: Selected Company Alignments for Cancer Diagnostics, 2008-2009

Table 3-6: Selected collaborations Between IVD and Pharmaceutical Companies, 2008-2009

Table 3-7: U.S. Patents for Selected Molecular Test Platforms

CHAPTER FOUR: TECHNOLOGY TRENDS

Table 4-1: Selected Novel Biomarkers Under Investigation

Table 4-2: Selected biochip test and service innovations, 2008-2009

Table 4-3: Selected Innovations in Blood-Based Cancer Diagnostics, 2008-2009

Table 4-4: Selected non-invasive cancer test innovations, 2008-2009

Table 4-5: Selected test platform innovations, 2008-2009

Table 4-6: Selected companies involved in chromosomal analysis of cancer cells

CHAPTER FIVE: MARKET ANALYSIS

Table 5-1: World Cancer Statistics, new cases per year

Table 5-2: World Population, Cancer Patients and Percentage of Cancer Market IVD Statistics, 2005

Table 5-3: World Cancer Test Sales, by Region, 2009-2014

Table 5-4: Revenues of Selected Cancer Testing Companies($MM)

Table 5-5: Selected Underperformers in the Cancer Market, 2008-2009

Table 5-6: Cancer Diagnostics and the Top Tier of IVD Companies

Table 5-7: Selected new histological breast cancer tests, 2008-2009

Table 5-8: Selected Breast Cancer Test Innovations, 2008-2009

Table 5-9: Selected HPV test innovations, 2008-2009

Table 5-10: Selected colon cancer test innovations, 2008-2009

Table 5-11: Selected PGx tests for colon cancer, 2008-2009

Table 5-12: Selected Lung Cancer Innovations, 2008-2009

Table 5-13: Selected Ovarian Cancer Test Innovations, 2008-2009

Table 5-14: Selected Prostate Cancer Test Innovations, 2008-2009

CHAPTER SIX: SEGMENT MARKET ANALYSIS

Table 6-1: Worldwide Market for Selected Cancer In Vitro Diagnostics (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, Tissue Arrays, CTCs, Pharmacodiagnostics) 2009-2014

Table 6-2: Selected Tissue Function Clinical Chemistry Tests

Table 6-3: Major Players For Clinical Chemistry Analyzers And Reagents

Table 6-4: Selected Innovations in Cancer Immunoassays, 2008-2009

Table 6-5: Cancer Immunoassay Sales, Lab-based, (PSA, CEA, CA 125, AFP, Others), 2009-2014

Table 6-6: Rapid Cancer Test Sales by Test Category (Fecal Occult Blood, PSA H Pylori, NMP22, Other), Worldwide 2009-2014

Table 6-7: Worldwide Histology/Cytology Sales (Traditional Non Pap, Pap, IHC, ISH, Image Cytometry, Tissue Micorarrays) 2009-2014

Table 6-8: Selected Vendors of Traditional Histology Stains

Table 6-9: Selected HPV Tests Innovations, 2008-2009

Table 6-10: Major Protein and Molecular Markers Used in Tissue Staining

Table 6-11: Selected Chromosome-Based Cancer Tests, 2008-2009

Table 6-12: Selected Digital Imaging Innovations, 2008-2009

Table 6-13: Selected Histopathology Innovations, 2008-2009

Table 6-14: Selected Tissue Microarray Products, 2008-2009

Table 6-15: Selected molecular Cancer Test Innovations, 2008-2009

Table 6-16: Selected Cancer PGx Test Innovations, 2008-2009

Table 6-17: Selected Array-Based Cancer Test Innovations, 2008-2009

Table 6-18: Technology Penetration Forecast for Cancer IVDs 2005-2025 (Minor Role, Moderate Role, Major Role, Rarely Used)

 

    Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 12th Edition
    May 13, 2025
    In Vitro Diagnostic (IVD) Trends and Market Update, 2025
    April 7, 2025
    In Vitro Diagnostics Business Outlook, 2025 (6 Issues)
    April 3, 2025
    Molecular Diagnostics Quarterly Datastream, 2025
    April 2, 2025

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