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Diagnostic Test Service Commercialization in Multiplex and Esoteric Testing: A Roadmap to Diagnostics in the 21st Century

Test services, once the norm in the diagnostics industry, then abandoned for reagent sales, are now making a comeback.

IVD companies have established cGMP and CLIA-registered labs by which they offer their proprietary tests to physicians, hospitals and reference labs. These tests are outside the oversight of the traditional FDA and CE Mark test commercialization avenue in the U.S, and Europe and so are thought to come to market by what may seem to be the back door.

Kalorama has been watching this trend, and in her unique report, Kalorama Information's diagnostic analyst Shara Rosen covers the increasing trend in diagnostics towards servicing of tests in addition to selling test kit products and where this fits into the IVD industry today.

Information in this report includes

  • Current market and forecast for diagnostics test services
  • Detailed Analysis of the Esoteric Test Market (Clinical Chemistry, Immunoassays, Radioimmunoassays, Coagulation, Histology/Cytology, Nucleic Acid Assays, Flow Cytometry)
  • Review of Current Products on the Market
  • Test Service Revenue Breakdown for Major Companies
  • Evaluation of Test Services Products on the Market According to Five Checkpoints
  • Strategies for Success In Test Service Commercialization
  • Company Profiles
The report covers Clinical test services offered by reference laboratories, hospital laboratory outreach programs, direct to consumer web-based companies, and CLIA-registered company labs. The report describes the lay of the land for test services when they were first launched in the mid 1980s, the status quo in 2008 and a peek into the future.

What are the market factors driving test servicing? What companies are best suited for this strategy now and in the future? What are the best strategies, who has been most successful and where is this trend headed in the future? What are the areas of IVD most likely to be impacted by this trend.? This report answers these questions and more. Rosen's report will not only describe the market as it is today, but provide a clear picture - a roadmap - to how diagnostics will be practiced in this century.

Shara Rosen is Kalorama's lead diagnostic analyst and is the author of the Worldwide Market for In Vitro Diagnostics, 6th Edition., Physician Office Lab Markets,Point of Care Diagnostics and several other important diagnostic studies. This study is the result of her research and analysis and interviews with experts in the field.


CHAPTER ONE: EXECUTIVE SUMMARY

  • Scope and Methodology
  • Market Trends
  • Clinical Chemistry
  • Coagulation tests
  • Flow Cytometry
  • Histology/Cytology
  • Infectious Diseases
  • Keys to Success
CHAPTER TWO: INTRODUCTION
  • Background
  • The U.S. Versus Europe
  • ASRs
  • Hospital Outreach and National Reference Lab Services
  • Lab Outreach Testing
  • Independent Laboratories
  • Status quo and Future
  • Tests in Development
  • Serendepity or Strategy?
CHAPTER THREE: MARKET OVERVIEW/ SUPPLY ANALYSIS
  • Background
  • Market Analysis, revenue estimates 2007 - 2012
  • Testing Markets
  • ISC and ISH
  • Market and Growth
  • Market Share
  • Lab Launches and Acquisitions
  • Market Leaders
  • Evaluation of Lab Tests
    • Uniqueness
    • Need
    • Reimbursed
    • Incumbent
    • Recognized
    • Peer Reviewed
  • Competition from FDA Cleared Products
  • Cost
  • Competitive Technologies
  • Pathwork
  • BRCA analysis
  • Mammastatin
  • Limited Use of Molecular Testing for Colon Cancer.
  • TDT
  • Ovarian Cancer Testing
  • Future Leaders?
  • HIV Testing
  • Mental Illness
  • Test Services on the Horizon
CHAPTER FOUR: MARKET TRENDS/ DEMAND ANALYSIS
  • The Commercialization of Multiplexed and Complex Analyses
  • Opportunity Pricing and margins are attractive Demand for Esoteric Tests
CHAPTER FIVE: MARKET BARRIERS FOR TEST SERVICES
  • Regulatory affairs
  • Can the FDA Regulate New test Modalities?
  • IVDMIAs
  • Pending LDT Legislation
  • Reimbursement Imperative
  • Physician Uptake
  • Connectivity, a Force to Consider
  • The In Vivo - In Vitro Diagnostic Paradigm
  • Social media and Internet-Based Services
CHAPTER SIX: TESTS AND COMPANIES TO WATCH
  • 23andMe, Inc.
  • Key Comment
  • Details

  • Affymetrix
  • Key Comment
  • Details

  • Agendia B.V.
  • Key Comment
  • Details

  • A RUP Laboratories
  • Key Comment

  • Athena Diagnostics, Inc.
  • Key Comment
  • Details

  • Atherotech
  • Key Comment
  • Details

  • AviaraDx (formerly Arcturus Biosciences)
  • Key Comment
  • Details

  • Biomedical Diagnostics, LLC/Abviva, Inc.
  • Key Comment
  • Details

  • Biophysical Corporation
  • Key Comment
  • Details

  • Caris MPI
  • Key Comment

  • Clarient Inc. (formerly ChromaVision
  • Key Comment
  • Detail

  • Clinical Data, Inc
  • Key Comment
  • Details

  • CombiMatrix Molecular Diagnostics (CMDX)
  • Key Comment
  • Details

  • Consumer Genetic
  • Key Comment
  • Details

  • Corgenix Medical Corporatio
  • Key Comment
  • Details

  • Correlogic Systems, Inc
  • Key Comment
  • Details

  • deCode Genetics Inc.
  • Details

  • DiagnoCure
  • Key Comment
  • Details

  • DNA Direct, Inc.
  • Key Comment
  • Details

  • EXACT Sciences Corporation
  • Key Comment
  • Details

  • Exiqon A/S
  • Key Comment
  • Details

  • Focus Diagnostics, Inc.
  • Key Comment
  • Details

  • Genelex Corporation
  • Key Comment
  • Details

  • Genomic Health
  • Key Comment
  • Details

  • Genoptix, Inc.
  • Key Comment
  • Details

  • Genzyme Corporation
  • Details

  • InterGenetics, Inc.
  • Key Comment
  • Details

  • Knome, Inc.
  • Key Comment
  • Details

  • Lab21 Healthcare
  • Key Comment

  • Laboratory Corporation of America Holdings (LabCorp)
  • Key Comment
  • Details

  • LipoScience, Inc.
  • Key Comment
  • Details

  • Mayo Medical Laboratories
  • Key Comment
  • Details

  • Monogram Biosciences, Inc. (formerly ViroLogic)
  • Key Comment
  • Details

  • Myriad Genetics, Inc.
  • Key Comment
  • Details

  • NeuroMark
  • Key Comment
  • Details

  • Nuvera Biosciences
  • Key Comment
  • Details

  • Nymox Pharmaceuticals
  • Details

  • Oncolab, Inc.
  • Key Comment
  • Details

  • Panacea Pharmaceuticals, Inc.
  • Key Comment
  • Details

  • Pathway Diagnostics Corporation
  • Key Comment
  • Details

  • Pathwork Diagnostics (formerly Predicant Biosciences)
  • Key Comment
  • Details

  • Perceptronix Medical Inc.
  • Key Comment
  • Details

  • Power3 Medical Products, Inc.
  • Key Comment
  • Details

  • Precision Therapeutics, Inc.
  • Key Comment
  • Details

  • Prometheus Laboratories Inc.
  • Key Comment
  • Details

  • Psynomics Incorporated
  • Key Comment
  • Details

  • Quest Diagnostics Incorporated
  • Key Comment
  • Details

  • Rational Therapeutics
  • Key Comment
  • Details

  • Rosetta Genomics Ltd.
  • Key Comment
  • Details

  • Signature Genomic Laboratories, LLC
  • Key Comment
  • Details

  • Smart Genetics
  • Key Comment
  • Details

  • Specialty Laboratories
  • Key Comment
  • Details

  • SpectraCell Laboratories, Inc.
  • Key Comment
  • Details

  • Targeted Diagnostics & Therapeutics, Inc. (TDT)
  • Key Comment
  • Details

  • XDx Inc.
  • Key Comment
  • Details

CHAPTER SEVEN: CONCLUSION

  • Is There a Market for Test Services?
  • Strategies for Successful Market Entry

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

  • Figure 1-1: Sales of 7 Key IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components, 2007

  • Figure 1-2: Growth Rate 7 IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry) vs. Their Esoteric Components , 2007

  • Figure 1-3: Esoteric Test Service Revenues, Reference Labs and CLIA-registered Company Test Service Offerings, 2007 and 2012

CHAPTER TWO INTRODUCTION

  • Figure 2-1: Explosion of Test Capabilities 20th and 21st Century

CHAPTER THREE: MARKET OVERVIEW AND SUPPLY ANALYSIS

  • Table 3-1: Worldwide Esoteric Test Reagent Sales by Product Market, 2007

  • Figure 3-1: Esoteric Sales Across IVD Segments (Clinical Chemistry, Immunoassays, Radioimmunassays, Coagulation, Histology/Cytology, Nucelic Acid Assays, Flow Cytometry), 2007

  • Table 3-2: Worldwide Test Servcies Market

  • Table 3-3: Esoteric and Genomic Service Test Sales, Selected Companies (Company, Location, Area, 2005-2008 sales, % of Change)

  • Table 3-4: Selected CLIA- Registered Company Lab Tests Evaluated Selected CLIA- mRegistered Company Lab Tests Evaluated by Five Evaluation Points(Uniqueness, Need, Reimbursement, Incumbent Presence, Recognizable Technology)

  • Table 3-5: Selected CLIA-Registered Lab Test Services, 2007

CHAPTER FOUR: MARKET TRENDS AND DEMAND ANALYSIS

  • Table 4-1: Number of People Who Get Chronic Diseases Every Year

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