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

Table of Contents

• Scope and Methodology
• Market Trends
• Clinical Chemistry
• Coagulation tests
• Flow Cytometry
• Histology/Cytology
• Infectious Diseases
• Keys to Success

• 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?

• 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

• The Commercialization of Multiplexed and Complex Analyses
• Opportunity Pricing and margins are attractive Demand for Esoteric Tests

• 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

• 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

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

• 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

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

• 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

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