Publications by Biophoenix' Principals

Smarter Ways to Diagnose Cardiovascular and Heart Disease.
Publisher:PJB Publications Ltd
Year of publication:2003
Type of publication:Management report
Publisher's reference (if any):CBS907
Author(s):Sreten Bogdanovic and Beata Langlands
Approximate page count:200
Price when published:£750
Remarks:
  1. Page numbers, where given, refer to the draft manuscript (which may differ from the published version).
  2. The copyright in this report is owned by the publisher, to whom any requests for copies should be addressed.
  3. The price shown is for a single copy of the print version. Multiple copies and electronic copies usually have different prices.
            SMARTER WAYS TO DIAGNOSE CARDIOVASCULAR AND HEART DISEASE

                               TABLE OF CONTENTS

         LIST OF TABLES

         LIST OF FIGURES

         ABBREVIATIONS

         EXECUTIVE SUMMARY

         SCOPE AND METHODOLOGY

         S.1  Scope of this report
         S.1  Background research
         S.3  Methodology of market calculations

         CHAPTER 1   INTRODUCTION

         1.1  Introduction to the in vitro diagnostic industry
            1.1.1  In vitro diagnostic technology segments
            1.1.2  Advances in in vitro diagnostic technologies
               1.1.2.1  Immunoassays
               1.1.2.2  Nucleic acid testing
            1.1.3  Point-of-care testing
            1.1.4  New uses for in vitro diagnostic tests
               1.1.4.1  Theranostic tests
               1.1.4.2  Genetic predisposition tests

         1.2  Cardiovascular and cerebrovascular disease
            1.2.1  Coronary artery disease
               1.2.1.1  Background on atherosclerosis
               1.2.1.2  Diagnosis
               1.2.1.3  Treatments
            1.2.2  Myocardial infarction
               1.2.2.1  Diagnosis
               1.2.2.2  Treatments
            1.2.3  Peripheral vascular disease
            1.2.4  Congestive heart failure
            1.2.5  Stroke

         1.3  Conditions which increase cardiovascular risk
            1.3.1  Diabetes mellitus
            1.3.2  Other common conditions

         1.4  Cardiovascular drug therapies
            1.4.1  Anti-hyperlipidaemic drugs
            1.4.2  Anti-thrombotics
            1.4.3  Platelet inhibitors

         1.5  In vivo tests of cardiovascular function

         1.6  Overview of cardiovascular in vitro diagnostics
            1.6.1  Lipid panels/risk assessment markers
            1.6.2  Cardiac markers
            1.6.3  Haemostasis tests
            1.6.4  Genetic tests

         1.7  Discovery of new biomarkers

         CHAPTER 2   PRODUCTS IN THE CARDIOVASCULAR DIAGNOSTIC MARKET

         2.1  Atherosclerosis
            2.1.1  Lipids and lipoproteins
               2.1.1.1  Cholesterol
               2.1.1.2  Skin cholesterol
               2.1.1.3  Interstitial fluid cholesterol
               2.1.1.4  Oxidised low-density lipoproteins
               2.1.1.5  Low-density lipoprotein subfractions
               2.1.1.6  Apolipoprotein B and apolipoprotein A-1
               2.1.1.7  Lipoprotein (a)
               2.1.1.8  Sphingolipids
            2.1.2  Markers of inflammation
               2.1.2.1  C-reactive protein
               2.1.2.2  Fibrinogen
               2.1.2.3  Lipoprotein-associated phospholipase A2
               2.1.2.4  Activated complement
               2.1.2.5  Activated Factor XII
            2.1.3  Homocysteine
            2.1.4  Anti-phospholipid antibodies
            2.1.5  Urinary albumin
            2.1.6  Asymmetric dimethylarginine
            2.1.7  Other markers

         2.2  Myocardial infarction
            2.2.1  Markers of thrombosis
               2.2.1.1  Thrombosis precursor protein
               2.2.1.2  Monocyte-platelet complex
            2.2.2  Markers of ischaemia
               2.2.2.1  Ischaemia-modified albumin
               2.2.2.2  Sphingolipids
            2.2.3  Markers of necrosis
               2.2.3.1  Myoglobin
               2.2.3.2  Cardiac-specific myoglobin
               2.2.3.3  Fatty acid-binding protein
               2.2.3.4  Glycogen phosphorylase BB
               2.2.3.5  Creatine kinase-MB
               2.2.3.6  Troponins: redefining myocardial infarction
               2.2.3.7  Use of multiple markers

         2.3  Congestive heart failure
            2.3.1  B-type natriuretic peptide

         2.4  Stroke
            2.4.1  Diagnostic and prognostic markers

         2.5  Haemostasis
            2.5.1  Immunoassays
               2.5.1.1  D-Dimer
            2.5.2  Monitoring antithrombotic agents
               2.5.2.1  Heparin
               2.5.2.2  Warfarin
            2.5.3  Antiplatelet agents

         2.6  New biomarker discovery

         CHAPTER 3   GENETIC MARKER TESTS

         3.1  Genes and cardiovascular disease

         3.2  Genetic markers in hypertension
            3.2.1  Angiotensinogen gene
            3.2.2  Other genes

         3.3  Genetic markers in haemostasis
            3.3.1  Factor V gene
            3.3.2  Methylenetetrahydrofolate reductase gene
            3.3.3  Factor II gene or prothrombin gene
            3.3.4  Platelet glycoprotein Ia gene
            3.3.5  Glycoprotein IIIa gene
            3.3.6  Angiotensin-converting enzyme gene
            3.3.7  Hypercoagulation disorder panel

         3.4  Haemochromatosis gene

         3.5  Interleukin-1 gene

         3.6  Miscellaneous gene markers

         3.7  Periodontitis risk test

         3.8  Diabetes complications test

         3.9  Responsiveness to statins

         3.10  Responsiveness to other drugs

         CHAPTER 4   THE GLOBAL MARKET

         4.1  Introduction

         4.2  Overview of the global markets
            4.2.1  Demographic data
            4.2.2  Population ageing
            4.2.3  Economic climate
            4.2.4  Incidence of cardiovascular disease
            4.2.5  The global market for in vitro diagnostic products
            4.2.6  Comparison of the regional markets

         4.3  Industry trends
            4.3.1  Laboratory testing market
            4.3.2  Point-of-care market
            4.3.3  Over-the-counter market
            4.3.4  Cardiovascular drug market
            4.3.5  Personalised medicine
            4.3.6  Market hurdles

         4.4  Market forecasts
            4.4.1  Current size of the cardiovascular diagnostics industry
            4.4.2  Five-year forecasts by segment
               4.4.2.1  Segment 1-lipid panels/metabolic risk assessment
                        markers
               4.4.2.2  Segment 2-cardiac markers
               4.4.2.3  Segment 3-haemostasis tests
               4.4.2.4  Segment 4-genetic tests
            4.4.3  Other tests
            4.4.4  Point-of-care market

         4.5  The industry players and their strategies

         CHAPTER 5   THE US MARKET

         5.1  Introduction

         5.2  Demographic details

         5.3  Health services

         5.4  The burden of cardiovascular disease

         5.5  Preventive healthcare

         5.6  Regulation of in vitro diagnostics by the FDA
            5.6.1  510(k) approval procedure
            5.6.2  PMA approval procedure
               5.6.2.1  Recent initiatives
            5.6.3  Post-market regulations

         5.7  The in vitro diagnostics market

         5.8  The cardiovascular in vitro diagnostics market
            5.8.1  Five-year forecasts

         5.9  Laboratory testing industry
            5.9.1  Federal regulation
               5.9.1.1  CLIA certification
            5.9.2  Third party reimbursement
               5.9.2.1  Medicare reforms
            5.9.3  The impact of managed care

         5.10   Transatlantic trade in medical technologies

         CHAPTER 6   THE EUROPEAN MARKET

         6.1  Introduction to the European market
            6.1.1  The burden of cardiovascular disease
            6.1.2  Laboratory testing recommendations
            6.1.3  The European in vitro diagnostic market
               6.1.3.1  Company market shares
               6.1.3.2  Regional market shares
               6.3.1.3  Market share by segment
               6.3.1.4  5-year forecasts for the European cardiovascular
                        diagnostics market
            6.1.4  EC IVD Directive
            6.1.5  EU-US mutual recognition agreement

         6.2  Germany
            6.2.1  Introduction
            6.2.2  Demographic details
            6.2.3  The burden of cardiovascular disease
            6.2.4  Health services
               6.2.4.1  Financing of healthcare
            6.2.5  The in vitro diagnostic market
               6.2.5.1  Forecasts for the German cardiovascular in vitro
                        diagnostic market

         6.3  Italy
            6.3.1  Introduction
            6.3.2  Demographic details
            6.3.3  The burden of cardiovascular disease
            6.3.4  Health services
               6.3.4.1  Financing of healthcare
            6.3.5  The in vitro diagnostic market
               6.3.5.1  Forecasts for the Italian cardiovascular in vitro
                        diagnostics market

         6.4  France
            6.4.1  Introduction
            6.4.2  Demographic details
            6.4.3  The burden of cardiovascular disease
            6.4.4  Health services
               6.4.4.1  Financing of healthcare
            6.4.5  The in vitro diagnostic market
               6.4.5.1  Forecasts for the French cardiovascular in vitro
                        diagnostic market

         6.5  Spain
            6.5.1  Introduction
            6.5.2  Demographic details
            6.5.3  The burden of cardiovascular disease
            6.5.4  Health services
               6.5.4.1  Financing of healthcare
            6.5.5  The in vitro diagnostic market
               6.5.5.1  Forecasts for the Spanish cardiovascular in vitro
                        diagnostics market

         6.6  UK
            6.6.1  Introduction
            6.6.2  Demographic details
            6.6.3  The burden of cardiovascular disease
            6.6.4  Health services
               6.6.4.1  Financing of healthcare
            6.6.5  The in vitro diagnostics market
               6.6.5.1  Forecasts for the UK cardiovascular in vitro
                        diagnostics market

         6.7  Rest of Europe
            6.7.1  Introduction
            6.7.2  Demographic details
            6.7.3  Forecasts for the cardiovascular in vitro diagnostics market
                   in the EEA

         CHAPTER 7   THE JAPANESE MARKET

         7.1  Japan
            7.1.1  Introduction
            7.1.2  Demographic details
            7.1.3  The burden of cardiovascular disease
            7.1.4  Health services
               7.1.4.1  Financing of healthcare
            7.1.5  Regulation of medical products
               7.1.5.1  Deregulation issues
            7.1.6  The in vitro diagnostic market
               7.1.6.1  Forecasts for the Japanese cardiovascular in vitro
                        diagnostics market

         CHAPTER 8   EMERGING MARKETS IN THE REST OF THE WORLD

         8.1  Emerging markets

         8.2  Forecasts for cardiovascular in vitro diagnostics in the rest
              of the world
            8.3.1  China
            8.3.2  India
            8.3.3  Latin America
               8.3.3.1  The spectre of cardiovascular disease

         CHAPTER 9   COMPANY PROFILES

         9.1  Axis-Shield plc
            9.1.1  Financial highlights
            9.1.2  Company overview
            9.1.3  Company strategy
            9.1.4  Cardiovascular laboratory in vitro diagnostics
               9.1.4.1  Homocysteine ELISA
               9.1.4.2  Activated Factor XII ELISA
               9.1.4.3  Cardiolipin IgG and IgM ELISA
            9.1.5  Point-of-care in vitro diagnostics
               9.1.5.1  NycoCard tests
               9.1.5.2  Haemostasis products
            9.1.6  In vitro diagnostic products in development

         9.2  Biosite Inc
            9.2.1  Financial highlights
            9.2.2  Company overview
            9.2.3  Company strategy
            9.2.4  Immunoassay testing platforms
               9.2.4.1  Antibody and analyte production
               9.2.4.2  Protein array technology
               9.2.4.3  Product platforms
            9.2.5  Cardiovascular point-of-care in vitro diagnostics
               9.2.5.1  The Triage Cardiac System
               9.2.5.2  The Triage BNP System
               9.2.5.3  Products under development
            9.2.6  Collaborations

         9.3  Cholestech Corporation
            9.3.1  Financial highlights
            9.3.2  Company overview
            9.3.3  Company strategy
            9.3.4  The LDX multi-analyte testing system
            9.3.5  Cardiovascular point-of-care in vitro diagnostics
               9.3.5.1  Launched cassette products
               9.3.5.2  Cassette products under development
            9.3.6  Collaborations

         9.4  Dade Behring Holdings Inc
            9.4.1  Financial highlights
            9.4.2  Company overview
            9.4.3  Company strategy
            9.4.4  Chemistry/immunochemistry platforms
            9.4.5  Cardiovascular laboratory in vitro diagnostics
               9.4.5.1  Cardiac marker tests
               9.4.5.2  High Sensitivity C-reactive protein assay
               9.4.5.3  Haemostasis products
            9.4.6  Cardiovascular point-of-care in vitro diagnostics
               9.4.6.1  Stratus CS Cardiac system
               9.4.6.2  Second-generation troponin T test
               9.4.6.3  Point-of-care PFA-100
            9.4.7  In vitro diagnostics products under development

         9.5  Diagnostic Products Corp
            9.5.1  Financial highlights
            9.5.2  Company overview
            9.5.3  Company strategy
            9.5.4  IMMULITE immunoassay platforms
            9.5.5  Cardiovascular laboratory in vitro diagnostics
               9.5.5.1  IMMULITE/IMMUNITE 2000 cardiac menu

         9.6  Genaissance Pharmaceuticals Inc
            9.6.1  Financial highlights
            9.6.2  Company overview
            9.6.3  Company strategy
            9.6.4  HAP technology platform
            9.6.5  Informatics technology platform
            9.6.6  STRENGTH trials
            9.6.7  Collaborations

         9.7  Interleukin Genetics Inc
            9.7.1  Financial highlights
            9.7.2  Company overview
            9.7.3  Company strategy
            9.7.4  Interleukin-1 technology platform
            9.7.5  TARxGET cardiovascular programme
            9.7.6  Cardiovascular laboratory in vitro diagnostics
               9.7.6.1  Periodontitis susceptibility test
               9.7.6.2  Diabetes complications test
            9.7.7  Collaborations

         9.8  International Medical Innovations Inc
            9.8.1  Financial highlights
            9.8.2  Company overview
            9.8.3  Company strategy
            9.8.4  Cardiovascular point-of-care in vitro diagnostics
               9.8.4.1  Cholesterol 1,2,3 skin test
            9.8.5  Collaborations

         9.9  i-STAT Corporation
            9.9.1  Financial highlights
            9.9.2  Company overview
            9.9.3  Company strategy
            9.9.4  I-STAT System
            9.9.5  Cardiovascular point-of-care in vitro diagnostics
               9.9.5.1  Coagulation test
               9.9.5.2  Coagulation tests under development
               9.9.5.3  Cardiac tests under development

         9.10   Myriad Genetics Inc
            9.10.1  Financial highlights
            9.10.2  Company overview
            9.10.3  Company strategy
            9.10.4  Proteomic technologies
            9.10.5  Cardiovascular laboratory in vitro diagnostics products
               9.10.5.1  CardiaRisk predictive test
            9.10.6  Collaborations

         9.11   PharmaNetics Inc
            9.11.1  Financial highlights
            9.11.2  Company overview
            9.11.3  Company strategy
            9.11.4  The TAS analyser and test cards
            9.11.5  Cardiovascular point-of-care in vitro diagnostics
               9.11.5.1  FDA-cleared haemostasis tests
               9.11.5.2  Haemostasis tests under development
            9.11.6  Collaborations

         9.12   Response Biomedical Corporation
            9.12.1  Financial highlights
            9.12.2  Company overview
            9.12.3  Company strategy
            9.12.4  RAMP technology
            9.12.5  Cardiovascular point-of-care in vitro diagnostics
               9.12.5.1  RAMP Myoglobin Assay System
               9.12.5.2  RAMP Heart Attack Test
               9.12.5.3  Other tests

         9.13   Spectral Diagnostics Inc
            9.13.1  Financial highlights
            9.13.2  Company overview
            9.13.3  Company strategy
            9.13.4  Immunoassay technologies
            9.13.5  Cardiovascular point-of-care in vitro diagnostics
               9.13.5.1  Cardiac STATus tests
               9.13.5.2  Cardiac STATus Rapid Panel Tests
               9.13.5.3  Cardiac STATus Troponin I
               9.13.5.4  Cardiac STATus CK-MB/Myoglobin
               9.13.5.5  Cardiac specific myoglobin test

         9.14   SYN-X Pharma Inc
            9.14.1  Financial highlights
            9.14.2  Company overview
            9.14.3  Company strategy
            9.14.4  Proteomics Discovery Platform
            9.14.5  Cardiovascular laboratory in vitro diagnostics products
            9.14.6  Cardiovascular point-of-care in vitro diagnostics
               9.14.6.1  Nexus Dx congestive heart failure test
               9.14.6.2  NeuroTrak point-of-care stroke diagnostic
            9.14.7  Collaborations

         9.15   Thoratec Corp
            9.15.1  Financial highlights
            9.15.2  Company overview
            9.15.3  Company strategy
            9.15.4  Cardiovascular point-of-care in vitro diagnostics
               9.15.4.1  Blood coagulation testing products
               9.15.4.2  ProTime Microcoagulation System

         REFERENCES

         APPENDIX A.1   Diagnostic product data

         LIST OF TABLES

         Table 1.1  Selected drugs used in the treatment of cardiovascular
                    disease

         Table 3.1  Human genes associated with cardiovascular disorders

         Table 4.1  World in vitro diagnostics market by area
         Table 4.2  Growth of the cardiovascular IVD market by segment,
                    2001-2007
         Table 4.3  Growth of the cardiovascular IVD market by country,
                    2001-2007

         Table 5.1  Cardiovascular mortality rates (deaths per 100,000
                    population) in the US, 1970-1997
         Table 5.2  Growth of the US cardiovascular IVD market, 2001-2007
         Table 5.3  Selected hospital, independent and total CLIA-registered US
                    testing sites by type, 1996-1999

         Table 6.1  Cardiovascular mortality in Europe per 100,000 population,
                    1970-1999
         Table 6.2  Principal European IVD markets, 2000
         Table 6.3  European clinical laboratory segments (Euros million), 2000
         Table 6.4  European laboratory subgroups (Euros million), 2000
         Table 6.5  Cardiovascular diagnostics market by European country in
                    2001 and 2007
         Table 6.6  Cardiovascular diagnostics forecasts for all of Europe,
                    2001-2007
         Table 6.7  Cardiovascular mortality in Germany per 100,000 population
         Table 6.8  Cardiovascular diagnostics forecasts for Germany, 2001-2007
         Table 6.9  Cardiovascular mortality in Italy per 100,000
         Table 6.10  Cardiovascular diagnostics forecasts for Italy, 2001-2007
         Table 6.11  Cardiovascular mortality in France per 100,000 population
         Table 6.12  Cardiovascular diagnostics forecasts for France,
                     2001-2007
         Table 6.13  Cardiovascular mortality in Spain per 100,000 population
         Table 6.14  Cardiovascular diagnostics forecasts for Spain, 2001-2007
         Table 6.15  Cardiovascular mortality in the UK per 100,000 population
         Table 6.16  Cardiovascular diagnostics forecasts for the UK,
                     2001-2007
         Table 6.17  Cardiovascular mortality in the EEA per 100,000
                     population
         Table 6.18  Cardiovascular diagnostics forecasts for other EEA
                     countries, 2001-2007

         Table 7.1  Cardiovascular mortality in Japan per 100,000 population
         Table 7.2  Cardiovascular diagnostics forecasts for Japan, 2001-2007

         Table 8.1  Cardiovascular diagnostics forecasts for the rest of the
                    world, 2001-2007

         Table 9.1  Axis Shield's financial highlights, 1999-2001 ($ million)
         Table 9.2  Biosite's financial highlights, 1999-2001 ($ million)
         Table 9.3  Cholestech's financial highlights, 2000-2002 ($ million)
         Table 9.4  Dade Behring Holdings' financial highlights, 1999-2001
                    ($ million)
         Table 9.5  Diagnostic Products' financial highlights, 1999-2001
                    ($ million)
         Table 9.6  Genaissance Pharmaceuticals' financial highlights,
                    1999-2001 ($ million)
         Table 9.7  Interleukin Genetics' financial highlights, 1999-2001
                    ($ million)
         Table 9.8  International Medical Innovations' financial highlights,
                    1999-2001 (Can$ million)
         Table 9.9  i-STAT's financial highlights, 1999-2001($ million)
         Table 9.10  Myriad Genetics' financial highlights, 2000-2002
                     ($ million)
         Table 9.11  PharmaNetics' financial highlights, 1999-2001 ($ million)
         Table 9.12  Response Biomedical's financial highlights, 2000-2001
                     (Can$ million)
         Table 9.13  Spectral Diagnostics' financial highlights, 2001-2002
                     (Can$ million)
         Table 9.14  SYN-X Pharma's financial highlights, 1999-2001
                     (Can$ million)
         Table 9.15  Thoratec's financial highlights, 1999-2001 ($ million)

         Table A.1  Cardiovascular diagnostic products given a CLIA
                    classification on or after 1 January 1999

         LIST OF FIGURES

         Figure 2.1  Simplified illustration of major coagulation pathways

         Figure 4.1  The regional population aged 65 years and over,
                     2000-2020 (million)
         Figure 4.2  Worldwide IVD market
         Figure 4.3  Market share of IVD market, by country
         Figure 4.4  Growth of the global cardiovascular IVD market by segment,
                     2001-2007

         Figure 5.1  Midyear Population Estimates for 2000 and 2025
         Figure 5.2  Growth of the US Cardiovascular IVD Market, 2001-2007
         Figure 5.3  Laboratory testing industry by market share

         Figure 6.1  The European cardiovascular diagnostics forecasts for all
                     of Europe, 2001-2007
         Figure 6.2  Germany's population estimates, 2000-2025 (thousands)
         Figure 6.3  Cardiovascular diagnostics forecasts for Germany,
                     2001-2007 ($ million)
         Figure 6.4  Population estimates for Italy, 2000-2025 (thousands)
         Figure 6.5  Cardiovascular diagnostics forecasts for Italy, 2001-2007
                     ($ million)
         Figure 6.6  The population forecasts for France, 2000-2025
                     (thousands)
         Figure 6.7  Cardiovascular diagnostics forecasts for France, 2001-2007
         Figure 6.8  Population forecasts for Spain, 2000-2025 (thousands)
         Figure 6.9  Cardiovascular diagnostics forecasts for Spain, 2001-2007
                     ($ million)
         Figure 6.10  Population forecasts for the UK, 2000-2025 (thousands)
         Figure 6.11  The UK's cardiovascular diagnostic market forecasts,
                      2001-2007 ($ million)
         Figure 6.12  Cardiovascular diagnostics forecasts for other EEA
                      countries, 2001-2007 ($ million)

         Figure 7.1  The population forecasts for Japan, 2000-2025
                     (thousands)
         Figure 7.2  Causes of death in Japan, 2000
         Figure 7.3  Cardiovascular diagnostics forecasts for Japan, 2001-2007
                     ($ million)

         Figure 8.1  Cardiovascular diagnostics forecasts for the rest of the
                     world, 2001-2007 ($ million)
         Figure 8.2  The Population forecasts for China, 2000-2025 (thousands)
         Figure 8.3  The population forecasts for India, 2000-2025
                     (thousands)
         Figure 8.4  Estimated numbers of automated, semi-automated and manual
                     clinical laboratories in Latin America

EXECUTIVE SUMMARY

Although a wide variety of in vivo diagnostic (IVD) tests and tools are available for probing cardiovascular function, these conventional techniques are costly and time consuming, and have very limited predictive potential. Smarter ways of assessing cardiovascular function rely on in vitro measurements of various biomarkers. Often the smarter approach is also to perform these tests at point-of-care (POC) sites, rather than in a central laboratory.

The cardiovascular IVD market represents one of the largest sectors within the IVD industry, chiefly due to the high prevalence rate and mortality of cardiovascular disease. The cardiovascular IVD market is creating growth opportunities both for established suppliers as well as new entrants into the market. Growth in this market is also being accelerated by the availability of new therapies.

Cardiovascular IVDs currently account for around 10% ($2.1 billion) of the global IVD market. We predict that the cardiovascular IVD market will grow considerably faster than the industry average, at an annual growth rate of 19.6%, reaching a value of $6.2 billion in 2007.

Since the mid-1990s, sales of cholesterol and lipid profile testing for cardiovascular disease risk have continued to increase and will continue to do so throughout 2002-2007. Developments in this area, including non-invasive cholesterol tests are discussed. These tests are increasingly aimed at the POC market. Although total cholesterol and high- and low- density cholesterol levels have long served as the primary indicators of risk for coronary artery disease, they miss 50% of people who ultimately suffer myocardial infarction (MI).

It is now known that several biomolecules and processes are involved in the formation of an atherosclerotic plaque, its transformation into unstable plaque, thrombus formation and plaque expansion. To detect more persons with an elevated risk, test developers have been turning to newer risk factors. Recently launched tests in this segment include: lipoprotein fractions, apolipoproteins B and A-1; lipoprotein (a); C-reactive protein; fibrinogen; homocysteine and activated factor XII. A number of tests are currently making a successful transition from clinical research to the clinical setting. Many other potential risk assessment markers are under active evaluation. There is likely to be considerable scope for manufacturers to introduce products based on panels of different biomarkers.

Rupture of an atherosclerotic plaque can lead to MI. IVD tests for the diagnosis of MI on the market are based on cardiac markers of necrosis. One of these markers, troponin, is rapidly becoming the new gold standard for the diagnosis of MI. Current development efforts in the industry focus on portable POC systems for the detection of multiple cardiac markers of necrosis which are capable of providing rapid qualitative results. Other markers of necrosis are under investigation. The industry has also been seeking earlier markers of MI, including markers of active thrombosis and of ischaemia. New biomarkers, which may aid the diagnosis of congestive heart failure and stroke, are also discussed.

Haemostasis is a critical component of cardiovascular disease. Several D-dimer immunoassays are now commercially available for exclusion of deep vein thrombosis or pulmonary embolism. Anticoagulants and anti-platelet agents play an increasingly important role in the management of cardiac patients and treatment with these drugs must be closely monitored. Recently introduced tests can detect the earliest stages of clot formation or quantify the level of platelet function, and these tests are increasingly aimed at the POC market.

This report also reviews current attempts to identify genetic markers that could form the basis of viable commercial products. Rapid progress is being made in the discovery and validation of single nucleotide polymorphisms associated with cardiovascular disease. Nucleic acid testing products for the determination of susceptibility to cardiovascular disease and responsiveness to cardiovascular drugs have begun to make an appearance on the market.

A world population that is getting richer and older faces an increased cardiovascular disease burden. Demographic data and incidences of cardiovascular disease throughout the world are tabulated and their implications discussed in this report. Established and expanding geographic markets for cardiovascular IVDs are profiled. Growth forecasts to 2007 are given for all the major cardiovascular IVD product segments within each geographic market.



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