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Bioinformatics in IVD Testing

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SKU: KLI5060494 Category: Biotechnology Market Research Pages: 198
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Description

Computer diagnostics could offer opportunity for clinical laboratory professionals to add value to clinicians in diagnosing diseases. IT companies in collaboration with test vendors are developing computer software that complements the skills of human test interpretation.

This report, Bioinformatics in IVD Testing looks at the various IVD market segments where bionformatics is expected to have the most impact.

Bioinformatics-based testing has made a huge contribution to cancer diagnosis and therapy management.  In infectious disease diagnostics it allows the detection of difficult to culture pathogenic bacteria or viruses and to uncover the epidemiology of infections.  The bioinformatic analysis of mutations of known human genes is used to diagnose common disorders, inherited diseases, or different types of cancer and can indicate the prognosis of malignant diseases.

What developments are driving this trend?  What are labs and providers doing to incorporate these products into practice?  And how are payors and regulators reacting?  Who is partnering with who to deliver a solid combination product?  This report delves into these issues and provides an excellent round-up of the current status of bioinformatics in the IVD industry.

As part of its coverage, the report provides information on the following developments:

  • Selected Diagnostic Tests That Incorporate Bioinformatics
  • Selected Multiplexed Tissue-Based Cancer Tests
  • Selected Histology Analyses Software Tools
  • Selected Blood-Based Cancer Biomarker Tests That Use Software Analysis Tools
  • Selected Innovations in Bioinformatic-Based Tests For CVD
  • Selected Chronic Diseases Tests With Integrated Bioinformatics
  • Selected Innovations in Bioinformatic-Based Tests For Psychiatric Disorders
  • Selected Systems For Bioinformatics-Based Infectious Disease Testing
  • Selected Next Generation Sequencing Platforms

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 techniques presented in the report are expected to replace the standard of care in 2013, 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 report looks at the bioinformatics-based  product offerings and developments of the following companies, among others:

  • Abbott
  • Cannon
  • RocheAffymetrix Inc.
  • AssureRx Health, Inc.
  • Genomic Health, Inc.
  • Bio-Reference Laboratories, Inc. (BRLI)
  • Dako A/S
  • Siemens
  • Thermo Fisher
  • Gen-Probe
  • Medtronic Inc.
  • PerkinElmer, Inc.
  • Prometheus Labs
  • QIAGEN N.V.
  • Quest

Sophisticated lab instruments can produce detailed molecular and protein analyses that are reported as data points, bioinformatics-based tools integrated into these instruments convert these data points into patient specific reports.

In addition to surveying the many uses for bioinformatics in IVD, the report provides 2012 market estimates for the following IVD market segments

  • Histology/Cytology
  • Immunoassays
  • Molecular Assays
  • Mass Spec Clinical Tests and Services
  • Molecular Pharmacodiagnostics
  • Tissue Arrays
  • Circulating Tumor Cells

These are the segments most affected by bioinformatics.   The report also includes a conclusions section where analyst Shara Rosen interprets developments in the market to assess the commercial possibilities for bioinformatics in medicine.   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 and molecular pathologists.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

Introduction

Scope and Methodology

Market Trends

IVD Markets Most Affected by Bioinformatics

Advances in Lab Medicine

CHAPTER TWO: INTRODUCTION

Background

Bioinformatics-based Diagnostics

The Case for Bioinformatics

CHAPTER THREE: ENABLING TECHNOLOGIES AND COMMERCIALIZATION ARRANGEMENTS

Alliances and Collaborations

Major Partnerships

Advances in Clinical Bioinformatics

Reimbursement-Driven Health Data Analytics

Insurers, PBMs and Providers

The Interface and Test Technologies

Bioinformatics for Consumers

CHAPTER FOUR: MARKET ANALYSIS – BIOINFORMATICS-BASED DIAGNOSTICS

Background

The Commercial Outlook

Trends In Bioinformatics-Based Tests For Cancer

Technologies

Tissue-based Tests

Blood-Based Tests

Market-cleared Tests

Trends in Bioinformatics-based Tests for Diabetes

Trends in Bioinformatics-based Tests for Cardiovascular Disease

Trends in Bioinformatics-based Tests for Chronic Diseases

Arthritis

Gastrointestinal Conditions

Alzheimer’s Disease

Parkinson’s Disease

Psychiatric Disorders

Trends In Bioinformatics-Based Tests In Microbiology

Software Applications

Genome Sequencing

Mass Spectrometry

Trends in Bioinformatics-based Diagnostics for Prenatal Studies

The Commercial Outlook

CHAPTER FIVE: CONCLUSION

CHAPTER SIX: IVD COMPANIES AND BIOINFORMATIC-BASED OFFERINGS

23andMe

Affymetrix Inc.

Ameritox Ltd.

Aperio Technologies, Inc.

ArcticDx Inc.

Arrayit Diagnostics Inc.

AssureRx Health, Inc.

Atossa Genetics, Inc.

BG Medicine, Inc.

Biodesix, Inc.

BioImagene

Bio-Reference Laboratories, Inc. (BRLI)

bioTheranostics

Breath Testing at Home

CardioDx, Inc.

Children’s Hospital of Philadelphia:

Chronix Biomedical Inc.

CombiMatrix Molecular Diagnostics, Inc.

Complete Genomics

Crescendo Bioscience, Inc.

Dako A/S

deCode genetics ehf

Diaxonhit Group

DiaGenic ASA

DiaTech Oncology

Duke University Medical Center

Everist Genomics, Inc. (EGI)

Foundation Medicine. Inc

Genelex Corporation

Genomic Health, Inc.

Health Discovery Corporation (HDC)

Inform Genomics

Lab21 Limited

Life Technologies

Massachusetts Institute of Technology

Mayo Medical Laboratories

Medtronic Inc.

Metabolon Inc.

Omnyx, LLC

One Lambda, Inc.

Oregon Health & Science University (OHSU)

Pathogenica

Pathway Genomics

PerkinElmer, Inc.

PGXL Laboratories

Prometheus Laboratories Inc.

Qiagen N.V

Ridom GmbH

Selventa

Signal Genetics

Tethys Bioscience Inc.

Stanford University

University of Houston

XDx Inc. – Expression Diagnostics

CHAPTER SEVEN: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTS

Access Genetics

BioDiscovery, Inc.

CLC bio

CollabRx, Inc. (formerly Tegal Corp)

Definiens

eGenomics

GeneInsight LLC

GenomeQuest Inc.

IBM Corporation

Ingenuity Systems

Knome Inc.

NSilico

Personalis

Signature Mapping Medical Sciences, Inc.

Silicon Valley Biosystems (SV Bio)

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Selected Salient Developments For Now And The Future

Table 1-1: IVD Segments Potentially Most Affected By Bioinformatics-Based Tests

CHAPTER TWO: ENABLING TECHNOLOGIES AND COMMERCIALIZATION ARRANGEMENTS

Table 3-1: Selected Collaborations For Bioinformatics-Based Diagnostics

Table 3-2: Selected Open-Source Variant Annotation Software

Table 3-3: Selected Information Technology Innovations In Clinical Diagnostics

CHAPTER THREE: MARKET ANALYSIS – BIOINFORMATICS-BASED DIAGNOSTICS

Table 4-1: Selected Diagnostic Tests That Incorporate Bioinformatics

Table 4-2: Selected Multiplexed Tissue-Based Cancer Tests

Table 4-3: Selected Histology Analyses Software Tools

Table 4-4: Selected Blood-Based Cancer Biomarker Tests That Use Software Analysis Tools

Table 4-5: Selected Innovations In Bioinformatic-Based Tests For CVD

Table 4-6: Selected Chronic Diseases Tests With Integrated Bioinformatics

Table 4-7: Selected Innovations In Bioinformatic-Based Tests

For Psychiatric Disorders

Table 4-8: Selected Systems For Bioinformatics-Based Infectious Disease Testing

Table 4-9: Selected Next Generation Sequencing Platforms

Table 4-10: Ivd Segments Potentially Most Affected By Bioinformatics-Based Tests

 

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