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
