Key Trends Fueling the Boom in Genetic Testing

Published by	Decision Resources, Inc.
Published	June, 2009	Product code	91143
Content info	30 Pages
Price	US $ 3450 PDF by E-mail (Global License)

Introduction
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Key Trends Fueling the Boom in Genetic Testing published by Decision Resources, Inc. in June, 2009. This report consists of 30 Pages and the price starts from US $ 3450.

Introduction

Abstract

Introduction

“Progress” aptly describes the expanding field of genetic testing. The field is more than finding linkages of genes with diseases: it encompasses technologies that have made it easier to quickly and more efficiently discover genetic markers that predict disease, diagnose disease, and guide prescribing. Applications of genetic tests are evolving as the technologies to refine them are improving - in addition to the typical diagnostic/biopharma client, interest is flourishing among vendors that are targeting consumer health. This combined push is creating strong incentives for select populations and payers to request such tests, which could translate to large payoffs for those driving genetic diagnostic development efforts.

Get the Answers You Need to Shape Your Strategy

Being able to dispense accurate prescribing information for patients to reduce negative side effects, increase compliance, and improve prognosis is a key goal of personalized medicine. How is genetic testing transforming the personalized medicine space?
Pharmaceutical companies use various strategies to secure the highly sought-after regulatory approval. Biomarker-based diagnostics can play (and have already demonstrated to an extent) an instrumental role in this journey. How can biomarker-based genetic tests influence the federal approval for pharmaceuticals? A handful of pharmaceutical companies have successfully used companion diagnostics; the looming question in this field is: How many will follow, and will this become a major strategy?
Breast cancer has emerged as a hotbed of development for personalized medicine, and it is no surprise that oncology is, by far, the most active arena for genetic testing. How can the successful use of genetic testing in breast cancer be mirrored in other disease states within and outside of oncology?
New legislation, payer involvement, and regulatory interest are among the key factors fueling the boom in genetic testing. How influential are they in development of new tests? What are the pitfalls for industry players in the genetic testing market?
Companies such as Hologic, Quest, LabCorp, and Sonic Healthcare were responsible for dozens of acquisitions up through 2008, but M&A activity for biomarkers and diagnostics companies was essentially null in the first quarter of 2009. How has the present economic situation affected investment in genetic testing? Why should companies consider seeking innovation through partnership?

Scope

Key factors influencing biopharmaceutical innovation: gene-based targeted therapies and companion diagnostics, the need to avoid adverse drug reactions, building better clinical trials, personalized medicine, federal commitment.
Two Spectrum Expert Commentaries: one details the value of investing in genetic testing companies, and the other provides a perspective on approval strategies for gene-based companion diagnostic tests.
Information on genetic variance studies: salient findings from clinical studies for select genes under investigation for drug and diagnostic development.
Analysis of key issues affecting growth of the genetic testing market: large-scale genetic studies, next-generation sequencing, GINA, regulatory perspectives, reimbursement, branding, DTC advertising, economic climate.

Mentioned in This Report

Companies

23 and Me
Abbott Molecular
Agendia
Amgen
Applied Genomics
Arca Biopharma
Aviara Diagnostics
Biocept Laboratories
Bio-Reference Laboratories
Bristol-Myers Squibb
BTG
Celera
Chugai
Clarient
Clinical Data
Combimatrix Molecular Diagnostics
Correlagen
Dako
deCode
Delphic Diagnostics
DNA Direct
Eli Lilly
eXagen
Genelex
Genentech
Genomic Health
Genzyme Genetics
GlaxoSmithKline
Ikonisys
Knome
Laboratory Corp. of America
Monogram Biosciences
Myriad Genetics
Nanosphere
Navigenics
NeoGenomics
Novartis
OSI
Osmetech Molecular Diagnostics
ParagonDX
PerkinElmer
Pfizer
Plasmagene Biosciences
Prometheus Laboratories
Quest Diagnostics
Roche
Roche Molecular Diagnostics
SanofiAventis
Sciona
Sequenom
Signature Genomic Laboratories
Third Wave Technologies
Vysis/Abbott
Xenomics

Executive Summary
- Strategic Considerations
- Stakeholder Implications
Introduction
Connecting the Dots: Gene to Disease
- Genetic Variation Is Key to Novel Developments
- Potential to Address Broader Unmet Needs
Individualizing Personal Genomics.
Rekindling Pharmacogenomics
Personalized Medicine as a Driver for Growth
- Targeted Therapies and Companion Diagnostics
- Fueling Interest in Other Therapy Areas
- Turning Yesterday' s Failures into Today' s Personalized Medicine Success Stories
  - Bucindolol
  - Vilazodone
Creating Sustainable Growth in the Field
- Refine Next-Generation Sequencing Technologies
- Correctly Navigate the Approval Process
  - Amgen' s Vectibix - A Cautionary Tale
  - Pfizer' s Selzentry and Monogram Biosciences' Trofile
- Capitalize on Recent Legislative Support
- Effectively Engage Payers for Novel Tests
- Push for Large-Scale Genomic Studies
- Gracefully Ride Out the Economic Crisis
Conclusions

Expert Commentaries

Finding Value in Genetic Testing
A Perspective on Approval Strategies for Gene-Based Companion Diagnostics
Keith F. Batchelder, M.D., CEO and Founder, Genomic Health Care Strategies.

Sidebar

Impact of the Economic Crisis on Emerging Diagnostics Companies

Tables

1. Select Genetic Testing Companies
2. Select Prenatal Diagnostic Tests for Genetic Analysis
3. Select Findings from Recent Genetic Variation Studies
4. Select Personal Genomics Services and Costs
5. Select Gene-Based Companion Diagnostic Tests for Breast Cancer
6. Targeted Therapies for Which Genetic Testing May Be Useful to Guide Prescribing
7. Select Genetic Companion Diagnostic Tests and Associated Therapeutics
8. Select Large-Scale Genetic Variation Studies