Key Trends Fueling the Boom in Genetic Testing
Published By: Decision Resources
June 2009
R55-651
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Description
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 fl ourishing 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.
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- 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 infl uence 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 infl uential 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 infl uencing 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.
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Table of Contents
- 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
- Figures
- 1. Potential Market Impact by Select Companies That Offer Novel Prenatal Diagnostics
- 2. Teams Competing for Archon X Prize for Genomics
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