Key Trends Fueling the Boom in Genetic Testing

Published by: Decision Resources

Published: Jun. 15, 2009

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

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 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.

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 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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