Key Trends Fueling the Boom in Genetic Testing

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.

• 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