 Spectrum --
June 2008
 Introduction:
Diagnostics can be used to identify subgroups of patients
who may or may not benefit from a companion drug, who may have adverse
reactions to that drug, or who may require different doses of that drug because
of their particular metabolic activity. The concept of companion diagnostics as
an integral component of personalized medicine--RxDx--is an emerging and critical
paradigm for drug development and use. What is driving that paradigm.
Get the Answers You Need to Shape Your Strategy:
 More than a dozen companion diagnostic tests are approved for
use in the United States and guide the prescription of products in oncology,
cardiovascular disease, and infectious diseases. What are the most
successful RxDx products, and will their success encourage further development?
Why are companies reluctant to abandon the blockbuster model in favor of
personalized medicine?
Personalized medicine continues to be heavily debated within the
industry, and future growth depends on more attention from all stakeholders. What
is each stakeholder’s role in RxDx collaborations, and how can these
collaborations drive development? What does each player have to offer the
others to encourage development and reconcile debate? Why are parallel
development programs critical?
Reimbursement issues are an important factor that will
determine whether the pharmaceutical industry is willing to invest in RxDx, but
current reimbursement policies can be discouraging. What evidence must
companies provide to third-party payers to demonstrate value and ensure
reimbursement? What are the policies and issues surrounding reimbursement? With
few RxDx products on the market and even fewer reimbursed, how can R&D
costs ever be recovered?
Scope:
Key players: Abbott Diagnostics, Clinical Data, Dako,
Genzyme Genetics.
Challenges in RxDx development: technological
challenges, regulation, drug labeling, reimbursement.
Emerging companion diagnostics by therapeutic area:
oncology, infectious diseases, cardiology, central nervous system (CNS)
indications, diabetes, respiratory therapeutics; profiles of select companies
working in RxDx.
Outlook: future of companion diagnostics development,
company buy-in, the affect of personalized medicine on prescription sales, the
role of regulatory agencies.
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