Medical Device Link.

DX Directions: Developing Companion Diagnostics for Personalized Medicine

This new special report examines the critical issues regarding personalized medicine and the development of companion diagnostics, which could significantly affect the IVD industry's future.

In a series of articles by leading industry experts, this report will provide in-depth analysis of the following issues and discuss how they may be played out in the IVD industry:

• Technology. Challenges for IVD manufacturers to develop diagnostic technologies that can be implemented as companion diagnostics and used by clinicians to prescribe targeted therapies.
  Author: Harry Glorikian, managing partner, Scientia Advisors, and Aruna Rajan, associate at Scientia Advisors
  
  
• Business and Marketplace. Current market conditions, business landscape, and clinical areas that have the potential of benefiting the most from companion diagnostics.
  Author: Andrea Hiller, marketing manager, Kalorama Information
  
  
• Regulations. Current status of regulations for personalized medicine, and the regulatory requirements for companion diagnostics that IVD manufacturers must meet.
  Author: Paul Radensky, MD, JD, partner, McDermott Will & Emery LLP, Sheila Walcoff, JD, partner, McDermott Will & Emery LLP, and Eric Zimmerman, JD, partner McDermott Will & Emery LLP (Washington, DC)
  
  
• Reimbursement. Current status of reimbursement for personalized medicine, and the requirements that must be met to receive reimbursement for companion diagnostics.
  Author: Bruce Quinn, MD, PhD, senior health policy specialist in the government strategies practice at Foley Hoag LLP
  
  
• Society and Ethics. Discussion on how the societal and ethical issues regarding genetic testing will affect the use and development of companion diagnostics for personalized medicine.
  Author: Sharon Terry, president and CEO, Genetic Alliance