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'ƵĂƌĂŶƚĞĞĚ IVD Industry
Each week, Contributing Editor Richard Park offers his
unique insights into the IVD sector in his blog, which is
featured in the IVD News electronic newsletter (go to
www.mdtmag.com/may1470 to subscribe). Following are
a number of excerpts that highlight some of his blogs with
links to the full versions on the MDT website.
Opportunities and Challenges of Doing Business
in Companion Diagnostics
For my occasional series of blogs examining various facets of the companion
diagnostics market, I asked some of the major IVD manufacturers to share
their thoughts and opinions on the current opportunities and challenges in
companion diagnostics. The following is presented in a panel discussion format. The panel participants are Trevor Hawkins, Senior Vice President, Strategy, Innovation, and Business Development at Siemens Healthcare Diagnostics;
George Maliekal, Senior Director, Business Development and Companion
Diagnostics at Abbott Diagnostics; and Helene Peyro-Saint-Paul, Personalized
Healthcare/Oncology Portfolio Team Lead at Qiagen GmbH.
The participants responded to the following questions:
• What are the growth opportunities in companion diagnostics for IVD
• What business challenges do IVD manufacturers encounter in developing,
marketing, and selling companion diagnostics?
• What technology challenges do IVD manufacturers encounter in developing companion diagnostics?
• How do IVD manufacturers overcome these technology challenges?
• What are the future business prospects in the companion diagnostics
Go to www.mdtmag.com/may1471 to read the full presentation.
Barriers to Companion Diagnostics: Market Sales and Clinical Utility
One of the fundamental barriers to adoption of an IVD test in a combination
product is the potential for limiting sales of the new therapeutic to a limited target population. The positive argument against this barrier is that a companion
diagnostic may allow commercialization of a new drug that might not otherwise
be approved, or rescue a drug that has demonstrated adverse effects in certain
patient groups. The counter argument is that the use of companion diagnostics
will limit the market, especially as competitors introduce drug products that are
more widely suitable and do not require a companion diagnostic.
Another significant barrier is the complexity of determining and validating
the clinical utility of combination diagnostic and therapeutic products. This
issue was first examined in the draft Preliminary Drug-Diagnostic Co-Develop-ment Concept Paper issued by FDA in April 2005 and discussed at the Fourth
FDA Workshop on Pharmacogenomics in Drug Development in December
2007. The scope of the concept paper was limited to validation of single bio-