By: Richard Park

Overall, there are currently two applications for companion diagnostic testing. The first is to narrow the field of applications for drugs in development. Second, companion diagnostics are used to select those therapeutics with the greatest efficacy and the least probability of harmful side effects for particular patients.

According to Kalorama Information (New York City), the trends and factors that are expected to influence the development and market introduction of companion diagnostics include the following:

• While there is a need for companion diagnostics, the full extent of that need is unknown at this time.

• The success of companion diagnostics depends on the progress of specific types of drug development.

• There is significant risk associated with developing companion diagnostics that is closely related to FDA approval of new drugs.

• Most companion diagnostics will be genome-based, with a smaller but not insignificant portion being proteome-based.

• While proteome-based companion diagnostics may provide the opportunity for expanded immunoassay use, this factor will still have its limitations.

• Companion diagnostics may allow pharmaceutical companies to charge premium prices for niche pharmaceuticals.

• Companion diagnostics may increase interest in the orphan drug markets.

• A key element in the acceptance of companion diagnostics will be the patient's perception of the process as genetic screening.

Taking into account such trends, this issue discusses some of the latest business and technology developments in companion diagnostics for personalized medicine.

The Deloitte Center for Health Solutions (Washington, DC) released a study examining personalized medicine's economic value proposition and the importance of return on investment (ROI) for multiple stakeholders, including IVD manufacturers, in advancing the adoption of personalized medicine (see Trends & Perspectives, page 14). In this report, Deloitte developed a framework for calculating personalized medicine's ROI by examining case studies categorized into two scenarios across a range of clinical conditions.

Author Marcel van Kasteel of Philips Handheld Immunoassays (Eindhoven, The Netherlands) discusses essential requirements for developing new tests for personalized healthcare successfully to the IVD market. His article, “Developing a Nanoparticle Technology for Patient-Centered Diagnosis and Treatment” (page 33), examines a new generation of handheld diagnostic devices that offer disease-specific testing at the protein level and can be performed at a time and place convenient for patients