 Spectrum --
March 2007
 Introduction:
Molecular diagnostics (MDx) is becoming increasingly
entwined with the development of pharmaceutical drugs. Initially, it was used
in clinical settings to aid diagnosis, prognosis, and optimal treatment, but
now, backed by regulatory authorities, it is becoming important in the
development and commercialization of new and existing therapies. As a result,
the MDx industry, already a multibillion-dollar market, will continue to expand
at a significant pace.
Get the Answers You Need to Shape Your Strategy:
 The MDx market can be segmented into three phases: infectious
diseases; blood screening; and pharmacogenomic testing, genetic testing,
predictive testing, and companion diagnostics. Why does scope for greater
innovation and greater sales potential lie in the third phase?
According to industry experts, polymerase chain reaction (PCR)
technology will have the greatest impact on the MDx market. PCR enables
researchers to amplify minute amounts of genetic material to billions of copies
in a matter of hours through repeated cycles of duplication via the use of an
enzyme called DNA polymerase or Taq polymerase. What big pharma company used
PCR to become one of the most powerful leaders in the field of MDx?
Pharmaceutical companies have traditionally been reluctant to
employ MDx (e.g., to identify biomarkers) to screen drug candidates during the
R&D process for fear of reducing the potential target population. Why is
this attitude changing?
Big pharmaceutical companies and smaller MDx companies are
teaming up to produce MDx technologies. What alliances have been formed, and
what products have been the result?
Scope:
The three phases of MDx: infectious diseases; blood
screening; and pharmacogenomic testing, genetic testing, predictive testing,
and companion diagnostics.
MDx technologies: PCR, DNA methylation, and RNAi
validation.
MDx platforms: Microarrays, nanoarrays, microfluidics,
and multiplex assays.
Major players: Roche Diagnostics, Abbott Diagnostics,
and Siemens Medical Solutions Group.
Expert Commentary: Dr. John Sninsky, vice president of
discovery research at Celera, and Dr. David Speechly, Media and Investor Relations at Celera, discuss Celera’s
involvement in MDx.
Related Spectrum Reports:
The Role of Pharmacogenomics in Personalized Medicine
In Vitro Diagnostics Deals: Therapeutic Area Trends
Codeveloping Targeted Therapies and Diagnostics: What’s in It
for Me?
Companion Diagnostics: Enabling Personalized Medicines in
Cancer
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