Abstract
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.
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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.
Companies Mentioned in This Spectrum Report
- Abbott Diagnostics
- Affymetrix
- Alnylam Pharmaceuticals
- Applera
- Applied Biosystems
- Benitec
- BioForce Nanosciences
- Biosite
- Celera
- Cepheid
- Cetus
- Chiron
- deCode
- Epigenomics AD
- Genaco Biomedical Products
- Genzyme
- Illumina
- International Therapeutics
- Johns Hopkins University
- School of Medicine
- Johnson & Johnson
- MetriGenix
- Nanogen
- Nanolink
- Oncomethylome Sciences
- Orion Genomics
- Osmetech
- PamGene
- Qiagen
- Randox
- Roche Diagnostics
- Siemens Medical Solutions
- Group
- Tepnel (formerly Orchid
- Biosciences)
- Third Wave Technologies
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