88
current research awards for future projects are to validate and refi ne established
technologies including those to detect genetic changes in live animals, detect the
slightest differences in genetic variation, and profi le gene expression in a cell’s
nucleus to identify early protein signatures. Examples are gene expression sensors
that detect environmentally triggered changes among cells in living tissue and tech-
nologies that uncover how a gene regulator exerts effects on different classes of
target genes.
A wide variety of drugs in late preclinical and early clinical development are
being targeted to disease-specifi c gene and protein defects that will require co-
approval of diagnostic and therapeutic products by regulatory agencies. An increas-
ingly educated public will demand more information about their predisposition for
serious diseases and how these potential illnesses can be detected in an early stage
when they can be arrested or cured with new therapies custom-designed for their
individual clinical status. To respond to this demand, major pharmaceutical compa-
nies will partner with diagnostics companies or develop their own in-house capa-
bilities that will permit effi cient production of more effective and less toxic
integrated personalized medicine drug and test products. For clinical laboratories
and pathologists, this integration of diagnostics and therapeutics represents a major
new opportunity to emerge as leaders of the new medicine, guiding the selection,
dosage, route of administration, and multidrug combinations and producing
increased effi cacy and reduced toxicity of pharmaceutical products.
Advances in new technologies such as nanobiotechnology have not only refi ned
molecular diagnosis but facilitated its integration with targeted drug delivery
for development for personalized medicine. Role of nanobiotechnology is described
in Chap. 7.
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2 Molecular Diagnostics in Personalized Medicine