4.
Validation of Molecular Target as Disease Marker
Depending
on the level of technical feasibility and quality of commercial
opportunity presented, we expect to broaden our technology base
to include extensions of molecular characterization and validation.
We envision focusing on molecular characterization, cellular testing
and preclinical evaluation; but will not initiate human clinical
trials which will be the responsibility of corporate partners.
Further validation of the role of the identified molecular species
as a disease response or cause will be implemented on a case-by-case
basis, depending on the level of discriminatory power, novelty
of the molecule identified, and corporate strategic issues. SerOptix
will invest further direct resources in programs where limited
validation research can be conducted that will significantly raise
the value of the intellectual property portfolio surrounding the
target molecule.
One
approach to target validation that will be routinely applied will
include the development of a prototype validation assay to permit
the demonstration of feasibility of a specific molecule-directed
test system as well as the confirmation of the level of the subject
molecule in a broad field of patient samples. For most targets,
SerOptix will develop validation assays that rely on fluorescent
signals for molecule detection. This approach will best utilize
SerOptix' existing scientific expertise and instrumentation, and
may permit the possible future development of a portfolio of marketable
or licensable assays that utilize common spectral parameters for
detection of different molecules.
A
primary application of the prototype assay will be the validation
of the true association of the molecular target with the selected
disease. Fresh (and archived) patient and normal samples will
be surveyed quantitatively for the content of the subject molecule.
Statistical confirmation of the disease association and quantitative
relationship with other disease parameters will provide valuable
information concerning the appropriate medical applications of
the target molecule for potential therapeutic strategies and diagnostic
assays.
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