practice both of diagnostic and therapeutic medicine today generally
is focused on detecting and in some cases measuring the presence
of a disease 'marker,' and then employing a therapeutic to modulate
a 'target' involved in the biological pathology of the disease.
In some but not all cases the diagnostic marker and the therapeutic
target are the same. The current portfolio of diagnostics and
drugs is directed at approximately five hundred disease targets
only. Subsequently, many diseases cannot be diagnosed or treated
with as high a degree of success - the goal being one hundred
percent success - as everyone would like. Some diseases are detected
and treated better than others, but in the majority of diseases,
including infectious disease, cancers, heart disease, and neurological
disorders, there is a need for improved detection and treatment
Many pharmaceutical and biotechnology companies are attempting
to apply 'genomic' and 'proteomic' strategies to isolate novel,
proprietary molecular markers of disease, and in turn develop
proprietary diagnostics and therapeutics. A major reason for this
push is that the proprietary nature of novel targets yields a
de facto monopoly with regard to diagnostics and therapeutics
acting on that target. Many technical issues remain to be resolved,
however, before these functional genomics and proteomics companies
will be able to benefit from their research investment, and produce
validated disease targets. Many analysts predict it will take
decades to realize fully the value of genomics and proteomics,
thus leaving in place an immediate market opportunity for a pioneer
of novel markers of disease.
will identify new disease markers expeditiously through the use
of a methodology referred to as Spectra-Molecular Informatics
(SMI). SMI, which is focussed on the evaluation of the profile
of small molecules associated with disease, may be considered
as a 'metabolomic' or 'chemical genomic' approach. The SMI strategy
combines spectroscopy, biochemistry, and informatics to expedite
the development of novel diagnostic assays and to isolate and
validate proprietary molecular markers of disease.
addition to genes and proteins, there exist many categories of
biological molecules, including carbohydrates and small organic
molecules that hold major physiological significance. The variations
in these molecules represent the complex interaction of the organism's
genome and proteome with environmental factors that include diseases.
Alterations in a subject's profile may have linkage to an acute
disease or correlations with disease progression.
a definitive relationship between the profile of small organic
molecules and specific diseases provides another pathway for building
new approaches to early diagnosis and treatment of infectious,
cancerous, and metabolic diseases. Perhaps of greatest importance
is the potential power of this approach for the prospective detection
of indicators of 'subclinical' disease in healthy individuals
and development of individualized disease prevention strategies.
The analysis of these non-genetic molecules seeks to correlate
the effects of the broadest range of environmental influences
(i.e., infectious agents, diet, exposure to toxins) on the complete
portfolio of biological molecules found in an organism over time.
the key to its SMI strategy, SerOptix has identified the subset
of small organic molecules that are naturally fluorescent (intrinsically
fluorescent) as sensitive primary markers of disease and targets
for new product development. These 'fluorogenic' molecules represent
structurally diverse molecular families with widely divergent
biologic roles. The portfolio of intrinsically fluorescent molecules
that a host possesses therefore represents a broad view of the
physiological status of the organism, and aberrations of many
biochemical pathways will ultimately lead to a disruption of the
normal physiologic level of one or more of these natural fluorescers.
As markers of disease state, these intrinsically fluorescent molecules
hold great value as vehicles both to screen for disease directly
and for diagnostic and therapeutic development.