The 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 methodologies.

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.

SerOptix 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.

In 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.

Establishing 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.

As 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.


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