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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