Evaluation of Intrinsic Fluorescence for Detection of Disease

Detection of an HCV-specific spectral signal

Seroptix has evaluated its HR-INFLIT(355) system (formerly known as the ID-LBS) for the detection of a specific fluorescence signal associated with Hepatitis C virus (HCV) infection. Based on the results of sample preparation and spectral screening studies, the Company developed an optimized assay for the detection of a unique spectral signal present in the plasma of HCV infected patients. This assay and HR-INFLIT instrument have been tested with multiple plasma samples obtained from recently diagnosed HCV-positive individuals prior to the initiation of anti-viral therapy, and represents an important demonstration of the power of the SMI strategy and INFLIT systems. The specific assay format and preclinical results were presented at the 2001 meeting of the American Association of Blood Banks, and an abstract published in the October 2001 issue of Transfusion.

Seroptix considers the results of these efforts to support the aggressive expansion of the application of the SMI approach to other diseases, and also believes that direct detection assays based on intrinsic fluorescence patterns may have clinical and commercial value. The lack of immunological and gene-based reagents, significantly reduces the assay complexity, time-to-results, and overall cost of the assay to a level that may permit its use in many clinics, point-of-care or near-patient settings. At this time the Company is not planning to independently develop this system for clinical use, however, the Company will continue to evaluate and consider further development through funded partnerships with capable diagnostic development companies.

Seroptix management believes that direct detection of intrinsic fluorescence holds potential clinical and commercial value for the development of efficient sensitive assays for many diseases. Throughout the pursuit of its SMI initiatives and disease sample testing, the Company intends to continuously evaluate new opportunities to develop and implement assays based on its spectral discoveries.


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