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.