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Recent evidence suggests some of the DNA released from tumor cells undergoing apoptosis ends up in the serum of patients. Measurements of the levels of this DNA are beginning to be used to follow patients during their course of therapy as a potential surrogate measure of response. Most of these measurements involve a relatively insensitive ELISA-based method to capture and quantify nucleosomal DNA in the serum. Pathogenesys has recently discovered and verified the performance of a sensitive fluorescence-based test to measure “masked” DNA in serum. This assay correlates well with ELISA-based assays but has superior sensitivity, reproducibility, and throughput. To date, serum from 40 normal individuals have all demonstrated relatively low levels of masked DNA and serum from 20 individuals with breast carcinoma have all had relatively high levels of masked DNA. A small sample of these are shown in the graph below. Additional human and animal model studies are underway to further characterize the utility of this measurement as a surrogate marker for drug response. A paper is currently being submitted for peer review that describes these findings. Any interested group that wants to get involved in the clinical validation of this potentially useful assay is encouraged to contact Dr. James Thompson at 949-258-0318 or jthompson@pathogenesys.com . If found useful as a surrogate marker of response to a variety of drugs and because this assay can be potentially applied to all tumor types, the market for a commercial test could be enormous.
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