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Denise J. Herich
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Hill & Knowlton, for Correlogic Systems, Inc.
202-944-3367
denise.herich@hillandknowlton.com

JNCI STUDY REPORTS SUCCESSFUL USE OF PROTEOMICS AND BIOINFORMATICS TEST FOR DETECTION OF PROSTATE CANCER

Correlogic Systems, Inc., FDA, and NCI Study Further Confirms Validity of Same Technology Used in Early Detection of Ovarian Cancer

BETHESDA, MD, October 16, 2002 — A study published today in the Journal of the National Cancer Institute (JNCI) extends a breakthrough method of disease detection to prostate cancer. Researchers successfully applied pattern discovery technology to detect patterns of proteins rather than individual biomarkers for prostate cancer. The research provides further validation that the protein pattern approach is effective in cancer and other disease detection.

In the study, researchers used the approach and technology employed in a recently reported ovarian cancer test to successfully detect 95 percent of prostate cancer cases from a single drop of blood from each patient. Most significantly, researchers were able to rule out prostate cancer for 71 percent of men with intermediate PSA scores (4-10), which would have allowed them to avoid an unnecessary, invasive biopsy procedure. Currently, most men with PSA scores between 4 and 10 are recommended for a biopsy, even though 75 to 80 percent of them do not have prostate cancer.

"This new technology has the potential to revolutionize how men are diagnosed with prostate cancer," said David Ornstein, a co-author of the study and Assistant Professor of Urology at the University of North Carolina, Chapel Hill. "It is likely that it will be possible to use a simple blood test, to accurately identify men who are affected with a harmful prostate cancer but spare healthy men from undergoing unnecessary biopsies."

The study was conducted by researchers from the Food and Drug Administration (FDA)/ National Cancer Institute (NCI) Clinical Proteomics Program, the University of North Carolina Lineberger Comprehensive Cancer Center, and Correlogic Systems, Inc. Correlogic Systems, Inc. is both the co-inventor of the concept of uncovering hidden patterns of proteins and the sole developer of the proprietary algorithms and processes that identified the protein patterns in the study.

Using Proteome Quest^®, Correlogic's proprietary technology for identifying hidden patterns, researchers first examined blood samples of 31 men with known prostate cancer and 25 men without disease. From more than 15,000 data points per patient, Proteome Quest^® identified a proteomic pattern that discriminated the cancer from non-cancer samples. Then, researchers used this pattern - a computational disease "model" — to classify an independent set of 266 blinded patient blood samples. The model correctly identified 36 out of 38 cases as prostate cancer.

"These results mark a dual milestone in early cancer detection," said Peter J. Levine, President of Correlogic Systems, Inc. and a co-author of the JNCI paper. "In addition to the obvious implications for prostate cancer, these results provide significant confirmation of the premise of our approach — first reported in our ovarian cancer research earlier this year — that the presence of cancer can be revealed through hidden protein patterns. This is truly the beginning of a revolution in early disease detection."

Prostate cancer is the most common non-skin cancer and the second leading cause of cancer deaths in American men. Current detection methods include a prostate-specific antigen (PSA) test and digital rectal exam (DRE). Together, these methods are used to determine the need for an invasive prostate biopsy. Multiple approaches to improve the accuracy of the PSA test have been studied but none have been very successful.