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Diagnostic Technologies and Molecular and Cellular Profiling: Biomarker Assay Development, Validation, and Qualification

HAAH is a serum biomarker for prostate cancer

Panacea Pharmaceuticals, Inc., Gaithersburg, MD

Abstract

A9

Prostate-specific antigen (PSA) is well established as a molecular marker of prostate cancer (PC). Current recommendations suggest annual PSA testing in all men over 50 years of age; initial PSA testing in men at high risk for PC is recommended starting at 40 years of age. While highly sensitive for the detection of PC (95%) total serum PSA lacks specificity (20%) resulting in large numbers of false positives and unnecessary biopsies. This low specificity can be attributed to the fact that PSA is found in both normal and tumor tissue, and can be up-regulated in benign conditions of the prostate. To date measurement of the percentage of free PSA, complexed PSA and PSA velocity have resulted in minimal (<5%) improvements in specificity. Thus, the identification and acceptance of a simple test to detect prostate cancer that exhibits higher specificity and similar sensitivity compared to PSA could have the potential of reducing biopsies performed due to false positive screening results and improve the quality of medical care. We have investigated the utility of human aspartyl (asparaginyl) ß-hydroxylase (HAAH) as a cancer molecular marker. HAAH has been detected by immunohistochemical staining (IHC) in a broad range of cancers including PC. It is highly specific having been detected by IHC in >99% of tumor specimens tested (n>1000) while absent in adjacent non-affected tissue, or in tissue samples from non-affected individuals. We have previously identified the presence of HAAH at detectable levels in the sera of cancer patients and have developed a sandwich ELISA for its detection. Preliminary results demonstrated a specificity of 97% (n=230) and a sensitivity of 94% (n=85) for a series of cancers including breast, ovarian, colon, esophageal, bladder and kidney. Here we have utilized this assay to detect HAAH levels in the sera of patients diagnosed with PC compared to non-affected individuals. HAAH was detected above a threshold level of 11 ng/ml in 100% of the sera of PC patients (n=16); PC status was confirmed by biopsy. All non-affected individuals (n=23) had HAAH values below the threshold. Further studies including a direct comparison of HAAH to PSA levels are underway. These data suggest that measurement of serum HAAH levels may enhance and potentially supplant PSA testing for the early detection of PC, and potentially reduce the number of prostate biopsies performed due to false positive screening results.