EARLY DIAGNOSIS OF CANCER: HAAH-BASED SERUM IMMUNOASSAY

Background: Human Aspartyl (asparaginyl) β-hydroxylase (HAAH) is an enzyme expressedprenatally and re-expressed in cancer cells but not in normal cells. Its function is consistentwith cancer etiology: growth, motility and invasion of the cancer cells. HAAH is atransmembrane protein and is readily shed in blood of cancer patients. It is a cancer specificbiomarker. The specificity of the biomarker was confirmed using immunohistochemistry(n=71,000), gene expression analysis (n=74,000), in vivo binding (n=7) and immunoassays(n=7).Objectives: To introduce HAAH as a cancer specific biomarker and present a test for earlydiagnosis of cancer.Methods: Panacea Global’s cancer diagnostic tests measure the level of HAAH in serum byenzyme linked immunosorbant assay or ELISA. The method is CLIA certified in the UnitedStates and the analyte specific reagents are manufactured under GMP specifications.Results: In a blinded clinical study involving lung cancer, breast cancer, prostate cancer andcolon cancer, as well as non-cancer patients for a total of 857 patients’ serum specimens, thefollowing results were obtained: sensitivity, 94.7% (n=857); and specificity, 94.3% (n=211).The overall accuracy was 94.6%. The means were 25.7 ng/ml, 34.6 ng/ml, 17.6 ng/ml, and30.0 ng/ml for prostate cancer, lung cancer, breast cancer, and colon cancer specimensrespectively. The mean for non-cancer was 0 ng/ml. The cancer patients were positivelydiagnosed as such by standard method of care (including biopsy) and were in various stagesof cancer. For the prostate cancer group, the HAAH level did not correlate with PSA asexpected. The test had comparable accuracy for Stage 1 lung cancer which is difficult todiagnose.Conclusion: The relevance of HAAH to cancer makes this diagnostic test useful for themanagement of patients by physicians. The test has excellent accuracy under ideal conditionsand expected to perform well under routine patient management situations. The test can beused for initial diagnosis, patient monitoring post-treatment, and sensitivity to certain anticancerdrugs.

EARLY DIAGNOSIS OF CANCER: HAAH-BASED SERUM IMMUNOASSAY Keywords:

Cancer , Cancer Biomarker , Early Diagnosis , ELISA , HAAH-based