Enhancing Pap test with a new biological marker of cellular dysplasia with MarkPap™ Test

N Markovic MD PhD, P Emer, O Markovic MD PhD Prof

BioSciCon, Inc, Rockville, MD, United States

AIM: Pursuant to a goal of finding simple and inexpensive approach to enhance the visibility of abnormal cells on Pap smears, and to reduce the false-negative rates, we investigated how the MarkPap™ Technology (test, kit and solution) meets this goal. This technology is formerly known as the Cervical Acid Phosphatase--Papanicolaou test (CAP-PAP Test, US Patent). METHOD: MarkPap™ Test is based on a new biological marker of cervical dysplasia, the Cervical Acid Phosphatase (CAP). This enzyme is visualized as red-colored deposit on Pap stained background, flagging abnormal cells and attracting the attention of a screener. Normal cells are entirely negative. RESULTS: In a clinical laboratory trial including 1,400 subjects/specimens, we found that MarkPap™ Test significantly decreased the false-negative proportion (from 9% to less than 4%), and doubled the true positives (ASCUS and above) in comparison with the conventional Pap test. CONCLUSION: More accurate, low cost and simple, the new test could be easily implemented in every cytopathology laboratory performing the Pap test.

Paper presented at the International Symposium on Predictive Oncology and Intervention Strategies; Nice, France; February 7 - 10, 2004; in oral session 893 (Molecular pathology - Part I).