MarkPap™ Kit for cervical cancer screening

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

BioSciCon, Inc, Rockville, MD, United States

AIM: The MarkPap™ Test (formerly CAP-PAP Test) is a procedure for cervical cancer screening based on a novel biomarker of cervical dysplasia. In order to facilitate the performance of this test, we developed a prototype of a Kit. The BioSciCon’s MarkPap™ Research Kit is now manufactured by Ricca Chemical Company (Arlington, TX, USA). METHOD: The MarkPap™ Kit is an assembly of reagents, procedures and controls. It includes, for the first time in Pap test history, a cell line-based control slides made of HeLa cell line cells and buccal cells. We also tested this kit in an automated mode (ThermoShandon’s modified Varistain Gemini with Wet Heated Station). RESULTS: In a study, the Kit was applied on 600 specimens. The results showed that: (1) COMBO slides served as an excellent external quality control tool for adequacy of staining. (2) Using the Kit was less time consuming, the reagents were less expensive, the results more consistent, and the images were easier to screen and interpret. CONCLUSION: The MarkPap™ Kit successfully facilitated the performance of MarkPap™ Test, further reduced its already low cost, improved productivity and reduced liability. Global use of this technology for mass cervical cancer screening, including mid-income countries and developing countries is considered.

Paper presented at the International Symposium on Predictive Oncology and Intervention Strategies; Nice, France; February 7 - 10, 2004; in poster session 992 (Screening & detection).