The power of the biomarker for cervical cancer control

Abstract

11001 Background: At ASCO 2001, the Cervical Acid Phosphatase - Papanicolaou Test (CPT) was introduced as a biomarker-based technology as a potential in vitro diagnostic device. At ASCO 2004 and 2005, we reported results from clinical trials on 2,000 subject/specimens. In a setting of standard cervical cancer screening, the safety and effectiveness of CPT (MarkPap® Test) was compared with control Pap smear and LBP. The favorable results motivated us to expand this translational research in areas where this biomarker is crucial: self-sampling and digital evaluation. We report a pilot study designed to assess whether upgrading CPT with digital image processing (IT technology) could create a new device for an effective telecytopathology. Methods: Material: Cervical specimens self-obtained by volunteers, specimens collected in prior clinical trials (Library of MarkPap slides), and control slides. Instruments and methods: We have assembled a set of instruments and procedures to create images from microscopic slides, to convert analog into digital images, to capture and store digital images and clinical data in computer files, to transfer image files via Internet to a central server for evaluation by cytotechnologist/pathologists, and to return the reports within hours. At the end, the results of reading digital and direct images were available for comparison. Results: Since each instrument was “fit-for-use”, we have tested different “conditions-for-use” for providing digital images comparable to direct images. Images of self-sampled specimens, controls and existing slides were processed through a new setup of five modules: image acquisition, image and data transferring, image evaluation, results reporting and quality control. It was made possible by upgrading software. There was no difference between results obtained after evaluation of digital or direct images. Conclusion: Using CPT and available instruments and software, we have developed a prototype in vitro diagnostic medical device, which could permit expert evaluation of cervical specimens to be performed rapidly and at affordable cost for developing countries. This device should be able to use self-obtained specimens, field laboratory personnel and equipment, but to provide high-qualified evaluation within hours for an easy affordable cost. [Table: see text]