CAP-PAP TEST FOR CERVICAL CANCER SCREENING 2

DESCRIPTION (provided by applicant): CAP-PAP Test (further: CPT) is a double-staining, single-slide method for cervical cancer primary screening based on a new biological marker of cervical dysplasia (US patent No. 6,143,512 of November 7, 2000). In phase-1 study (SBIR-NCI-NIH award No. 1R43CA86767-01) the method was established as a research service in a cytopathology laboratory (infrastructure: space, equipment, personnel trained for marker processing, staining and interpretation). A clinical laboratory trial (BSC-9902) began to study the accuracy of CPT in comparison with Pap test (adjudicated cytology standard) in a low-risk population of women recruited at clinical sites. After 200 analyses, in comparison with a historical control (Pap test), CPR was shown to increase perception of cytotechnicians performing primary screening and that this increased ability can result in a reduction of false negatives and an increase of true positives (ASCUS and above). After the method feasibility is confirmed, we are proposing this phase-2 project "CAP-PAP Test for Cervical Cancer Screening" to study, on 1,800 healthy women (three clinical sites), the efficacy of CPT in comparison with Pap test (clinical outcome standard) to predict occurrence and/or progress of cervical cancer or precancerosis. The goal is to bring to public benefit a screening test that could improve accuracy of Pap test, save many lives and reduce the cost of healthcare. Successful completion of phase-2 study will warrant entering a commercialization in phase-3, The test is lowcost (approximately $1.00 above the current cost of Pap test), consumer friendly (one day training), and accurate (internal control) The new marker is complementary (not competitive) to other technologies that have been recently developed to improve technical weaknesses of the conventional Pap test. If successful, CPT could face a market of 80 million requests per year. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE