SBIR-STTR Award

BioSciCon is in possession of a patent application for a new method that could be developed into an in vitro diagnostic medical device for primary cervical cancer screening (CCC). This application is for a phase I/II clinical laboratory trial to study how the new test can increase sensitivity of cytotechnologists---- performing primary screening of Pap smears----to detect abnormal slides. The CAP-PAP test (CP) is a single-slide, double-staining method providing instant assessment of cervical acid phosphatase activity and Papanicolaou- based cell morphology on Pap smears. The method is based on visualization of acid phosphatase activity inside abnormal cervical epithelial cells counterstained by a modified Papanicolaou staining technique. The test is coming in a period when numerous companies are trying to improve Pap test. CP is designed for use on conventional Pap smears, but it could be upgraded to use smears from liquid-based collections of specimens. CP is designed for visual assessment but, without modification, CP stained smears could be used by any of computer-assisted image analysis technologies for primary and/or secondary CCC. Low cost of CP ($1.00 above the current reimbursement for Pap test) and standardized staining procedure (internal and external quality control, and HeLa cell line control standard smears) provide advantage over all current technologies used for CCC. PROPOSED COMMERCIAL APPLICATIONS: If approved as a diagnostic medical device,the test will face a market of 100 millions requests per year.

Thesaurus Terms:
acid phosphatase, cervical /vaginal smear, cervix neoplasm, cytodiagnosis, diagnosis design /evaluation, neoplasm /cancer diagnosis biomarker, clinical trial, clinical trial phase I, clinical trial phase II /III /IV, enzyme activity female, human subject

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.

Thesaurus Terms:
acid phosphatase, cervical /vaginal smear, cervix neoplasm, cytodiagnosis, diagnosis design /evaluation, neoplasm /cancer diagnosis biomarker, clinical trial phase II /III /IV, enzyme activity clinical research, female, human subject