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.
If approved as a diagnostic medical device,the test will face a market of 100 millions requests per year.
| Markovic, O; Markovic, N (2003) Cervical acid phosphatase: a biomarker of cervical dysplasia and a potential surrogate endpoint for colposcopy. Dis Markers 19:279-86 |
