CAP-PAP TEST FOR SPECIMENS COLLECTED IN SOLUTION

The CAP-PAP test is a single-slide, double-staining, in vitro method for labeling dysplastic cervical cells on Pap smears (USPTO#6, 143, 512). A recently completed clinical laboratory trial (1R43CA86767-01) has shown that this test is easily applicable in a routine cytopathology laboratory for cervical cancer screening. The safety of the new method was equal, and its efficacy and prognostic value was superior to the control Pap test. We propose to study how the CAP-PAP test could be applied on thin and monolayers of cervical cells collected with any of the new liquid-based cervical specimen collection technologies. It is CAP-PAP test will help users of these technologies to improve the accuracy of cancer detection of the original CAP-PAP test procedure, will e considered for patient application. Recently, the business reports signaled that the FDA approved liquid- based specimen collection technologies have penetrated the Pap test market in the US up to 30%. This means that a modified CAP-PAP test could face a market of 10-30 million test per year. PROPOSED COMMERCIAL APPLICATIONS: If approved as an in vitro diagnostic medical device, this test will face a market of 10-30 million Pap tests per year (specimen collected using any of the liquid-based specimen collection technologies).