" The process of screening and interpreting a manually prepared Pap smear is complex and tedious. This process requires constant vigilance, as approximately 90% to 95% of all Pap smear diagnoses in the United States are negative. In addition, the process is prone to error as a result of the complexity of properly evaluating and categorizing subtle and minute changes in cellular or nuclear detail. The screening process requires intense visual review through a microscope of a large volume of slides, each of which
typically contains 50,000 to 300,000 cervical cells. The small percentage of Pap smears that contain any abnormality may, in turn, contain only a small number of abnormal cells among the vast number of normal cells. Cytotechnologists generally review each slide for approximately five to 10 minutes and may review up to 100 slides per day. All of these factors contribute to the incidence of false negative diagnoses."
"The ThinPrep 2000 Processor allows for the processing of approximately 20 to 25 patient samples per hour."
" On November 8, 1996, the Company and Neopath, Inc. ("Neopath")
announced the completion of a joint study of the feasibility of screening cervical specimens using the ThinPrep System in conjunction with Neopath's AutoPap QC. "
"In the United States, the current rate of reimbursement to laboratories from managed care organizations and other third-party payors to screen conventional Pap smears ranges from $6.00 to $36.00 per test, with $17.00 as the most common rate of reimbursement. The Company believes that the cost per ThinPrep Pap Test, plus a laboratory mark-up, will be billed to third-party payors and
result in a higher cost than the current charge for conventional Pap tests."
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