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| |  AutoPap Primary Screening System Approved by FDA REDMOND, WA -- May 5, 1998 -- The United States Food and Drug Administration has approved NeoPath, Inc.’s AutoPap® System for use as a primary Pap smear screener. The AutoPap Primary Screening System is the world's first device to receive FDA approval for use in automated initial Pap smear screening for the early detection of cervical cancer. Data from a large-scale, prospective, intended use clinical study comprised of more than 25,000 patient slides from five clinical laboratories showed that overall the AutoPap achieves greater accuracy in early diagnosis of cervical disease and reduces both false negative and false positive test results. The AutoPap Primary Screening System demonstrates a statistically significant increase in identifying disease when compared to current practice. Accuracy was significantly better than current practice in all measured disease categories: The AutoPap System utilises proprietary technology, including two unique slide classification algorithms to identify those Pap smears with the highest likelihood of abnormality. As an initial screener, the AutoPap Primary Screening System identifies up to 25 percent of slides that receive AutoPap review only and may be archived as normal. The remaining 75 percent of the slides have the highest probability of containing abnormal cells. Assisted by the AutoPap's slide ranking report, these remaining slides are screened by cytotechnologists. By reducing the number of Pap smears requiring human review, clinical laboratories have the potential to reduce their manual screening costs and at the same time, increase their screening capacity. Furthermore, increasing reimbursement rates for the Pap smear test may motivate laboratories to adopt the AutoPap Primary Screening System to expand their business.
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