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In Brief: Neopath's Autopap

This article was originally published in The Gray Sheet

Executive Summary

Neopath's Autopap: Pap smear analysis product as a primary screening device will be reviewed by FDA's Hematology and Pathology Devices Panel on Jan. 28, the company reports. The PMA supplement would allow use of the Autopap to identify certain slides as not requiring a manual evaluation. Following the advisory panel's initial rejection of the supplement in September 1996, Neopath amended the application in August with prospective data from about 31,500 slides. The data show the system to be statistically "superior" to current practice in identifying a range of atypical Pap smears, according to the company. The Autopap currently is approved as a quality control rescreener of slides identified by technicians as negative...
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