NeoPath
This article was originally published in The Gray Sheet
Executive Summary
Files a registration statement with the Securities and Exchange Commission for an initial public offering of 3 mil. shares. NeoPath is developing AutoPap automated Pap smear screening systems, which it intends to market to clinical laboratories. Its first product is expected to be the AutoPap QC, intended for use as a quality control mechanism for the detection of false negatives from Pap smears already examined by a cytotechnologist. NeoPath says it anticipates submitting a premarket approval application to FDA in 1995 for the QC, which currently is in clinical trials at six U.S. sites. Clinicals for the AutoPap Screener are slated to begin in 1995. The Screener, according to NeoPath, "is designed to be introduced into the clinical laboratory workflow prior to Pap smear screening by a cytotechnologist" and can eliminate those pap smears which need no further review by a cytotechnologist. Once the Screener reaches market, Neopath plans to cease production of the QC.
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