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AutoCyte Automated Pap Smear Sample PREP System To Ship By July 1

This article was originally published in The Gray Sheet

Executive Summary

Shipments of AutoCyte's PREP automated, liquid-based Pap smear cytology sample preparation system are expected to begin by July 1, following FDA approval June 17 as a replacement for the conventional method of Pap smear preparation in primary screening for cervical cancer.

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Cytyc Cites FDA Warning Letter In Second Infringement Action Against TriPath

TriPath's marketing claim that its AutoCyte PREP has results superior and not similar to conventional Pap smear testing "is particularly egregious because it attempts to mislead and confuse consumers about the efficacy and identity of the two products," competitor Cytyc, Inc. claims in a suit filed May 12 in Boston federal court.

Cytyc Cites FDA Warning Letter In Second Infringement Action Against TriPath

TriPath's marketing claim that its AutoCyte PREP has results superior and not similar to conventional Pap smear testing "is particularly egregious because it attempts to mislead and confuse consumers about the efficacy and identity of the two products," competitor Cytyc, Inc. claims in a suit filed May 12 in Boston federal court.

TriPath "Direct To Vial" AutoCyte Prep Use Must Be Reviewed By FDA

FDA will need to approve data comparing "direct to vial" use of TriPath Imaging's AutoCyte PREP system to historical performance using traditional Pap smear before the company can use the information to market the system, according to a recent agency warning letter.

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