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

This article was originally published in The Gray Sheet

Executive Summary

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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A $40 mil. investment in TriPath Imaging by pharmaceutical and diagnostics giant Roche was the driving force behind a 36.1% jump in TriPath's stock price in August. The issue gained 2-3/16 to close the month at 8-1/4.

TriPath Investment By Roche Boosts Stock 36% In August, Index Jumps 11%

A $40 mil. investment in TriPath Imaging by pharmaceutical and diagnostics giant Roche was the driving force behind a 36.1% jump in TriPath's stock price in August. The issue gained 2-3/16 to close the month at 8-1/4.

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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.

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