TriPath Imaging's PREPmate
This article was originally published in The Gray Sheet
Executive Summary
Accessory to AutoCyte PREP gains FDA approval, firm announces May 31. PREPmate system aids in preparing thin-layer slides by automatically mixing and removing specimen from CytoRich preservative fluid vials and layering it on a slide. FDA had previously said it would not approve the PMA supplement, filed in October 1999, until it investigated assertions made by a former employee questioning the use of AutoPap to screen thin-layer preparations (1"The Gray Sheet" April 9, 2001, In Brief)
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TriPath PREPmate Approval Lifts Stock 60%; OTC Index Outperforms Nasdaq
FDA approval of TriPath Imaging's PREPmate automated accessory for the AutoCyte PREP thin-layer sample preparation system combined with strong first-quarter earnings helped boost the company's stock price 60% in May. The issue advanced 3.27 points to close the month at 8.77.
TriPath PREPmate Approval Lifts Stock 60%; OTC Index Outperforms Nasdaq
FDA approval of TriPath Imaging's PREPmate automated accessory for the AutoCyte PREP thin-layer sample preparation system combined with strong first-quarter earnings helped boost the company's stock price 60% in May. The issue advanced 3.27 points to close the month at 8.77.
TriPath Imaging
FDA will not approve firm's PMA supplement to allow screening of AutoCyte PREP thin-layer preparation slides on the AutoPap system until it has fully investigated assertions made by a former employee questioning the use of the AutoPap to screen thin-layer preparations, firm announces April 2. An internal investigation has determined the assertions to be false, company manitains. Supplement was originally filed in October 1999. Additional data from a prospective, masked trial was submitted to FDA in December. TriPath may accept limitations in proposed product labeling to secure faster approval of the supplement, or choose to "collect additional data to support the current labeling proposal"