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This article was originally published in The Gray Sheet

Executive Summary

TriPath will resubmit its withdrawn PMA supplement application to FDA "at the earliest possible date" for use of SurePath liquid-based Pap test specimen-collection medium samples with Digene's Hybrid Capture 2 (HC2) high-risk human papillomavirus (HPV) DNA test, the firm says. The withdrawal of the August 2004 application follows discussions with FDA that revealed "additional clinical information and analyses would be required," TriPath explains (1"The Gray Sheet" Aug. 30, 2004, In Brief). A Digene PMA supplement for the combination was rejected by FDA in 2002. TriPath reports it achieved profitability for the first time in 2004, earning $605,000 on sales of $68.5 mil., up 27%...

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