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Digene Rapid Capture

This article was originally published in The Gray Sheet

Executive Summary

High-volume sample throughput instrument gains PMA supplement approval for use with the firm's HC2 HPV DNA test, also marketed as DNAwithPap for primary human papillomavirus screening in conjunction with Pap smear. The system incorporates automated pipetting and microplate processing to analyze 352 patient samples in a 6.5-hour lab shift, and is expected to facilitate DNAwithPap adoption by large labs, Digene says (1"The Gray Sheet" Nov. 10, 2003, In Brief). Rapid Capture previously was cleared for use with Digene chlamydia and gonorrhea tests. HPV sales drove Digene revenue up 39% to $23.6 mil. for its fiscal third quarter (ended March 31)...
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