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HPV vaccine approval

This article was originally published in The Gray Sheet

Executive Summary

Introduction of Merck's human papillomavirus vaccine Gardasil will not change the need for Pap or HPV screening, says Digene, which manufacturers the only diagnostic approved by FDA as an adjunct to the Pap test for primary cervical cancer screening. The vaccine is "not a magic bullet for eliminating cervical cancer," Digene says, because it does not protect against all strains of HPV and it is not appropriate for all populations of women. FDA approved the vaccine June 8 for use in girls and women ages 9 to 26. Digene hopes to leverage Merck's vaccine promotions to boost sales of its hc2 High-Risk HPV DNA Test (1"The Gray Sheet" May 15, 2006, p. 12)...
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