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FDA Approves Two Hologic HPV Tests
Date:3/13/2009

Cervista HPV HR: First FDA approved high-risk HPV test in a decade

Cervista HPV 16/18: First HPV DNA genotyping test approved by the FDA

BEDFORD, Mass., March 13 /PRNewswire-FirstCall/ -- Hologic, Inc., (Hologic or the Company) (Nasdaq: HOLX), a leading women's healthcare company dedicated to serving the healthcare needs of women, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's premarket approval (PMA) applications for both the Cervista(TM) HPV HR (high risk) and the Cervista HPV 16/18 tests. Cervista HPV HR, designed to detect the 14 high-risk types of human papillomavirus (HPV) known to cause cervical cancer, is the first HPV DNA test approved by the FDA in more than 10 years. Cervista HPV 16/18 is the first HPV test approved for genotyping for HPV types 16 and 18, known to be associated with approximately 70% of all cervical cancers in the United States.

The Cervista HPV HR test has been approved for two uses:

  • To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.

  • Used adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.

The Cervista HPV 16/18 test has been approved for two uses:

  • In women 30 years and older the test may be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types.

  • Used adjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytol
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SOURCE Hologic, Inc.
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