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Mar 13, 2009

Hologic Obtains FDA Nod for Two HPV Tests

  • FDA approved Hologic’s Cervista™ HPV HR (high risk) and the Cervista HPV 16/18 tests. Cervista HPV HR is designed to detect the 14 high-risk types of the virus known to cause cervical cancer. Cervista HPV 16/18 is reportedly the first HPV test sanctioned for genotyping 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 may be used to screen patients with atypical squamous cells of undetermined significance as well as adjunctively with cervical cytology to screen women 30 years and older.

    The Cervista HPV 16/18 test may be used adjunctively with the Cervista HPV HR test and cervical cytology in women 30 years and older. It may also be used adjunctively with the Cervista HPV HR test in patients with ASC-US cervical cytology results, to assess the presence or absence of specific high-risk HPV types. 

    Cervista HPV HR includes an internal control intended to verify adequate cellularity for testing, thus reducing the potential for false negative results, according to Hologic. In addition, because it requires a smaller specimen volume, this technology may minimize inconclusive results.

    The Cervista HPV HR clinical trials enrolled approximately 4,000 women nationwide. The trial met or exceeded all target endpoints, according to Hologic. Most importantly, the Cervista HPV HR test achieved 100% sensitivity for the detection of CIN3, an immediate precursor to cervical cancer.



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