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Oct 16, 2012

FDA Clears Hologic’s HPV 16, 18/45 Genotype Assay

  • FDA approved Hologic’s Aptima HPV 16 18/45 Genotype Assay for use on the firm’s Tigris system. Hologic says the assay is the first cleared in the U.S. for genotyping human papilloma virus (HPV) types 16, 18, and/or 45, which are associated with about 80% of all invasive cervical cancers. Hologic acquired the test and the Tigris system through its $3.8 billion buyout of GenProbe, which it completed in August.

    The Aptima HPV 16 18/45 Genotype Assay has been cleared for two applications. Firstly, as an adjunct with the Aptima HPV assay in women over 30 years old in combination with cervical cytology to assess the presence of the high-risk genotypes 16, 18, and /or 45. Secondly, as an adjunct to testing with the Aptima HPV assay in women aged 21 years and over in whom cytology has identified atypical squamous cells of undetermined significance.  

    The Aptima HPV assay, also run on the Tigris system, was approved by FDA in October 2011 and CE marked in 2008. The test detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions. Both the Aptima assays are carried out on ThinPrep liquid cytology specimens.

    The Aptima product line includes assays for chlamydia/gonorrhea (CT/NG), human papillomavirus (HPV), and Trichomonas.

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