Trial Information

Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the TIGRIS® DTS® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens

The APTIMA HPV 16 18/45 Genotype Assay (AHPV-GT Assay) is an in vitro nucleic acid
amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of
human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with
positive results in the APTIMA HPV Assay. The AHPV-GT Assay can differentiate between
samples positive for HPV 16 from those positive for HPV 18 and/or 45, but does not
differentiate between HPV 18-positive samples and HPV 45-positive samples. Cervical
specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic,
Inc., Marlborough, Massachusetts) with commercially available collection devices (broom-type
collection device or cytobrush/spatula combination) may be tested with the AHPV-GT Assay
either pre- or post-Pap processing. The assay is used with the TIGRIS DTS (TIGRIS) System.

In both the ASC-US Study and Adjunct Study populations, the objectives are to:

- evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical
disease in women with APTIMA HPV Assay positive results and

- evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45
in women with APTIMA HPV Assay positive results.