Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System
 in cervical cancer screening.

 This objective will be accomplished in the ASC-US Study by evaluating the performance
 characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women
 with ASC-US Pap test results who were 21 years of age or older ("≥21 years of age") at the
 time of their Pap visit. For the Adjunct Study, this objective will be accomplished by
 evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at
 increased risk of cervical disease in a sample population of women with negative
 (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.
Inclusion Criteria:

 Subjects who were previously enrolled into the prospective, multicenter US clinical study
 for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible
 for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this
 protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for
 inclusion.

 Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following
 criteria are met:

 -  the subject attended the colposcopy visit, or

 -  the subject did not attend the colposcopy visit but the referral Pap sample had a
 positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol
 2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol
 AHPVPS-US11-003).

 Exclusion Criteria:

 Eligible subjects will be excluded if they do not have an evaluable sample. This may be due
 to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored
 under unacceptable conditions).