Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System

Status:	Not yet recruiting
Conditions:	Infectious Disease, Women's Studies, Dermatology
Therapuetic Areas:	Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Reproductive
Healthy:	No
Age Range:	Any
Updated:	11/11/2012
Start Date:	October 2012
Contact:	Philip Estes
Email:	philip.estes@hologic.com
Phone:	858-731-5842

Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® 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 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).

We found this trial at

sites

Laboratory Corporation of America

Burlington, North Carolina 27215

from

Burlington, NC