NCT01694875

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 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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Gen-Probe, Incorporated · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Human Papillomavirus Infection

Interventions

Type	Name	Description
DEVICE	APTIMA HPV Assay	In Vitro Diagnostics Assay

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-09-27
• Last updated: 2012-11-14

Locations

3 sites across 1 country: United States