Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System

Clinical Evaluation of the APTIMA® HPV 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 purpose of this study is to provide data on the performance of the APTIMA HPV Assay using the TIGRIS System in detecting HPV types that may cause cervical cancer.

The primary objective of the clinical trial is to evaluate the APTIMA HPV Assay, using the TIGRIS System, in cervical cancer screening programs. This will be achieved by determining the performance of the assay for detecting high-risk human papillomavirus (HPV) types in women with known cervical disease status. The assay will be evaluated in sample populations of women with ASC-US Pap test results ("ASC-US results") and women 30 years of age or older ("30+ years of age") with negative (NILM) cytology results.

Inclusion Criteria:

• Female 21 years or older (ASC-US study only)
• Female 30 years or older (Adjunct and ASC-US studies)
• Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit
• Ability to comprehend and sign an IRB-approved Informed Consent Form

Exclusion Criteria:

• Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months
• Abnormal Pap test result in the past 12 months
• Subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian
• Known to be pregnant
• Having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial
• Having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial
• Prior vaccination for HPV