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

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 duringthe 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 oftheir parent or legal guardian

• Known to be pregnant

• Having an illness or medical condition that could interfere with or affect theconduct, results, and/or completion of the clinical trial

• Having an illness or medical condition that the investigator or physician feels wouldcreate an unacceptable risk to the subject if she enrolled into the clinical trial

• Prior vaccination for HPV