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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Completed
Application Number P120007 / PAS001
Date Current Protocol Accepted 10/12/2012
Study Name HPVGTS-US-10-002
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled 10,545
Actual Number of Sites Enrolled 13
Patient Follow-up Rate 96.76%
Final Safety Findings No issues concerning the safety of the APTIMA HPV GT Assay on either TIGRIS or PANTHER platform were reported by the sponsor or identified by the reviewer.

Final Effect Findings The absolute risk of cervical disease is greater in subjects with positive APTIMA HPV GT Assay results than in subjects with negative APTIMA HPV GT Assay results.
Study Strengths & Weaknesses This study was able to demonstrate that the APTIMA HPV GT assay¿s postmarket performance is characterized by relatively high sensitivity and specificity, especially for identifying women who have higher risk of developing high-grade and invasive cervical cancer.

However, this study had a limited ability to stratify women with low-grade lesions. In addition, the study

did not address the relevance of HPV positivity in the absence of cytological abnormalities which would require de novo data collection with a longer follow-up

Recommendations for Labeling Changes Yes

HPVGTS-US-10-002 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/12/2013 04/11/2013 On Time
one year report 10/12/2013 10/10/2013 On Time
18 month report-Final 04/26/2014 04/28/2014 Overdue/Received

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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