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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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Application Number P100042 / PAS001
Current Plan Approved 10/28/2011
Study Name APTIMA HPV Assay
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
Final Study Results
Number of Patients 10,545
Number of Sites 13
Follow-up Rate 96.76%
Safety Findings No issues concerning the safety of the APTIMA HPV Assay on either TIGRIS or PANTHER platform were reported by the sponsor or identified by the reviewer.

Effect Findings The absolute risk of cervical disease is greater in subjects with positive APTIMA HPV Assay results than in subjects with negative APTIMA HPV Assay results.
Strengths & Weaknesses This study was able to demonstrate that the APTIMA HPV 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 the 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.
Label Changes Yes

APTIMA HPV Assay Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 04/27/2012 04/26/2012 On Time
one year report 10/27/2012 10/16/2012 On Time
18 month report 04/27/2013 04/11/2013 On Time
two year report 10/27/2013 10/10/2013 On Time
three year report-FINAL REPORT 10/27/2014 05/01/2014 On Time

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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