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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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MWP-HPV-159


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General
Study Status Completed
Application Number /
Requirement Number		 P100020 / PAS001
Date Original Protocol Accepted 04/19/2011
Date Current Protocol Accepted 04/19/2011
Study Name MWP-HPV-159
Device Name COBAS HPV TEST
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 4,291
Actual Number of Sites Enrolled 61
Patient Follow-up Rate Above 80%
Final Safety Findings No severe adverse events were reported
Final Effect Findings A negative HPV result predicted a lower 3-year risk of ¡ÝCIN3 than did a negative cytology result.
The low 3-year (cumulative incidence ratio) CIR for a negative HPV result also confirmed the safety of a
3-year interval for HPV primary screening. The follow-up study confirmed the continued high risk of
HPV16 or HPV18 infection, with the observation that 1 in 4 women who tested HPV 16+ at Baseline and
1 in 9 who tested HPV18+ at Baseline were diagnosed with ¡ÝCIN3 within 3 years.
The follow-up data for the NILM population ¡Ý30 years demostrated safety over 3 years
of a negative HPV test at Baseline in the context of adjunct testing. In addition, the data demonstrated a higher risk associated with HPV16+ or HPV18+ results (9.56%).
Study Strengths & Weaknesses Strengths: Large sample size, high compliance at all follow up years, compliance with exit colposcopy
was 88%.
Weaknesses: Comparisons of cumulative Incidence rate (CIRs) of high-grade cervical disease between subjects with a positive and those with a negative Cobas HPV tests is only limited to up to 3 years.
Recommendations for Labeling Changes Labeling incorporating the long term Post approval study were submitted and approved


MWP-HPV-159 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/18/2011 11/02/2011 Overdue/Received
1 year report 04/18/2012 04/24/2012 Overdue/Received
18 month report 10/17/2012 10/16/2012 On Time
2 year report 04/18/2013 04/03/2013 On Time
3 year report 04/18/2014 05/22/2014 Overdue/Received
Final Report 07/14/2014 07/14/2014 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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