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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Cervista HPV HR Assay


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General
Application Number P080015 / PAS001
Current Plan Approved 03/12/2009
Study Name Cervista HPV HR Assay
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a prospective, cohort study. The study consists of women that are 30 years or older with a normal pap test and Cervista HPV test at baseline. The enrolled subjects come back for their routine screening visits on an annual basis and have a Pap test at each follow-up visit.
Study Population Description Study Population: Women 30 years or older who have a NILM cytology result at baseline. Indication: The Cervista HPV 16/18 test can be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to screen to assess the presence or absence of high-risk HPV types 16 and 18 in women 30 years and older.
Sample Size 2000 patients, 26 sites
Data Collection Safety endpoints do not apply. The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and HPV 16/18 test.
Follow-up Visits and Length of Follow-up The study required 3 years of follow-up. Follow-up inculdes annual visits.
Final Study Results
Interim Safety Information Saftey information not applicable
Number of Patients 2026
Number of Sites 26
Follow-up Rate 3 years
Safety Findings The estimates for Cervista HPV 16/18 positive over Cervista 16/18 negative relative cumulative risk at the end of 3 years is 0.015 as compared to 0.009 (p=0.630).



Sensitivity = 20.0% (95% CI: 3.6 ¨C 62.4) Specificity = 95.1% (95% CI: 93.8 ¨C 96.1)

Positive predictive value = 1.4% (95% CI: 0.0 ¨C 5.0) Negative predictive value = 99.6% (95% CI: 99.6-99.9)

Effect Findings Please see safety findings.
Strengths & Weaknesses The cumulative 3 year incidence for Cervista HPV 16/18 test is based on one HPV positive with CIN2+ were compared to two HPV negative with CIN2+. Thus, it is unclear if data from the PAS supports that Cervista HPV 16/18 test (P80015) is more effective in triaging women to colposcopy.



Another weakness is the generalizability of the study as

the absolute 3 year cumulative risk of developing ¡ÝCIN2 in Cervista HPV HR [1.1% (4/362)] positive women is lower in the Cervista NILM ¡Ý30 population in comparison to cross-sectional and longitudinal data using other approved assays.

Label Changes The study results for the three year follow-up of women with NILM ¡Ý30 with normal cytology

and the uncertainty surrounding the conclusions will be included in the label Study limitations).







Cervista HPV HR Assay Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/13/2009 09/14/2009 Overdue/Received
1 year report 03/12/2010 03/11/2010 On Time
18 month report 09/10/2010 09/08/2010 On Time
2 year report 03/12/2011 03/08/2011 On Time
3 year report - final report 03/11/2012 07/27/2011 On Time
response to R7 RDEF - FINAL REPORT 10/22/2012 10/19/2012 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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