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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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Application Number P080014 / 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: 1) To screen patients with atypical squamous cells of undetermined significance cervical cytology results to determine the need for referral to colposcopy. 2) In women 30 years and older, the Cervista HPV HR test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types.
Sample Size 2000 patients, 26 sites
Data Collection There are no safety endpoints, The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and high risk HPV test result.
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 cumulative risk of ¡ÝCIN2 after 3 years among subjects who had a positive Cervista HPV HR result was 0.013 compared to 0.001 among subjects with HPV negative results when followed for 3 years (p=0.002).The clinical sensitivity, specificity, NPV and PPV of the test For detection of >= CIN2, based on 6diseased subjects.

Sensitivity = 66.7% (95% CI: 30.0-90.3) Specificity = 81.6% (95% CI: 79.4 ¨C 83.5)

Positive predictive value = 1.6% (95% CI: 0.6 ¨C 2.2) Negative predictive value = 99.8% (95% CI: 99.6-100.0)

Effect Findings Please see safety findings.
Strengths & Weaknesses Of the 2026 women enrolled in the PAS, only 6 had the study outcomes/CIN2+, namely 4 HPV positive and 2 HPV negative after 3 years. 36 subjects had missing data for CIN2+ determination in the PAS as compared to the 6 CIN2+ evaluated in the PAS. However, missing data analyses evaluated the study results as robust. 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 It is recommended that the label be updated to reflect the study results for the three year follow-up of women with NILM ¡Ý30 with normal cytology.

Cervista HPV HR Assay Schedule

Report Schedule
Date Due
FDA Receipt
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
additional information for final report 01/03/2013 01/03/2013 On Time
response to RDEF -final report 03/10/2013 03/07/2013 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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