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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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CERVIVA Primary Screening Study


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General
Study Status Study Pending
Application Number /
Requirement Number		 P120007 S034/ PAS001
Date Original Protocol Accepted 02/03/2026
Date Current Protocol Accepted 02/03/2026
Study Name CERVIVA Primary Screening Study
Device Name Aptima HPV 16 18/45 Genotype Assay
General Study Protocol Parameters
Study Design Cross-Sectional Study
Data Source Other Data Source
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives To collect clinical data evaluating the clinical performance of the Aptima HPV Assay and the Aptima HPV 16 18/45 Genotype Assay compared to an HPV test that is FDA-approved for primary screening in women aged 25-29 years from CERVIVA Primary Screening Study, confirming the safety and effectiveness of the device in this specific age group.
Study Population All women aged 25 to 29 years presenting for cervical cancer screening.
Sample Size 1800 participants
Key Study Endpoints The ratio (Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay: FDA-approved HPV test) of clinical sensitivity and false positive rates for detection of CIN2+ and CIN3+.
Follow-up Visits and Length of Follow-up None


CERVIVA Primary Screening Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/04/2026 07/28/2026 On Time
1 year report 02/03/2027    
2 year report 02/03/2028    
3 year report 02/02/2029    


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

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