In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Transit. Adolescent B (as adults) : 18-21 yrs,
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.
2000 patients, 26 sites
Safety endpoints do not apply. The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and HPV 16/18
Followup Visits and Length of Followup
The study required 3 years of follow-up. Follow-up inculdes annual visits.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final 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).
Positive predictive value = 1.4% (95% CI: 0.0 ¨C 5.0) Negative predictive value = 99.6% (95% CI: 99.6-99.9)
Final Effectiveness Findings
Please see safety findings.
Study Strengths and 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.
Recommendations for Labeling Changes
The study results for the three year follow-up of women with NILM ¡Ý30 with normal
and the uncertainty surrounding the conclusions will be included in the label Study limitations).