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: 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.
2000 patients, 26 sites
There are no safety endpoints, The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and high risk
HPV test result.
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 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.
Positive predictive value = 1.6% (95% CI: 0.6 ¨C 2.2) Negative predictive value = 99.8% (95% CI: 99.6-100.0)
Final Effectiveness Findings
Please see safety findings.
Study Strengths and 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.
Recommendations for Labeling 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.