|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080015 / PAS001 |
| Date Original Protocol Accepted |
03/12/2009
|
| Date Current Protocol Accepted |
03/12/2009
|
| Study Name |
Cervista HPV HR Assay
|
| Device Name |
CERVISTA HPV 16/18
|
| 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 Objectives |
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 |
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
|
| Key Study Endpoints |
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.
|
| Interim or Final Data Summary |
| Interim Results |
Saftey information not applicable
|
| Actual Number of Patients Enrolled |
2026
|
| Actual Number of Sites Enrolled |
26
|
| Patient Follow-up Rate |
3 years
|
| 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).
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)
|
| Final Effect Findings |
Please see safety findings.
|
| Study 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.
|
| Recommendations for Labeling 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).
|
