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.
No issues concerning the safety of the APTIMA HPV Assay on either TIGRIS or PANTHER
platform were reported by the sponsor or identified by the reviewer.
Final Effectiveness Findings
The absolute risk of cervical disease is greater in subjects with positive APTIMA HPV Assay
results than in subjects with negative APTIMA HPV Assay results.
Study Strengths and Weaknesses
This study was able to demonstrate that the APTIMA HPV assay¿s postmarket performance is characterized
by relatively high sensitivity and specificity, especially for identifying women who have higher risk of developing high-grade and invasive cervical cancer. However, this study had a limited ability to stratify women with the low-grade lesions. In addition, the study did not address the relevance of HPV positivity in the absence of cytological abnormalities which would require de novo data collection with a longer follow-up.