Cytopathology and More | ATHENA design, data—and the FDA’s decision

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1. U.S. Food and Drug Administration. 2014 meeting materials of the Microbiology Devices Panel, March 12, 2014: meeting materials FDA generated. Available at: www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/ucm388531.htm. Accessed June 12, 2014.
2. FDA approves first papillomavirus test for primary cervical cancer screening, April 24, 2014. Available at: www.fda.gov/newsevents/newsroom/pressannouncements/ucm394773.htm. Accessed June 12, 2014.
3. Simon K, Kondratovich M. FDA presentation March 12, 2014, Microbiology Devices Advisory Committee meeting. Available at: www.fda.gov/AdvisoryCommittees/Committees MeetingMaterials/MedicalDevices/MedicalDevicesAdvi soryCommittee/MicrobiologyDevicesPanel/ucm388531.htm. Accessed June 12, 2014.
4. Wright TC, Stoler MH, Sharma A, et al. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol. 2011;136:578–586.

Dr. Davey is assistant dean for graduate medical education and a professor of pathology, and Dr. Husain is a professor of pathology, both at the University of Central Florida College of Medicine, Orlando. Drs. Davey and Husain are members of the CAP Cytopathology Committee.