Cytopathology in focus: Review of FDA-approved molecular testing platforms for HPV
January 2020—The Food and Drug Administration approved in 2001 the first testing modality for the detection of HPV in gynecological cytological specimens. To date, there are now five FDA-approved testing modalities, and molecular testing for high-risk HPV has become commonplace. Numerous studies have shown that high-risk HPV testing is more sensitive in detecting high-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade two and above (HSIL/CIN2+) than cytology alone, but that cytology is more specific.