ASC–US reflex testing: HPV testing can improve diagnostic confidence and management of patients with inconclusive or abnormal Pap results

• The Digene^® HPV Test is the standard of care for the resolution of Pap tests interpreted as atypical squamous cells of undetermined significance (ASC–US).
• It was first approved by FDA for this indication in 2000, and then approved for primary screening together with the Pap test (in women age 30 and older) in 2003.
• The Digene^® HPV Test is the only FDA–approved HPV DNA test and detects the 13 clinically–relevant high–risk HPV types associated with cervical cancer.

ASC–US reflex HPV testing:

• Provides a high level of diagnostic confidence
• Minimizes the risk of missed disease
• Helps determine the need for colposcopy
• Provides objective results and enables HPV–negative women to be returned efficiently to routine screening with a high degree of confidence that she is at little to no risk of developing high–grade cervical disease or cancer
• Reduces anxiety of HPV–negative women with ASC–US
• Reduces unnecessary consultations and procedures

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¹ Clavel C, Masure M, Bory J–P, et al. Hybrid Capture^® II–based human papillomavirus detection, a sensitive test to detect in routine high–grade cervical lesions. Brit J Cancer 1999; 80(9): 1306–1311.
² Agency for Health Care Policy and Research. Evaluation of cervical cytology. Summary, evidence report/technology assessment: Number 5, January 1999.
³ Manos MM, Kinney WK, Hurley LB. Identifying women with cervical neoplasia. Using human papillomavirus DNA testing for equivocal Papanicolaou Results. JAMA 1999; 281: 1605–10.

* "The Digene HPV Test" was approved by the US FDA and is also known to laboratories and physicians as the "hc2 High–Risk HPV DNA Test^®" and "DNAwithPap^® Test." This does not refer to the Digene product that tests for several types of the virus commonly referred to as "low–risk HPV," which are not associated with cervical cancer.