The Digene^® HPV Test* (also known as the DNAwithPap^® Test) is the only FDA–approved test to screen for the presence or absence of the high–risk oncogenic HPV types. It provides an objective risk indicator for the development of high–grade cervical disease and cancer by detecting the 13 clinically–relevant high–risk HPV types.

The Digene^® HPV Test holds two FDA–approved indications:

HPV vaccines + HPV screening: Learn more.

• Primary adjunctive screening with a Pap test for women age 30 and older to detect the presence or absence of high–risk HPV for use as a guide for patient management in cervical cancer screening programs.
• Reflex HPV testing: Triage for women with (ASC–US) Pap results to determine appropriate follow–up.

The Digene^® HPV Test and the Pap test together offer unprecedented sensitivity for high–grade cervical disease and cancer. While the Pap on its own detects cellular changes The Digene^® HPV Test detects the recognized necessary causal factor of the disease – HPV – providing an objective measure of risk for clinicians and patients.

HPV testing along with a Pap test is emerging as a standard of care and has been incorporated into treatment guidelines and recommendations by the:

• American Cancer Society (ACS)
• American College of Obstetricians and Gynecologists (ACOG)
• Association of Reproductive Health Professionals (ARHP)
• American Society for Colposcopy and Cervical Pathology (ASCCP)
• National Association of Nurse Practitioners in Women's Health (NPWH)
• American Medical Women's Association (AMWA)

* "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.