Overview

The digene HPV Test* is the first FDA-approved test that screens for the presence or absence of oncogenic HPV types. It provides an objective risk indicator for the development of high-grade cervical disease and cancer by detecting the 13 clinically most important high-risk HPV types.

The digene HPV Test has been approved for two indications:

  • Primary adjunctive screening with a Pap: Screening of women age 30 and older to identify women most likely to have CIN 2/3 or cancer and thus in need of colposcopy.

  • Reflex HPV testing: Triage for women with ASC-US Pap results to determine appropriate follow-up.

When used together for women 30+, the digene HPV Test and the Pap offer unprecedented sensitivity for high-grade cervical disease and cancer.

HPV testing along with cytology is emerging as a standard of care and has been incorporated into treatment guidelines and recommendations issued 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 U.S. 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 QIAGEN product that tests for several types of the virus commonly referred to as "low-risk HPV," which are not associated with cervical cancer.