• HPV Facts
• HPV Types
• The digene HPV Test
  • Features & Benefits
  • Primary Screening (30+)
  • ASC-US Reflex Testing
  • Expert Quotes
• HPV Vaccines & Screening

Overview

The digene HPV Test^* is the only 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.