• 4/17/2005
  • Gaithersburg, MD
  • press release
  • PRSNewswire

HPV DNA testing is ‘more sensitive than cervical cytology’ in detecting high grade cervical disease

A newly released Practice Bulletin from the American College of Obstetricians and Gynecologists (ACOG) recognizes testing for the human papillomavirus (HPV) as “more sensitive than cervical cytology [the Pap test]” for detection of pre- cancerous cells (CIN 2/3) and cervical cancer. Digene is the developer of the only FDA-approved test for high-risk types of HPV, the cause of virtually all cases of cervical cancer. The Digene HPV Test, also marketed as the DNAwithPap(TM) Test, is approved for use in conjunction with a Pap test for women age 30 and older.

ACOG’s April 2005 Practice Bulletin on HPV summarizes epidemiology and transmission of the virus, discusses the incorporation of HPV screening into clinical practice, and provides guidance on how to use the test results to tailor patient management. ACOG represents more than 45,000 physicians who provide health care for women.

The bulletin concludes, as a “Level A” recommendation “based on good and consistent scientific evidence,” that HPV testing together with a Pap test is more sensitive in detecting cancer than a Pap test alone:

* “Because HPV DNA testing is more sensitive than cervical cytology in detecting CIN 2 and CIN 3, women with negative concurrent test results can be reassured that their risk of unidentified CIN 2 and CIN 3 or cervical cancer is approximately 1 in 1,000.”
* “Studies using combined HPV testing with cervical cytology have reported a negative predictive value for CIN 2 and CIN 3 of 99 to 100 percent.”

As support for these conclusions, the Practice Bulletin cites a study in which 100 percent of cancerous lesions were detected using HPV DNA testing, compared to 58 percent with conventional cytology and 84 percent with liquid- based Paps. “Even newer liquid-based cytology techniques may miss 15 to 35 percent of cervical intraepithelial neoplasia (CIN) 3 or cancer. This carries important medical implications and has stimulated substantial interest in the development of more sensitive screening tools,” reports the ACOG bulletin.

The Practice Bulletin also addresses the potential use of HPV vaccines currently under development, but noted that “regardless of the success of [the product in Phase III clinical trials], it is unlikely that any vaccine will significantly decrease the incidence of cervical cancer in the near future.”

Evan Jones, Chairman and Chief Executive Officer of Digene Corporation, commented, “HPV DNA testing is the most effective new tool we have for improving cervical cancer screening. ACOG’s recognition of the significant data supporting its sensitivity in the detection of cervical disease and ACOG’s new guidance for incorporating the test into clinical practice help physicians offer their patients the best preventive assessment and care.”

Worldwide, cervical cancer affects more than 400,000 women annually and, after breast cancer, is the second most common malignancy found in women. In the United States, there are an estimated 10,370 cases of cervical cancer resulting in approximately 3,700 deaths each year.

About Digene

Digene Corporation based in Gaithersburg, MD, develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases — with a focus on women’s cancers and infectious diseases. The company’s hc2 High-Risk HPV DNA Test is the only test for human papillomavirus approved by the FDA, and is approved for both follow-up evaluation in women with inconclusive Pap results and for primary adjunctive screening with the Pap test in women age 30 and older. For primary adjunctive screening, it is marketed as both The Digene HPV Test and the DNAwithPap(TM) Test.