DREIEICH, Germany, December 18 /PRNewswire/ -- Four Spanish medical societies have published national consensus cervical cancer prevention guidelines that recommend HPV DNA testing for routine, primary screening for women over 35, announced Digene Corp. In addition to HPV DNA testing for primary screening, the guidelines also recommend use of the test for "proof of cure" following treatment, as well as for follow-up evaluation of women with inconclusive Pap results. The Digene(R) HPV Test, which uses the company's proprietary Hybrid Capture(R) II (hc2) technology, is the only test for detecting the presence of high-risk types of the human papillomavirus (HPV), the cause of cervical cancer, that is clinically validated and both FDA-approved and CE-marked.
The guidelines recommend use of the HPV DNA test in conjunction with a Pap test. However, they go on to observe that "it has been suggested that the most appropriate use of the HPV DNA test. . .would be as the sole screening test, with subsequent Pap testing only of women with HPV." The guidelines call for further evaluation of this option.
The guidelines, which also were approved by the Spanish Association of Cervical Pathology and Colposcopy, the Spanish Association of Cytology and the Spanish Association of Pathology, conclude that HPV DNA testing will be increasingly important as the new HPV vaccine becomes more widely used. The vaccine protects previously unexposed women against two of the cancer-causing types of HPV that represent approximately 70 percent of cervical cancers.
"As vaccination causes the prevalence of cervical cancer to decline, the Pap test -- which must be repeated frequently to be accurate -- will become too expensive and inefficient for the budgets of public health systems to absorb along with the vaccine," state the guidelines. "Because of that, screening programs must be re-evaluated. The HPV DNA test has all of the characteristics of the ideal test for primary screening in such conditions."
Attila Lorincz, PhD, Digene's Chief Scientific Officer and inventor of the Digene HPV test, highlighted the importance of the guidelines: "The endorsement of HPV DNA testing by the premiere medical professional societies in Spain signals the beginning of a shift in the standard of practice in Europe towards broader use of HPV testing in cervical cancer prevention programs," he said. "This is good news for the women of Europe, who have generally lagged behind women in the United States in access to the best cervical cancer prevention technologies."
The new guidelines, which are published in Progresos, the official journal of the Spanish Association of Gynecology and Obstetrics, note that Digene's Hybrid Capture II (hc2) HPV Test "continues to be the only FDA-approved technology" for detecting the DNA of high-risk types of HPV. "A benefit of using the HPV DNA test is that it is objective, with high reproducibility and easy automation, allowing its use in countries without the infrastructure needed for Pap testing and without depending on subjective interpretation," the document states.
While the Pap test relies on a laboratory technician to manually look for cell changes that may signal cervical disease, Digene's hc2 HPV DNA Test uses advanced molecular technology to identify the presence of the genetic code (DNA) of 13 high-risk types of HPV. Worldwide, cervical cancer affects more than 400,000 women annually and, after breast cancer, is the second most common malignancy found in women.
For further information:
http://www.digene.de
Digene Deutschland GmbH
Philipp-Reis-Str. 14
63303 Dreieich
Press Contact:
MasterMedia GmbH
Dr. Werner Bauch
Schulterblatt 120
20357 Hamburg
Tel.+49-040-507-113-29
E-Mail: dr.bauch@mastermedia.de
For further information: http://www.digene.de, Digene Deutschland GmbH, Philipp-Reis-Str. 14, 63303 Dreieich; Press Contact: MasterMedia GmbH, Dr. Werner Bauch, Schulterblatt 120, 20357 Hamburg, Tel.+49-040-507-113-29, E-Mail: dr.bauch@mastermedia.de
