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HPV DNA Testing Likely to Become Primary Cervical Cancer Screening Tool As Vaccine Use Expands, Predict International Experts

Posted on: Monday, 11 September 2006, 09:01 CDT

PRAGUE, Czech Republic, Sept. 11 /PRNewswire-FirstCall/ -- Experts speaking at the world's leading conference on the human papillomavirus (HPV) predicted that countries that widely implement the new HPV vaccine will eventually switch to DNA testing for the virus as their primary screening tool to identify women at risk of cervical cancer, Digene Corp. reported. HPV is the cause of cervical cancer, and Digene markets the only FDA-approved and CE-marked HPV test, which detects 13 high-risk types of the virus.

The consensus presented at the 23rd Annual International Papillomavirus Conference was developed by more than 100 experts in HPV, cervical cancer screening and vaccination, and was simultaneously published in a special supplement to Vaccine.

"Even after vaccination programs have been instituted and reasonable levels of coverage obtained, cervical cancer screening cannot be discontinued," said Thomas C. Wright, MD, lead author of the panel's conclusions and Associate Professor of the Division of Gynecologic Pathology College of Physicians and Surgeons at Columbia University in New York. "However, it will be important to re-evaluate how we screen. It is likely that the current approach of frequent screening using cytology (Pap testing) will prove to be too expensive and inefficient for many countries that also implement HPV vaccination -- particularly for those that publicly fund most of their healthcare. Most countries that introduce HPV vaccination will eventually want to switch to HPV DNA testing as the primary screening test, due (in part) to its better performance."

A working group led by Eduardo Franco, MD, Professor in the Departments of Oncology and Biostatistics at Canada's McGill University, concluded that simply doing Paps more frequently would not be a viable strategy, because the ability to accurately identify women with pre-cancerous or cancerous conditions using cytology is expected to decline as HPV vaccines are more widely used. This is because, the group said, the Pap relies on a "highly subjective" interpretation of changes seen in cervical cell samples -- contributing to its already high false-negative rate and the need for frequent re-testing. As widespread vaccination of women results in a lower incidence of abnormal cells, the "signal-to-noise" ratio will decrease -- potentially leading to greater tedium and fatigue in the laboratory, and a greater number of mistakes.

"The evidence in favor of HPV testing for screening is substantial. HPV testing is based on a highly standardized and validated assay system that suffers from none of the vagaries that typically affect Pap cytology," said Dr. Franco. "HPV testing is not prone to subjective interpretation and would thus maintain its high performance characteristics under low-lesion conditions."

Dr. Franco's working group concluded that HPV testing is the most suitable tool for routine screening, and that cytology should be reserved for follow-up evaluation of women who are found to have high-risk types of HPV. Currently, the Digene HPV Test is approved in the United States for use along with the Pap in women 30 and over.

Another benefit of widespread use of HPV DNA testing cited by the experts is the ability to track HPV infection over time as the vaccine becomes more widely used -- particularly if coupled with genotyping technology now under development by Digene and others to determine which specific high-risk types of the virus are present. "HPV DNA testing could provide an effective strategy to monitor long-term protection among vaccinated women," wrote Dr. Wright.

Worldwide, cervical cancer affects more than 400,000 women annually and, after breast cancer, is the second-most-common malignancy found in women.

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(R) is the only test for human papillomavirus approved by the U.S. Food and Drug Administration (FDA), 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(R) Test. These brand names do 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. For more information, visit http://www.thehpvtest.com/. Digene's HPV test is also CE-marked in Europe both routine, primary screening and follow-up evaluation of women with inconclusive Paps. It is marketed in more than 40 countries worldwide. In addition, Digene's product portfolio includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, as well as tests for blood viruses. For more information, visit the company's Web site, http://www.digene.com/. Investors also may contact Charles Fleischman at (301) 944-7000; journalists may contact Pam Rasmussen, (301) 944-7196.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of the future as there are a number of meaningful factors that could cause the Company's actual results to vary materially from those indicated by such forward-looking statements. Meaningful factors, which could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians, uncertainty of the company's future profitability, its ability to scale up manufacturing operations to meet any increased demand, the uncertainty regarding patents and proprietary rights, the success of the Company's marketing efforts, competition, risks inherent in international transactions, and the inability to obtain requisite additional financing, as well as other factors discussed in the Company's Securities and Exchange Commission filings. For other factors, reference is made to the discussion in the Company's annual and quarterly reports filed with the Securities and Exchange Commission.

Digene Corporation

CONTACT: Charles M. Fleischman, President of Digene Corporation,+1-301-944-7000; Investor Relations - Jonathan Birt of Financial Dynamics,+1-212-850-5634, Media - Pam Rasmussen of Digene, +1-301-944-7196, or SeanLeous of Financial Dynamics, +1-212-850-5755

Web site: http://www.digene.com/http://www.thehpvtest.com/

Source: PRNewswire-FirstCall

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