GAITHERSBURG, Md., May 4 /PRNewswire-FirstCall/ -- The International Agency for Research on Cancer (IARC), part of the World Health Organization, has issued an assessment of available medical technologies for screening women for cervical cancer, the second most common cancer among women worldwide. The IARC evaluation, written by a panel of international experts, states that “there is sufficient evidence that testing for human papillomavirus (HPV) can reduce cervical cancer incidence and mortality rates.”
The IARC paper notes that the recognition that HPV infections are a necessary cause of cervical cancer has “profound implications for cancer prevention.” The agency’s paper also observes that a woman can be considered virtually free of cervical cancer risk in the absence of persistent infection with high-risk types of HPV. Thus, IARC says, the use of a test for “high-risk HPV types in screening and patient management is justified.” The report also recommends that health professionals and the population at large be educated on HPV and its connections with cervical cancer.
Thomas Wright, Jr., MD, Associate Professor of pathology at Columbia University Medical Center in New York, was one of the IARC panelists who developed the assessment, and spoke on HPV testing at the opening day of the 52nd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists, where more than 10 presentations highlighted the topic. “A key advantage of HPV testing is its high negative predictive value. This allows women to be certain that when the test is negative they don’t have cervical disease. In contrast, the sensitivity of the Pap is incredibly variable, depending on the lab and other factors. Another advantage of HPV testing is that it also predicts those women who might get disease in the future,” commented Dr. Wright. “Based on the information currently available, I would argue that clinicians would be better off using the HPV test as a first-line cervical cancer screening tool and reserving cytology as a way of determining which HPV DNA-positive women need additional testing. However, it’s currently approved only for use along with a Pap.”
The IARC assessment states that the most common methods for HPV testing are Digene’s Hybrid Capture(R) technology (marketed in the United States as the DNAwithPap(TM) Test) and polymerase chain reaction (PCR) techniques. However, they note that only Digene’s technology has “become an approved technique for screening and triage” of inconclusive cytology (Pap) results in western countries. The report also states that “new commercial testing systems need rigorous evaluation and validation before being adopted by the public health system.”
Digene’s test for high-risk types of HPV, approved by the U.S. Food and Drug Administration for routine screening in March 2003, has been studied in more than 100,000 women, with the findings published in more than 300 peer- reviewed publications.
“It is gratifying to see HPV testing, and Digene’s Hybrid Capture technology specifically, recognized by such a prestigious, global body as the World Health Organization’s International Agency for Research on Cancer,” says Evan Jones, Chairman and CEO of Digene. “WHO is understandably cautious and conservative before it takes a position, making this endorsement particularly meaningful.”
In releasing the IARC recommendations, Dr. Peter Boyle, the recently appointed director of the WHO cancer research agency, said the “next major challenge in cervix cancer prevention” will be making a simple, affordable HPV test available for widespread use around the world, even in areas with minimal resources. Earlier this year, Digene announced a partnership with the Program for Appropriate Technology in Health (PATH) to develop an HPV test customized to the unique needs of developing countries.
Note: Digene will host a Fiscal 2004 Third Quarter Results conference call on Thursday, May 6, at 10:30 a.m. EST. The call will be broadcast live over the company’s Web site, http://www.digene.com/.
About Digene
Digene Corporation , based in Gaithersburg, MD, develops, manufactures and markets proprietary 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(TM) is the only test for human papillomavirus approved by the FDA. It is approved by the agency for use in conjunction with the Pap test as a primary screen for cervical cancer and its precursors in women aged 30 and older, and as a follow-up to an abnormal Pap test result. For more information, visit http://www.thehpvtest.com/. Digene’s product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, as well as tests for blood viruses. Visit the company’s Web site, http://www.digene.com/. For more information, investors should contact Charles Fleischman at 301-944-7000; journalists should contact Pam Rasmussen, 301-944-7196.
This press release may contain 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 that could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians and the extent of reimbursement for the HPV test by third-party payers, 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, +1-301-944-7000, or PamRasmussen, +1-301-944-7196, both of Digene Corporation; or Sean Leous ofFinancial Dynamics, +1-212-850-5600, for Digene Corporation
