Digene Corporation Release: HPV DNA Testing And HPV Vaccines Described By Experts As Combination That Offers Best Hope Of Preventing Cervical Cancer
PARIS, April 27 /PRNewswire-FirstCall/ -- Experts speaking at one of the world's leading conferences on reproductive health described the combination of HPV testing with the soon-to-come HPV vaccines as the best hope for preventing cervical cancer.
Speaking at the EUROGIN (European Research Organization on Genital Infection and Neoplasia) conference, the experts focused on the emerging role of HPV (human papillomavirus) testing as a standard of care for cervical cancer screening, as well as on the anticipated approval of the first vaccine developed to protect against the two most high-risk forms of HPV. Virtually all cervical cancers are caused by HPV, and Digene Corp. markets the only FDA-approved and CE-marked HPV test, which detects 13 high- risk types.
"The use of HPV DNA testing in primary cervical cancer screening is increasing quite rapidly and will become essentially standard of care over the next several years," predicted Thomas Wright, MD, Associate Professor of the Division of Gynecologic Pathology College of Physicians and Surgeons at Columbia University in New York, speaking in the conference's keynote address. "We are looking forward now to the decade of the HPV vaccines. However, vaccines are not a silver bullet. Primary prevention must go hand in hand with secondary prevention." Later in the conference, Dr. Wright was honored with one of EUROGIN's Distinguished Services Awards.
Worldwide, cervical cancer affects more than 400,000 women annually and, after breast cancer, is the second-most-common malignancy found in women. Although regular use of cytology (Pap testing) has dramatically reduced the incidence of cervical cancer in many countries, it is not foolproof. Walter Kinney, MD, Medical Director of the Kaiser Permanente-Northern California, calculated that diagnosis of CIN-2/3 (pre-cancerous cervical cells) can be increased by 40 percent by effectively following up on women whose Pap results are normal but who test positive for high-risk HPV. Kaiser was one of the first health plans to make HPV testing for women age 30 and older a standard of care, and Dr. Kinney presented data at the meeting on more than 200,000 women in this age group who have received the HPV test from Kaiser staff. "Of all the individuals involved in the process, patients are the least resistant to new technologies like the HPV test" because they welcome the additional peace of mind it offers, said Dr. Kinney. He received EUROGIN's prestigious Jan Walboomers Award, given to the author of the best original paper presented.
"Now, with the advent of the vaccines, we have a combination that is even more powerful," said Xavier Bosch, MD, of the Institut Catala D'Oncologia in Barcelona, Spain, speaking at a symposium titled HPV Screening in the Era of Vaccines: New Strategies for Prevention of Cervical Cancer. "The excitement over the first vaccine should cause a phenomenal increase in awareness among healthcare professionals and the public of the link between HPV and cervical cancer. However, there will be a huge number of women who still require screening, in part because they have already been exposed to the types of HPV targeted by the vaccines. That will lead to a demand by governments, payers and others for the most reliable screening protocol, and I expect there will be international recognition of the evidence in support of the superiority of HPV testing."
Attila Lorincz, PhD, Digene's Chief Scientific Officer and Senior Vice President of Research and Development, summed up what he described as the major theme of EUROGIN. "Science has culminated in what may be close to the ideal 'prevention solution': two highly targeted HPV technologies that work together to prevent most infections and to identify early those that do develop, stopping cervical cancer in its tracks."
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; or Investors - Jonathan Birt of Financial Dynamics,+1-212-850-5634, or Media - Pam Rasmussen of Digene, +1-301-944-7196; orSean Leous of Financial Dynamics, +1-212-850-5600