Spanish Medical Societies Issue First European National Consensus Guidelines Recommending HPV DNA Testing for Cervical Cancer Sc
14 Diciembre 2006 - 8:00AM
PR Newswire (US)
GAITHERSBURG, Md., Dec. 14 /PRNewswire-FirstCall/ -- 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.
(NASDAQ:DIGE). 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. About Digene A leader in
molecular diagnostics, Digene develops, manufactures and markets
proprietary DNA and RNA tests, with a focus on women's health. The
company's flagship product, the Digene(R) HPV Test, is the only
FDA-approved and CE-marked test for the human papillomavirus, the
cause of essentially all cervical cancers. Digene's product
portfolio also includes tests for the detection of other sexually
transmitted infections, including chlamydia and gonorrhea. Digene
tests are marketed in more than 40 countries worldwide.
Headquartered in Gaithersburg, MD, Digene is traded on NASDAQ under
the symbol DIGE. For more information, visit http://www.digene.com/
and http://www.thehpvtest.com/. 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. DATASOURCE: Digene Corp. CONTACT: Investors: Albert
Fleury, Digene, +1-301-944-7000; or Evan Smith, Financial Dynamics,
+1-212-850-5606; or Media: Pam Rasmussen, Digene, +1-301-944-7196;
or Sean Leous, Financial Dynamics, +1-212-850-5755 Web site:
http://www.digene.com/ http://www.thehpvtest.com/
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