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

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.
(Nasdaq: DIGE) 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 (Nasdaq: DIGE), 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
thehpvtest. 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, digene. 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.


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