HPV Testing Most Accurate Method for the Detection of High Grade Cervical Disease and Cancer - Digene's
Hybrid Capture(R)II HPV Test Superior Over Four Other Methods for Cervical Cancer Screening -
GAITHERSBURG, Md., Feb 11, 2000 /PRNewswire via COMTEX/ -- Digene Corporation
(Nasdaq: DIGE) announced today that data presented at the Society of Gynecologic
Oncologists' 30th Annual Meeting in San Diego reported that HPV testing detected
more high-grade cervical disease and cervical cancer when compared with four
other diagnostic methods, including liquid cytology (collected at the time of a
Pap smear) and colposcopy. The study further validates the mounting body of
evidence that reinforces the utility and efficacy of HPV testing when used as a
tool to screen for cervical cancer.
Preliminary data from a screening clinical trial involving 1,977 women aged
between 35 and 45 years in Shanxi Province, China showed that the Hybrid
Capture(R) II HPV Test had a sensitivity for detection of disease of 98%. The
specificity of Hybrid Capture for the detection of disease was 85%. Liquid
cytology also performed well in the study, providing a sensitivity of 94% and a
specificity of 78%. Colposcopy had a sensitivity of just 81% in the trial, with
a specificity of 77%. Other tests such as direct visual inspection by acetic
acid and fluorescent spectroscopy did not perform as well as colposcopy or
cytology methods, and had considerably lower specificity and sensitivity when
compared to that of the Hybrid Capture Test.
Jerome Belinson, M.D., Chairman, Department of Gynecology and Obstetrics,
Cleveland Clinic and lead author of the study said, "By virtue of the design of
our study it allows us to determine the true sensitivity and specificity of the
currently available screening technologies in the age group studied. We can now
design more cost-effective screening programs based on a population's resources
and prevalence of disease. These data certainly support the incorporation of
primary HPV testing in future screening programs in women over the age of 35."
Commenting on the data, Attila Lorincz Ph.D., Vice President, Research and
Scientific Director, Digene Corporation stated, "This study is important because
it provides an unbiased set of results in that every woman was completely
assessed for disease. The data demonstrate that in high-risk populations such as
the one in this study, HPV testing by Hybrid Capture is more sensitive and has a
lower false positive rate than other cervical screening methods. The study
supports the role of HPV testing as a primary screening test in addition to it's
accepted utility for the triage of ASCUS Pap results."
Digene Corporation (Nasdaq: DIGE), based in Gaithersburg, Maryland, develops,
manufactures and markets proprietary DNA and RNA testing systems for the
screening, monitoring and diagnosis of human diseases. The Company has developed
and is commercializing its patented Hybrid Capture(R) Gene Analysis System and
tests in three areas: women's cancers and infectious diseases, blood viruses,
and pharmaceutical clinical research. Digene's primary focus is in women's
cancers and infectious diseases where the Company's lead product is the only FDA
approved test for human papillomavirus, or HPV, which is the cause of greater
than 99% of cervical cancer cases. The Digene HPV Test is used in the U.S. as an
adjunct to the Pap smear for cervical cancer screening and is being marketed in
selected countries as a primary cervical cancer screen either in conjunction
with or separate from the Pap smear. The Company's product portfolio also
includes DNA tests for the detection of other sexually transmitted infections,
including chlamydia and gonorrhea, and tests for blood viruses.
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 which
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 payors, 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.
SOURCE Digene Corporation
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