New Cervical Cancer Screening Test Set to Save the Lives of Women All Over the UK
– Landmark Study Confirms Accuracy of Roche’s Human Papillomavirus Test
for the Detection of Cervical Pre-Cancer Missed by Existing Screening Methods
The largest ever registrational study for a diagnostic product, involving
more than 47,000 women shows that the cobas(R) 4800 Human Papillomavirus
(HPV) test from Roche, is able to improve the detection of pre-cancerous
cells in women whose cervical smears tested normal. The ATHENA (Addressing
THE Need for Advanced) HPV Diagnostics trial demonstrated that more than 1 in
10 women in the trial aged 30 years and older who tested positive for HPV
genotypes 16 and/or 18 by the cobas 4800 HPV test had cervical pre-cancer
although their Pap1 smear was normal. The conclusion is that genotypes 16 and
18 if tested positive are high-risk indicators of cervical cancer. The data
points to the importance of genotyping to increase the accuracy of assessing
the risk of cervical cancer, especially screening for the two high risk HPV
genotypes 16 and 18, and underscores the limitations of relying on examining
and assessing the appearance of cervical cells under a microscope as is the
Cervical cancer causes approximately 1,000 deaths each year in the United
Kingdom2. The current system of cervical cancer screening, introduced across
the NHS in the late 1980s, is aimed at women aged 20 to 65 years. Women are
invited to attend screening every 3 or 5 years depending on age and the
system operates on a recall basis if the smear appears abnormal. Persistent
HPV infection can lead to the development of pre-cancerous and cancerous
cells in the cervix. The new cobas 4800 HPV test from Roche can provide early
detection of pre-cancerous changes in the cervix reducing the risk of
cervical cancer and thus has the potential to save lives.
“The ATHENA data shows that women who test positive for HPV 16 and/or 18
should be directly referred for closer examination of the cervix by
colposcopy,” said Dr.
information to Pap testing, and screening for the two highest risk types, HPV
16 and 18, should be included to provide predictive information about a
woman’s risk of having cervical pre-cancer or cancer.”
Findings from the ATHENA clinical trial, also show that women who tested
positive for HPV 16 and/or 18 with the cobas(R) 4800 HPV test and who had a
normal Pap smear test were at the same risk of having cervical pre-cancer as
women who tested positive for any of the 14 high-risk HPV types with an
equivocal smear. The latter clinical situation is broadly accepted to carry a
risk of pre-cancer that warrants immediate investigation, underscoring again
the importance of testing for HPV genotypes 16 and 18 in women with normal
“ATHENA is a landmark trial demonstrating how novel medical diagnostics
can address the limitations of cervical cancer screening with Pap smears
“If more women were tested for high-risk HPV subtypes, specifically subtypes
16 and 18, more cervical pre-cancer could be found and treated earlier. This
would prevent progression to cancer and ultimately save lives.”
is keen to help raise awareness of how important it is for women to go for
cervical screening when invited. This is evermore important as the most
recent statistics show a fall in the number of women taking up their
invitation for screening. It seems clear that HPV testing is going to take a
more important role in the cervical screening programme and it is good to see
that this HPV test has the ability of identifying those women at risk of
cervical pre-cancer at an earlier stage with improved detection.”
About the Roche ATHENA Clinical Trial
The Roche ATHENA trial for the cobas 4800 HPV test is the largest U.S.
based registration study of more than 47,000 women. The trial is designed to
answer current medical and scientific questions about the importance of
testing for high-risk HPV genotypes in cervical cancer screening and to
provide clinical information about the specific HPV genotypes that put women
at highest risk for developing cervical cancer.
About Human Papillomavirus and Cervical Cancer
Persistent infection with human papillomavirus is the principal cause of
cervical cancer in women, with HPV implicated in greater than 99% of cervical
cancers worldwide. Of the more than 118 different types of HPV, 14 types are
currently considered high-risk for the development of cervical cancer and its
precursor lesions. HPV types 16 and 18 have been identified as the highest
risk genotypes, detected in approximately 70 percent of cervical cancers.
Nucleic acid (DNA) testing is a sensitive method for determining the presence
of a cervical HPV infection.
About the cobas(R) 4800 HPV Test and cobas 4800 System
As demonstrated in the ATHENA trial, the Roche cobas(R) 4800 HPV test is
a new generation of HPV testing which simultaneously detects in one pass, 12
high-risk HPV types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and
68) as a pooled result, as well as HPV genotypes 16 and 18 individually.
Roche launched the cobas 4800 HPV Test with CE Approval in 2009.
Notes to the Editor
1. Pap smears allow for examination of cells from the cervix to detect
abnormalities that could lead to cervical cancer.
2. Source: NHS Cancer Screening Programme. Cervical cancer is the second
most common cancer in women under 35 in the UK.
3. Genotypes are variations in the genetic code (DNA) of an organism.
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diagnostics. Roche is the world’s largest biotech company with truly
differentiated medicines in oncology, virology, inflammation, metabolism and
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healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients. In 2009, Roche had over 80,000 employees worldwide and invested
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