BURGESS HILL, England,
November 24, 2010 /PRNewswire/ -- 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 traditional method.
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. Thomas C.
Wright Jr., M.D. of Columbia
University, New York.
"Screening for high-risk HPV genotypes provides important additive
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 Pap smears.
"ATHENA is a landmark trial demonstrating how novel medical
diagnostics can address the limitations of cervical cancer
screening with Pap smears alone," said Paul
Eros, Director, Molecular Diagnostics for Roche in the UK.
"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."
Robert Music, Director of Jo's
Cervical Cancer Trust, said: "The charity 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.
About Roche
Headquartered in Basel,
Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company with
truly differentiated medicines in oncology, virology, inflammation,
metabolism and CNS. Roche is also the world leader in in-vitro
diagnostics, tissue-based cancer diagnostics and a pioneer in
diabetes management. Roche's personalised 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 almost 10 billion Swiss
francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech,
United States, is a wholly owned
member of the Roche Group. Roche has a majority stake in Chugai
Pharmaceutical, Japan. For more
information: http://www.roche.com.
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