Preliminary Data from Roche ATHENA Cervical Cancer Trial Support Value of Human Papillomavirus Genotyping
MONTE CARLO, Monaco, Feb. 18 /PRNewswire-FirstCall/ -- Roche
Molecular Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY) announced
today that preliminary data from its ATHENA (Addressing THE Need
for Advanced HPV Diagnostics) trial support the importance of
screening for human papillomavirus (HPV) genotypes that put women
at highest risk for developing cervical cancer. ATHENA is a
prospective, double-blind, multi-centered, 47,000-patient,
U.S.-registration trial designed to demonstrate the effectiveness
of HPV detection as part of a cervical cancer screening program.
Thomas C. Wright Jr., M.D., of Columbia University presented the
preliminary data on February 18 during the Genotyping session
(Scientific Session 2) at the EUROGIN 2010 congress in
"The findings to date from the ATHENA trial support the growing
understanding that certain HPV genotypes are highly associated with
the development of high-grade cervical intraepithelial neoplasia
(CIN grade 2 or higher), a direct precursor to cervical cancer,"
said Dr. Wright.
Persistent infection with HPV is the principal cause of cervical
cancer in women, with HPV implicated in greater than 99 percent of
cervical cancers worldwide. Cervical cancer is a global public
health problem, accounting for 10 percent of all cancers in women.
While the Papanicolaou cytology smear (Pap smear) has reduced
deaths from cervical cancer by 70 percent in developed countries,
the Pap smear has demonstrated limited ability to detect cervical
cancer and its pre-cancer lesions based on a single test result. As
a result, physicians are increasingly using HPV DNA testing
together with Pap smears to more precisely determine a woman's risk
for developing cervical cancer.
"While significant progress has been made in screening for
cervical cancer over the past 50 years, it is clear that testing
for HPV DNA as part of a cancer screening program allows the
identification of cancer and its precursors earlier than when Pap
smear alone is used," said Teresa Wright, M.D., chief medical
officer, Roche Molecular Diagnostics. "In HPV positive women 30
years and older with normal pap smears, current screening
guidelines recommend testing for specific HPV genotypes to identify
those with the highest risk for cancer and its precursors. The
demonstrated cervical disease in women with HPV genotype 16
enrolled in ATHENA supports these recommendations."
About the Roche ATHENA Trial
The Roche ATHENA trial is designed to answer current medical and
scientific questions about the importance of testing for human
papillomavirus (HPV) genotypes in cervical cancer screening and to
provide additional information about the specific HPV genotypes
that put a woman at highest risk for developing cervical cancer.
The Roche ATHENA HPV trial enrolled 47,000 women and screened
participants for cervical cancer using the Pap test and HPV DNA
tests for 14 genotypes that are known to put women at high risk.
All women with a positive HPV test and a positive Pap test in the
trial were referred for further blinded investigation of whether
they had cervical cancer or pre-cancerous disease.
As reported today, preliminary analysis of data from more than
8,000 women who underwent biopsy in the ATHENA trial demonstrated
that those with HPV genotype16 had the highest rate of pre-cancer,
also known as cervical intraepithelial neoplasia (high-grade CIN2
and CIN3+ lesions). In addition, HPV genotype 18 was associated
with increased rates of CIN3+ disease, particularly in women 36
years and older. Data from the preliminary analysis also
demonstrated that further evaluation of HPV genotypes associated
with high-grade cervical disease may be warranted.
About Human Papillomavirus and Cervical Cancer
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 (types 16, 18, 31, 33, 35, 39, 45,
51, 52, 56, 58, 59, 66 and 68). Nucleic acid (DNA) testing is a
sensitive and non-invasive method for determining the presence of a
cervical HPV infection. Roche launched its DNA test, the cobas®
4800 HPV Test, with CE Mark in 2009. This test is not available in
the United States.
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 personalized 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
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Source: Roche Molecular Systems, Inc.
CONTACT: Karin Bauer of Roche Molecular Systems, Inc.,
Web Site: http://www.roche.com/
Posted: February 2010