Roche submits filing to FDA for cervical cancer primary screening indication
for cobas® HPV Test
PLEASANTON, Calif., July 8, 2013
PLEASANTON, Calif., July 8,2013 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced it has submitted a Premarket Approval (PMA) supplement
to the U.S. Food and Drug Administration (FDA) seeking the addition of a
cervical cancer primary screening indication for the cobas^® HPV Test.
Approval of the expanded indication would mean the cobas^® HPV Test could be
used as the first-line test rather than Pap cytology as part of a cervical
cancer screening strategy. The filing includes new three-year follow-up data
from the ATHENA study, Roche's landmark U.S.-based registration trial,
including more than 47,000 women screened for cervical disease with Pap and
HPV (Human Papillomavirus) tests.
"This milestone demonstrates our long-term commitment to cervical cancer
prevention and women's health," said Paul Brown, Head of Roche Molecular
Diagnostics. "Our ATHENA study validates the value of HPV DNA detection and we
are confident that these data will demonstrate to the FDA that we have
established the clinical utility of the cobas^® HPV Test in primary screening
for physicians and their patients."
The cobas^® HPV Test is the only FDA approved test that provides pooled
results for known high risk genotypes and in addition, simultaneously provides
individual results for the 2 highest risk genotypes, HPV 16 and HPV 18. Data
from the ATHENA study published in the American Journal of Obstetrics &
Gynecology in November 2012 by Cox et al. show strategies that incorporate
high-risk HPV DNA testing with simultaneous detection of genotypes 16 and 18
as an initial screening test can detect more cervical disease than strategies
that use Pap alone, representing significant potential benefits for patients.
The cobas® HPV Test received FDA approval in April 2011 to screen patients age
21 and older with abnormal Pap test results and to co-test with Pap in women
ages 30 to 65 to assess the presence or absence of high-risk HPV genotypes. In
November 2012, the test was also CE marked for use as a primary screening test
in countries that accept the CE mark.
About the cobas^® HPV Test and cobas^® 4800 System
Clinically validated by the landmark ATHENA trial, thecobas^®HPV Test is the
only FDA-approved HPV assay that provides specific genotyping information for
HPV 16 and 18, the highest-risk types, while simultaneously reporting the 12
other high-risk HPV types as a pooled result, all in one run, from one patient
The test is performed on the cobas^® 4800 system, which offers true walk-away
automation of nucleic acid purification, PCR (polymerase chain reaction)
set-up and real-time PCR amplification and detection to help laboratories
achieve maximum efficiency. The system also runs the cobas^® CT/NG Test
(chlamydia/gonorrhea), the cobas^® BRAF V600 Mutation Test and the cobas^®
EGFR Mutation Test.
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 percent of
cervical cancers worldwide. According to the National Cancer Institute, there
are 12,200 new cases of cervical cancer in the United States annually and
4,210 deaths due to the disease. The World Health Organization estimates there
are 470,000 new cases of cervical cancer annually.
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, infectious diseases, inflammation, metabolism and neuroscience.
Roche is also the world leader in in vitro diagnostics and tissue-based cancer
diagnostics, and a frontrunner 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 2012 Roche had over 82,000 employees worldwide and invested over
8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss
francs. Genentech, in the United States, is a wholly owned member of the Roche
Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For
more information, please visit www.roche.com.
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