Roche Announces Expanded CE Mark Indication for cobas® 4800 HPV Test Supporting Its Use as a Primary Screen for Cervical

     Roche Announces Expanded CE Mark Indication for cobas® 4800 HPV Test
          Supporting Its Use as a Primary Screen for Cervical Cancer

  PR Newswire

  PLEASANTON, California, Nov. 27, 2012

-- HPV DNA detection finds disease missed by Pap cytology

PLEASANTON,California, Nov. 27,2012 /PRNewswire/ -- Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announces an expanded CE mark indication for the cobas®
4800 HPV Test. The newly expanded indication for the cobas® 4800 HPV Test as a
primary screen means Pap cytology is no longer required as a co- or pre-test
in countries that accept a CE mark. Persistent infection with Human
Papillomavirus is the principal cause of cervical cancer in women. The
expanded indication is supported by data to be presented at the International
Papillomavirus Conference, November 30-December 6, 2012 in San Juan, Puerto
Rico.

"HPV testing provides a more sensitive level of screening than the Pap test.
Whereas a Pap smear looks for abnormal cells, an HPV test looks for the
presence of HPV DNA itself," says Eduardo Franco, director, Division of Cancer
Epidemiology, McGill University, Montreal, Canada. "The prevalence of HPV
means that many women may test positive, so it is important to also identify
those most at risk to progress to cervical cancer. Genotyping for HPV types 16
and 18 provides sufficient additional specificity to identify the women most
at risk, and spares the rest from potentially unnecessary intervention. The
two HPV genotypes, 16 and 18, account for 70% of cervical cancer cases."

HPV DNA testing has more traditionally been used as a co-test or reflex test
to an abnormal or borderline cytology result. While Pap screening has
dramatically decreased the prevalence of cervical cancer over the past several
decades, Pap cytology has limitations due to low sensitivity and the
subjective nature of results interpretation. However, studies show that HPV
DNA testing is more sensitive than the Pap smear in picking up disease –
important in a front-line screen. In the landmark ATHENA study, it is shown
that the cobas® 4800 HPV Test finds disease that is missed by cytology - 1 in
10 women who tested positive for either HPV genotypes 16 or 18 by the Roche
cobas® 4800 HPV Test already had evidence of cervical pre-cancer, even though
their Pap test was normal.

Approximately 275,000 women worldwide still die of cervical cancer each year,
and many countries are in the process of piloting HPV DNA testing as a primary
screening replacement for Pap cytology. "Switching towards use of the cobas®
4800 HPV Test as a first line screen enables countries to implement strategies
that catch more disease with fewer medical interventions, allows physicians to
better manage their patients, and reduces economic costs to the healthcare
system," said Paul Brown, Head of Roche Molecular Diagnostics.

The cobas ® 4800HPVTest is the only clinically validated, and FDA-approved
test, that simultaneously provides pooled results on known "high-risk"
genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV
18, giving three results in just one test. The cobas® 4800 HPV Test has a
fully automated sample preparation workflow process, and unique efficiency
features allowing for higher throughput, making it well suited for high volume
screening programs.

"As an organization committed to women's health, Roche Diagnostics is
dedicated to keeping women healthy and improving patient care," Paul Brown
continued. "Combined with our products from the mtm business acquisition
announced last year, Roche has a broad cervical cancer prevention portfolio
which redefines cervical cancer screening and more effectively guides patient
management decisions."

International Papillomavirus Conference Roche will present data which supports
the cobas® 4800 HPV Test expanded indication as well as the broader Roche
cervical cancer portfolio at the International Papillomavirus Conference,
November 30-December 6, 2012 in San Juan, Puerto Rico.

Roche Satellite Symposium: Translating Science into Primary Screening
Practice Monday, 3 December, 12:30 PM – 1:45 PM, Puerto Rico Convention
Center, Ballroom B

Primary HPV screening: Impact of varying the age of initiation on the
performance of screening Wright TC, Cox JT, Sharma A, Apple R, Behrens
CMTuesday, 4 December, 2:00PM - 3:30PM, Room 208

3 Year cumulative incidence rates for high-grade cervical disease: Interim
analysis from the ATHENA study Castle PE, Wright TC, Stoler, MH, Zhang,
Behrens CM Tuesday, 4 December, 2:00PM- 3:30PM, Room 208

Intra-laboratory variation in the performance of liquid-based cytology;
insights from ATHENA Stoler MH, Wright TC, Apple R, Sharma A, Behrens CM
Tuesday, 4 December, 5:30PM - 7:30PM (Poster Session)

About the ATHENA Study Roche's landmark ATHENA study for the cobas® 4800 HPV
Test is the largest U.S.-based registration study for cervical cancer
screening, including more than 47,000 women.

About the cobas® 4800 HPV Test and cobas® 4800 System The cobas® 4800 HPV Test
is a qualitative in-vitro test for the detection of Human Papillomavirus in
patient specimens. The test utilizes amplification of target DNA by the
Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the
detection of 14 high-risk (HR) HPV types in a single analysis. The test
specifically identifies the high risk HPV types (31, 33, 35, 39, 45, 51, 52,
56, 58, 59, 66 and 68), while simultaneously also detecting the highest risk
types, HPV 16 and HPV 18. It is now available in the US and all countries
accepting a CE mark.

The cobas® 4800 System is designed to deliver new standards in laboratory
testing efficiency and medically relevant diagnostic information. The system
offers true walk-away automation and can run up to 282 tests in less than 12
hours, providing rapid analysis of screening tests for HPV infections meeting
the needs of the majority of clinical labs.

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.

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 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 2011, Roche had over 80,000 employees worldwide and invested over
8 billion Swiss francs in R&D. The Group posted sales of 42.5 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: www.roche.com .

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Website: http://www.roche.com
 
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