Roche Introduces New Automated Clinical Laboratory System for CE-Marked Testing of Human Papillomavirus, Chlamydia and N. gonorrhoeae
By Roche Molecular Systems Inc., PRNETuesday, December 8, 2009
New cobas(R) 4800 System designed to increase laboratory efficiency and medical value
PLEASANTON, California, December 9 - Roche Molecular Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY) announced
today the launch of a new clinical laboratory system designed to increase
laboratory testing efficiency and to accommodate current and long-term
molecular diagnostic needs. The cobas(R) 4800 System combines CE-marked in
vitro diagnostic tests for Chlamydia trachomatis (CT), Neisseria gonorrhoeae
(NG) and human papillomavirus (HPV) testing with fully-automated sample
preparation and real-time polymerase chain reaction (PCR) technology. The
tests are designed to detect the 14 HPV high-risk genotypes widely accepted
to cause cervical cancer and bacterial DNA associated with chlamydia and
gonorrhea infections. By identifying 14 HPV genotypes, the cobas(R) 4800 HPV
test enables immediate identification of the two genotypes (HPV 16 and 18)
that put women at highest risk for cervical cancer. Designed to greatly
improve laboratory workflow and provide useful information that physicians
can immediately act upon, the new cobas(R) 4800 System is now available in
countries that accept CE-Mark.
"The introduction of our new cobas(R) 4800 System delivers on Roche's
commitment to provide advanced laboratory diagnostics equipment with
clinically relevant tests that are designed to provide actionable results for
clinicians," said Daniel O'Day, head of Roche Molecular Diagnostics. "This
new system also sets the stage for the delivery of additional diagnostic
tests in both microbiology and oncology."
The cobas(R) 4800 System is designed to deliver new standards in
laboratory testing efficiency and medically relevant diagnostic information
with increased testing throughput. With a throughput of up to 288 HPV tests
or 384 CT and NG tests in eight hours, the cobas(R) 4800 System is designed
to meet the needs of a majority of clinical laboratories. The system combines
state-of-the-art sample preparation with Roche's proprietary real-time PCR
technology for the amplification and detection of genetic material
(deoxyribonucleic acid or DNA) associated with HPV, CT or NG infections. The
intuitive, easy-to-use software integrates sample preparation, amplification
and detection, and results management.
"Complete automation of DNA testing for HPV and CT/NG has a lot of
advantages, such as standardization, reproducibility, lack of contamination,
and less hands-on time," said an early evaluator of the system, Dr. Mateos
Lindemann, Laboratory Director at the Hospital Ramon y Cajal in Madrid,
Spain. "Roche's automated cobas(R) 4800 System is very helpful and can be
easily integrated in the work flow of laboratories that must perform a high
number of routine tests."
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 (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66
and 68). Of these 14 genotypes, HPV types 16 and 18 have been identified as
the highest risk genotypes. Nucleic acid (DNA) testing is a sensitive and
non-invasive method for determining the presence of a cervical HPV infection.
About Chlamydia trachomatis
Chlamydia trachomatis is the most frequently reported bacterial sexually
transmitted disease (STD) in many countries in Europe, according to the
European Centre for Disease Prevention and Control (ECDC), and the second
most leading cause of STDs worldwide. Since approximately half of CT
infections are asymptomatic, many cases go undetected and untreated. The
consequences of an untreated chlamydial infection can be severe, leading to
urethritis, conjunctivitis or infertility, among other conditions. With
robust internal controls and by simultaneously amplifying and detecting two
different bacterial genome and plasmid regions, Roche's cobas(R) 4800 CT test
is designed to detect all known variants associated with clinical Chlamydia
trachomatis infections, including the Swedish mutant strain.
About Neisseria gonorrhoeae
Gonorrhea is a sexually transmitted disease caused by the bacteria
Neisseria gonorrhoeae. In 2006, a total of 358,366 cases of NG infection were
reported to the U.S. Centers for Disease Control (CDC), and it is estimated
that more than 700,000 persons acquire new infections each year. NG
infections in men can lead to urethritis or epididymitis, and in women can
lead to endocervical infection or pelvic inflammatory disease, among other
conditions. Roche's cobas(R) 4800 NG test is designed to simultaneously
amplify and detect two areas of a new DNA target region specific for
Neisseria gonorrhoeae. Dual PCR products allow the test to detect a wider
variety of NG variants without sacrificing sensitivity, while at the same
time vastly improving specificity.
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 2008, Roche had over 80,000 employees worldwide and invested almost 9
billion Swiss francs in R&D. The Group posted sales of 45.6 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.
cobas is a trademark of Roche.
For more information, please contact: Karin Bauer Roche Molecular Systems +1-925-730-8114 karin.bauer.kb2@roche.com
Karin Bauer of Roche Molecular Systems, +1-925-730-8114, karin.bauer.kb2 at roche.com
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