Roche receives FDA clearance to use additional specimen types for chlamydia and gonorrhea test

 Roche receives FDA clearance to use additional specimen types for chlamydia
                              and gonorrhea test

Expanded application for real-time PCR-based test provides laboratories with
comprehensive CT/NG test on fully automated cobas® 4800 System

PR Newswire

PLEASANTON, Calif., Dec. 4, 2013

PLEASANTON, Calif., Dec. 4, 2013 /PRNewswire/ --Roche (SIX: RO, ROG; OTCQX:
RHHBY) announced today that it has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for the use of four additional specimen
types with the cobas® CT/NG v2.0 Test to help physicians diagnose Chlamydia
trachomatis (CT) and Neisseria Gonorrhoeae  (NG) infections in symptomatic
and asymptomatic patients. In addition to self-collected vaginal swabs
(collected in a clinical setting) and male urine specimens, the test may now
be used with endocervical and clinician-collected vaginal specimens, female
urine specimens collected in cobas® PCR media, and cervical specimens
collected in PreservCyt® solution.

The clinical performance of the cobas® CT/NG v2.0 Test using the additional
specimen types was validated in the VENUS Studies, which included 6,004
patients (5,266 females and 738 males), representing over 26,000 specimens
collected in two clinical studies.

"International efforts directed at reducing the CT/NG burden through more
timely and accurate detection of CT/NG will be accelerated by diagnostic
testing which allows for identification of both symptomatic and asymptomatic
patients," said Dr. Jane Gibson, Ph.D.Professor of Pathology, University
ofCentral FloridaHealth Sciences Campus."The cobas® CT/NG v2.0 Test has
demonstrated consistent, dependable performance using a broad spectrum of
approved sample types, which provides laboratories with a highly efficient
tool for use in both routine screening and diagnostic patient testing."

"With the addition of these specimen types, the cobas® CT/NG v2.0 Test now
provides U.S. labs with a comprehensive offering for chlamydia and gonorrhea
testing," said Paul Brown, head of Roche Molecular Diagnostics. "This will
enable more labs running the cobas® 4800 System to combine CT/NG and HPV
testing onto a single automated platform and further optimize their workflow."

The test is performed on the cobas® 4800 System, which is currently the only
FDA-approved system to offer primary vial loading for both CT/NGand HPV
testing. The streamlined workflow can help labs reduce costs, improve
turnaround time and free staff to spend time on other critical tasks.

About the cobas® CT/NG v2.0 Test
The cobas® CT/NG v2.0 Test is a qualitative in-vitro test for the detection of
CT/NG DNA in patient specimens. It utilizes amplification of target DNA by
Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the
detection of CT/NG in a single analysis.

About the cobas® 4800 System
The cobas® 4800 System offers true walk-away automation of nucleic acid
purification, PCR set-up and real-time PCR amplification and detection to help
laboratories achieve maximum efficiency. The system also runs the cobas® HPV
Test, the cobas® BRAF V600 Mutation Test and the cobas® EGFR Mutation Test.

About Chlamydia
Chlamydia is the most common bacterial Sexually Transmitted Disease (STD),
with the highest prevalence among youth. Routine screening for chlamydial
infection in young women has been demonstrated to reduce infection rates and
the long-term consequences of untreated disease, as well as lowering the
financial burden on the healthcare system. The Centers for Disease Control and
Prevention (CDC) recommends annual Chlamydia trachomatis screening for all
sexually active females under 25 years old and additional testing for pregnant
women and those with risk factors.

About Gonorrhea
Gonorrhea is the second most commonly reported bacterial STD in the United
States. Infections in males are generally symptomatic, motivating infected
patients to seek evaluation by a clinician for identification and treatment
before the onset of serious complications. Gonococcal infections in women are
often asymptomatic and may not be immediately recognized, which can progress
to Pelvic Inflammatory Disease, tubal scarring, infertility and ectopic
pregnancy. Screening of sexually active women under the age of 25 and those at
high risk for infection is the focus of successful detection programs in the
United States.

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, 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.

All trademarks used or mentioned in this release are protected by law.

For media inquiries please contact:
Bob Purcell
888-545-2443

SOURCE Roche

Website: http://www.roche.com
 
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