Roche announces launch of the cobas® HSV 1 and 2 Test for herpes simplex virus
in markets accepting the CE mark
PLEASANTON, California, Jan. 8, 2014
-- New test expands menu for sexually transmitted infections testing on the
cobas® 4800 System
PLEASANTON, California, Jan. 8,2014 /PRNewswire/ -- Roche (SIX: RO, ROG;
OTCQX: RHHBY) announced today the CE-IVD launch of the cobas® HSV 1 and 2 Test
for the direct detection of HSV-1 and HSV-2 DNA in anogenital specimens. With
dual target detection and automation, the cobas® HSV 1 and 2 Test provides
laboratories with the capability to report up to 94 results in significantly
less time than traditional methods and provides a simplified workflow for
sample handling in the laboratory.
Treatment guidelines cite the importance of sensitivity for HSV detection, and
that Polymerase Chain Reaction (PCR) has demonstrated superior clinical
performance to culture techniques ^1 .Using one of the fastest, most advanced
real-time PCR detection available today, the cobas® HSV 1 and 2 Test offers
accurate and reliable results through the use of simple and reliablesample
collection technology and automatedprocessing.
"Clinical management of patients infected with HSV type 1 or type 2 requires a
clear understanding of the virus, and as resistance to anti-viral agents
continues to evolve, there are increasing concerns about the plasticity of the
HSV genome," said Dr. Raj Patel FRCP, Consultant GUM/HIV Physician and Senior
Lecturer, University of Southampton, UK."The innovative dual target
approachof cobas® HSV 1 and 2 Test allows the detection of two distinct,
conserved regions of the HSV genome, providing accurate detection of the virus
and peace of mind when managing patients."
"The cobas® HSV 1 and 2 Test provides labs with a highly sensitive and
specific test for the detection of herpes simplex virus," said Paul Brown,
head of Roche Molecular Diagnostics. "This not only allows for optimal patient
treatment and management decisions, but it also expands the menu of our cobas®
4800 System which enables labs to experience increased efficiency."
The test is performed on the cobas® 4800 System, currently the only CE-IVD
marked system which offers the flexibility to run sexually transmitted
infection and HAI tests, in the same run, on a single platform. The
streamlined workflow can help labs reduce costs, improve turnaround time and
enable staff to spend time on other critical tasks.
About Herpes Simplex Virus Clinical presentation for Herpes Simplex Virus
infection is variable, and frequently signs and symptoms can be easily
confused with other conditions. Most HSV-1 infections occur early in childhood
and often go unrecognized, while HSV-2 infection rates remain low until the
age of sexual maturity. Approximately 70 to 90% of patients with reactive
serology for HSV-2 have not been diagnosed with genital herpes. Laboratory
confirmation is recommended for all patients with suspected genital herpes,
using methods that directly demonstrate the virus in genital specimens. The
type of HSV a patient is infected with has an impact on management and
treatment decisions, as HSV-2 recurrence is considerably higher than that of
HSV-1. Molecular testing by PCR is the most sensitive method of direct
detection for HSV-1 and HSV-2.
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 expanding system menu currently
includes the cobas® MRSA/SA Test, cobas® CT/NG Test (chlamydia/gonorrhea),
cobas® HPV Test, cobas® BRAF V600 Mutation Test and the cobas® EGFR Mutation
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 personalised
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 .
1. Patel et al. 2010 European guidelines for the management of genital herpes.
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