PLEASANTON, Calif.,
June 4, 2015 /PRNewswire/
-- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the
US Food and Drug Administration (FDA) has provided 510(k) clearance
for the cobas® HSV 1 and 2 Test for the direct detection and
differentiation of HSV-1 and HSV-2 DNA in anogenital specimens from
symptomatic patients. 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. This can help labs reduce
costs, improve turnaround time and enable staff to spend more time
on other critical tasks.
"Accurate diagnosis of genital herpes infections, whether caused
by HSV-1 or HSV-2, has important personal and public health
implications," said Edward Hook III,
MD, Director, Division of Infectious Diseases and Professor of
Medicine, Epidemiology and Microbiology, University of
Alabama. "Many genital herpes infections present with non-
'classical' genital lesions. Culture is clearly inferior to
nucleic acid amplification testing and use of polymerase chain
reaction (PCR)-based tests will lead to improved etiologic
diagnosis and better patient care."
"The addition of the cobas® HSV 1 and 2 Test expands the
menu for the cobas® 4800 System, enabling labs to experience
increased efficiency with innovative testing solutions," said
Paul Brown, head of Roche Molecular
Diagnostics. "This highly sensitive and specific new test for the
detection of herpes simplex virus delivers reliable results to
physicians for optimal patient treatment and clinical management
decisions."
Treatment guidelines cite the importance of sensitivity for HSV
detection, and that PCR has demonstrated superior clinical
performance to culture techniques1-2. Using one of
the fastest, most advanced real-time PCR detection methods
available today, the cobas® HSV 1 and 2 Test
offers accurate and reliable results through the use of simple and
reliable sample collection technology and automated
processing. The test is performed on the cobas® 4800
System, currently the only FDA-cleared system which offers the
flexibility to run sexually transmitted infection and
healthcare-associated infection tests, in the same run, on a single
platform.
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 presence of 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 in the U.S. currently
includes the cobas® CT/NG Test (Chlamydia
trachomatis/Neisseria gonorrhoeae), cobas® HPV Test,
cobas® MRSA/SA Test, cobas® Cdiff Test, , cobas® BRAF
V600 Mutation Test, cobas® EGFR Mutation Test and
cobas® KRAS Mutation Test.
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, immunology, infectious
diseases, ophthalmology 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 diagnostics
that enable tangible improvements in the health, quality of life
and survival of patients. Founded in 1896, Roche has been making
important contributions to global health for more than a century.
Twenty-four medicines developed by Roche are included in the World
Health Organization Model Lists of Essential Medicines, among them
life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide,
invested 8.9 billion Swiss francs in
R&D and posted sales of 47.5 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 roche.com.
- Patel et al. 2010 European guidelines for the management of
genital herpes.
- Workowski et al. 2010 Sexually Transmitted Diseases Treatment
Guideline, MMWR 59
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SOURCE Roche