-
New tests on cobas 6800/8800
systems provide clinicians information to help speed treatment and
reduce the spread of infection
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Rising challenge of drug
resistance compounds the tuberculosis global health
crisis
-
Mycobacteria test menu allows
detection of tuberculosis, drug resistant tuberculosis and
nontuberculous mycobacteria infections from single patient
sample
Basel, 14 May 2019 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced the CE-IVD launch of the cobas® MTB-RIF/INH
test to detect resistance to antibiotics within tuberculosis DNA.
This assay is part of the mycobacteria test menu that includes the
cobas® MTB and cobas® MAI tests for use on the cobas® 6800/8800
Systems. This continues the expansion of the testing menu on the
cobas 6800/8800 Systems, supporting true consolidation and
efficient testing.
Tuberculosis is the leading cause of infectious disease deaths
worldwide.1,2 The rising
challenge of drug resistance compounds the tuberculosis global
health crisis. The high sensitivity of the cobas MTB test enables
increased detection of tuberculosis in challenging smear-negative
samples. A complete mycobacteria test menu provides the flexibility
to detect a combination of tuberculosis, drug resistant
tuberculosis and nontuberculous mycobacteria infections from a
single patient sample. This provides important information for
patient care decisions.
"With the addition of cobas MTB-RIF/INH to the mycobacteria test
menu, we are able to equip laboratories with flexible, sensitive
solutions to best help them diagnose tuberculosis, which is
difficult to detect," said Michael Heuer, CEO Roche Diagnostics.
"This menu approach not only aids healthcare providers in
addressing the global health challenge that tuberculosis presents,
but also provides clinicians the valuable information they need to
properly diagnose these respiratory infections to speed treatment
and reduce the spread of infection."
The fully automated cobas 6800/8800 Systems offer the fastest time
to results with the highest throughput and the longest walk-away
time available among automated molecular platforms, providing
laboratories with improved operating efficiency and the flexibility
to adapt to changing testing demands.
About the Mycobacteria assay
portfolio
The cobas MTB test enables the detection of Mycobacterium
tuberculosis complex (MTBC) DNA, while the cobas MAI test enables
the direct detection and differentiation of Mycobacterium avium and
Mycobacterium intracellulare DNA in symptomatic patients. The cobas
MTB-RIF/INH test detects mutations associated with resistance to
antibiotics rifampicin and isoniazid within tuberculosis DNA. All
mycobacteria tests have been validated for use with raw sputum,
sputum sediment and bronchoalveolar lavage (BAL) sediment
samples
About Mycobacterium tuberculosis
The World Health Organization (WHO) estimates that about 1.7
billion people are infected with tuberculosis, with an estimated 10
million new active tuberculosis infections and 1.6 million deaths
in 2017.1 This includes approximately 920,000 tuberculosis
infections in people living with HIV/AIDS and 300,000 deaths in
this population.1
About Mycobacterium intracellulare and
Mycobacterium avium
Mycobacterium avium and Mycobacterium intracellulare are two
closely related, distinct species of nontuberculous mycobacteria
(NTM), which comprise the M. avium-intracellulare complex (MAC),
and may also be grouped together as M. avium intracellulare (MAI).
Although NTM can colonize body surfaces and secretions without
causing disease, they have been associated with four distinct
clinical syndromes; progressive pulmonary disease, disseminated
disease in severely immunocompromised patients, and skin and soft
tissue infection usually as a consequence of direct
inoculation.3
About the cobas 6800/8800 Systems
Since 2014, the cobas 6800 and cobas 8800 Systems
have established the new standard for routine molecular testing by
delivering fully integrated, automated solutions that serve the
areas of viral load monitoring, donor screening, sexual health and
microbiology. Based on Nobel prize-winning PCR technology, the
systems deliver proven performance with full automation, increased
throughput, fast turnaround time and complete track connectivity
validated for molecular testing, providing users with greater
flexibility to consolidate their IVD and LDT testing to a single
system while increasing overall workflow efficiencies.
The systems provide up to 96 results in about 3 hours and a total
of 864 results for the cobas 6800 System and 1,824 results for the
cobas 8800 System from an eight-hour shift. Both make it possible
for labs to perform up to three tests in the same run with no
pre-sorting required. The systems also enable up to eight hours
(cobas 6800 System) and four hours (cobas 8800 System) of walk-away
time with minimal user interaction.
For more information about the systems, please visit
www.cobas68008800.com or http://molecular.roche.com.
About Roche
Roche is a
global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths
of pharmaceuticals and diagnostics under one roof have made Roche
the leader in personalised healthcare - a strategy that aims to fit
the right treatment to each patient in the best way
possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to
improve patient access to medical innovations by working with
all relevant stakeholders. Thirty medicines developed by Roche are
included in the World Health Organization Model Lists of Essential
Medicines, among them life-saving antibiotics, antimalarials and
cancer medicines. Moreover, for the tenth consecutive year, Roche
has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices
(DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of CHF 56.8 billion. 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.
References
[1] World Health
Organization. Global tuberculosis report 2018. Geneva, Switzerland;
WHO, 2018.
[2] Centers for Disease Control and Prevention. Mycobacterium bovis
(Bovine Tuberculosis) in Humans, in Centers for Disease Control and
Prevention Fact Sheets D.o.T. Elimination, Editor. 2011. p.
September 9, 2011.
[3] Griffith DE, Aksamit T, Brown-Elliott BA, et al. An official
ATS/IDSA statement: diagnosis, treatment, and prevention of
nontuberculous mycobacterial diseases. AmericanJ Respir Crit Care
Med. 2007;175:367-416.
Roche Group Media
Relations
Phone: +41 61 688 8888 / e-mail:
media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
20190514_cobasMTB_EN