Roche received Health Canada approval for Cytomegalovirus quantitative viral
Health Canada approved the first DNA CMV test to be standardized to the WHO
International Standard for CMV quantitation. This first CMV test provides
clinical value to help clinicians manage solid organ transplant patients on
LAVAL, QC, Nov. 8, 2012 /CNW Telbec/ - Roche (SIX: RO ROG) (OTCQX: RHHBY)
announced today that it has received approval from Health Canada for a new
test to assess a patient's viral load of cytomegalovirus (CMV). The fully
automated COBAS® AmpliPrep / COBAS® TaqMan® CMV Test is the first Health
Canada approved test to be standardized to the WHO International Standard for
use in quantifying CMV DNA in human plasma specimens. Clinicians use CMV DNA
viral load information from the test to help manage patients who have been
diagnosed with CMV disease, specifically patients whose immune system has been
suppressed for solid organ transplantation.
"The first CMV test is a great clinical innovation that will definitely
improve patient care for solid organ transplant recipients'', said Ian
Parfrement, President & General Manager of Roche Diagnostics Canada. "We are
proud to offer a Health Canada approved test that is standardized and
automated CMV viral load testing that improves laboratory's workflow''.
About the test
The COBAS® AmpliPrep / COBAS® TaqMan® CMV Test is intended to be used in
conjunction with clinical presentation and other laboratory markers in the
management of CMV infection in patients at risk for CMV disease. In this
population, the test can be used to assess response to antiviral treatment.
The test is traceable to the first WHO International Standard for Human
Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162) and
reliably monitors cytomegalovirus (CMV) infections.
About the COBAS® AmpliPrep / COBAS® TaqMan® System
Roche's fully automated COBAS AmpliPrep/COBAS TaqMan® System combines the
COBAS AmpliPrep Instrument for automated sample preparation and the COBAS
TaqMan® Analyzer or the smaller COBAS( )TaqMan® 48 Analyzer for automated
real-time PCR amplification and detection. The COBAS AmpliPrep/COBAS TaqMan®
System has parallel processing with other key molecular diagnostics assays
targeting medically relevant diseases (Hepatitis B virus, Hepatitis C virus,
and Human Immunodeficiency Virus). Roche's AmpErase® enzyme is also included
in each test and is designed to prevent carryover contamination by destroying
any amplicon previously generated.
CMV is the most common and important viral infection in solid organ transplant
(SOT) recipients. The virus can be transmitted through the donor organ,
resulting in CMV infection and leading to the development of CMV disease, or
can occur by reactivation of the virus in transplant recipients with previous
CMV infection. CMV disease in transplant recipients may be similar to
infectious mononucleosis with fever or can be more serious with involvement of
the lung or gastrointestinal tract. Between 50 - 80% of all people in Canada
become infected with CMV. Although healthy persons usually have few symptoms
at the time of initial infection, after infection the virus remains in a
latent state in the body for the rest of a person's life. The virus can then
be transmitted and cause infection through organ donation, or latent virus in
the transplant recipient can become reactivated and cause symptomatic disease.
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 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 2011, Roche had over
80'000 employees worldwide and invested over 8 billion Swiss francs in R&D.
The Group posted sales of 42.5 billion Swiss francs. Genentech, United States,
is a wholly owned member of the Roche Group. Roche has a majority stake in
Chugai Pharmaceutical, Japan. Roche Canada was founded in 1931. The company
employs approximately 900 people across the country, with its pharmaceuticals
head office located in Mississauga, Ontario and diagnostics division based in
Laval, Quebec. Roche Canada is actively involved in local communities,
investing in charitable organizations and partnering with healthcare
institutions across the country. For more information, visit
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SOURCE: Roche Diagnostics
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-0- Nov/08/2012 22:01 GMT
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