Roche received Health Canada approval for Cytomegalovirus quantitative viral load test

Roche received Health Canada approval for Cytomegalovirus quantitative viral 
load test 
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 
antiviral therapy 
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. 
About Cytomegalovirus 
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. 
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, 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 
All trademarks used or mentioned in this release are legally protected by law. 
Mélanie Lussier Communications Tel. : 450686-3137 
SOURCE: Roche Diagnostics 
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CO: Roche Diagnostics
ST: Quebec
-0- Nov/08/2012 22:01 GMT
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