- CMV is the most common and serious viral infection in transplant patients
- The cobas® CMV test provides reliable, reproducible, high-quality results for clinical
decision-making
- CMV viral load testing is used to assess how solid organ and hematopoietic stem cell transplant patients on
therapy are responding to treatment
PLEASANTON, California, June 21, 2017 /PRNewswire/ -- Roche
(SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of cobas® CMV (cytomegalovirus) for use on the
automated cobas® 4800 System in countries accepting the CE mark. Health care professionals use the CMV test to
assess how solid organ and hematopoietic stem cell transplant patients on therapy are responding to treatment. The test is
standardised to the 1st WHO International Standard for improving harmonisation in CMV testing results across hospital
institutions.
This new molecular diagnostic assay increases the available menu for low to medium throughput laboratories on the cobas 4800
System, enabling consolidation of testing, improving efficiency and flexibility to deliver results for rapid clinical
decisions.
"Patients, caregivers and laboratories can rely on the standardized results from the cobas CMV test and compare these results
across institutions to increase the quality of care for transplant patients infected with CMV," said Uwe
Oberlaender, head of Roche Molecular Diagnostics. "With this addition, the cobas 4800 System now has a menu of 13
high medical value IVD assays, making it the ideal solution for a highly efficient laboratory."
In addition to the CMV assay, Roche has CE-IVD viral load tests for HIV-1, HCV, HCV genotyping (GT), and HBV for the cobas
4800 System, representing a complete portfolio of viral load monitoring tests.
About the cobas CMV viral load test for use on the cobas 4800 System
cobas CMV is a real-time PCR (polymerase chain reaction) test designed to offer an expanded linear range from 34.5
IU/mL to 1E+07 IU/mL with robust coverage across genotypes. The test minimizes variability and complexity in testing offering an
alternative to lab-developed tests (LDTs) reducing workload and alleviating risk for laboratories. The clinically validated
cobas CMV Test provides reproducible, high-quality results for clinical decision-making to support the goal of result
standardization across institutions.
The fully automated cobas CMV Test can be run on the cobas 4800 System, streamlining workflow while increasing flexibility for
patient sample management.
About Cytomegalovirus (CMV)
CMV is the most common and serious viral infection in transplant patients. The virus can be transmitted through the
donor organ, resulting in CMV infection and leading to the development of CMV disease, or can be reactivated in transplant
recipients with previous CMV infection. CMV disease in hematopoietic transplant recipients can cause life-threatening damage to
many organs including the lung, liver, kidney, gastrointestinal tract and eye. The prevalence varies in different geographic
regions with between 40 and 100 percent of the adult population are infected with CMV.[1] 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. If a person becomes immunosuppressed, as happens in transplantation, the virus can become reactivated and cause
symptomatic disease.
About the cobas 4800 System
The cobas 4800 System offers improved automation of nucleic acid purification, PCR (polymerase chain reaction) set-up
and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system now has a comprehensive
test menu including the cobas HIV-1 Test, cobas HCV Test, cobas HBV Test, cobas CMV Test, cobas HCV Genotyping Test, cobas
MRSA/SA Test, cobas HSV 1 and 2 Test, cobas C.diff Test, cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600
Mutation Test, cobas EGFR Mutation Test, and the cobas KRAS Mutation Test.
For more information about the cobas 4800 System, please visit 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. Twenty-nine 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. Roche has been recognised as the Group Leader
in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones
Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in
2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D
and posted sales of CHF 50.6 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.
[1] Vilibic-Cavlek et al. Prevalence and dynamics of cytomegalovirus infection among patients undergoing
chronic hemodialysis. Indian J Nephrol. 2015 Mar-Apr; 25(2): 95–98.
For media inquiries please contact:
Todd Siesky
Roche Molecular Diagnostics
1-888-545-2443