June 21, 2017
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.
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. 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.
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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.