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Roche receives CE mark for CMV viral load testing on cobas® 4800 System

 

  • 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

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, highquality results for clinical decisionmaking 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.

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 ro

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.