First FDA-approved laboratory test for quantifying DNA of potentially deadly virus helps physicians manage organ transplant patients on antiviral therapy
INDIANAPOLIS, Sept. 17, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the commercial availability of a new test to assess a patient's viral load of cytomegalovirus (CMV). Physicians use information from the test to help them manage patients who have been diagnosed with CMV disease, specifically patients with an immune system that has been suppressed for solid organ transplantation. The test received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in July 2012.
"With this new test, diagnostic laboratories now have a standardized, FDA-approved option for CMV viral load testing that addresses a key medical need for transplant patients," said Whitney Green, senior vice president, molecular diagnostics, for Roche Diagnostics Corporation. "There has been significant interest in the test from labs and the transplant community since the FDA approval, as it will provide physicians with clinically useful information to help them manage patients with CMV disease."
The real-time polymerase chain reaction (PCR)-based CMV test provides standardization of CMV viral load monitoring with traceability to the WHO International CMV standard. It is designed for use on Roche's fully automated COBAS® AmpliPrep/COBAS® TaqMan® System, an established platform for viral load monitoring of multiple infectious diseases that helps laboratories improve their workflow. The system can be combined with the cobas p 630 Instrument, which provides an integrated pre-analytical primary tube handling solution.
About the test
The first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens, the COBAS AmpliPrep/COBAS TaqMan CMV Test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. In this population, the test can be used to assess virological response to antiviral treatment.
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 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, which is designed to prevent cross-contamination of samples and labs, is included in each test.
CMV is the most common viral infection in solid organ transplant 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, malaise and mild laboratory abnormalities, or can be more serious with involvement of the lung or gastrointestinal tract. Fifty to eighty percent of all people in the U.S. 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 personalized 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. For more information: www.roche.com.
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