Roche has announced the United States Food and Drug Administration (FDA) approval of the first cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients. With this approval, the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is available for monitoring CMV treatment in all types of transplant patients in the USA. The test was the first in vitro diagnostic test conforming to the WHO International Standard, making it possible for laboratories worldwide to obtain comparable results when testing for CMV and it is now the most commonly used in vitro diagnostic test for CMV solid organ transplant recipients in the USA.
"Cytomegalovirus is the most important viral infection in hematopoietic stem cell transplant patients," said Uwe Oberlaender, Head of Roche Molecular Diagnostics. "With this new FDA approval, hematopoietic stem cell transplant clinicians and patients have another tool to help fight CMV. As the world's leading molecular virology testing company, Roche is proud to offer a WHO-standardized test to improve care for transplant recipients."
Roche's standardized real-time polymerase chain reaction (PCR)-based CMV test is designed for use on the automated COBAS® AmpliPrep/COBAS® TaqMan® System, an established platform for viral load monitoring of multiple infectious diseases.
About the test
The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is an in vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA.
The test is intended for use as an aid in the management of solid-organ transplant and hematopoietic stem-cell transplant recipients who are undergoing anti-CMV therapy. In this population, serial DNA measurements can be used to assess virological response to antiviral treatment. The results from the test must be interpreted within the context of all relevant clinical and laboratory findings. 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. The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products.