The US Food and Drug Administration (FDA) has approved Roche’s cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients.
The test standardizes CMV testing for both solid organ and hematopoietic stem cell transplant recipients. It can be used to monitor CMV treatment in all types of transplant patients.
It is designed for use on the automated COBAS AmpliPrep/COBAS TaqMan System, a platform for viral load monitoring of several infectious diseases.
The COBAS AmpliPrep/COBAS TaqMan CMV Test is now available to monitor CMV treatment in all types of transplant patients in the US.
It is an in vitro nucleic acid amplification test for the quantitative measurement of CMV DNA.
The test supports in the management of solid-organ transplant and hematopoietic stem-cell transplant recipients who are undergoing anti-CMV therapy.
Roche said the test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products.
It can be used on the Cobas AmpliPrep/Cobas TaqMan system, a platform for viral load monitoring of multiple infectious diseases.
The system aggregates 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.
Roche molecular diagnostics head Uwe Oberlaender said: "Cytomegalovirus is the most important viral infection in hematopoietic stem cell transplant patients.
"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."
Image: The administration and R&D buildings, Roche Diagnostics Ltd, Rotkreuz. Photo: courtesy of F. Hoffmann-La Roche Ltd.