FDA grants approval to Roche’s cytomegalovirus test

25 May 2016 (Last Updated May 25th, 2016 18:30)

The US Food and Drug Administration (FDA) has approved the usage of Roche's cytomegalovirus (CMV) test for hematopoietic stem cell transplant recipients

CMV

The US Food and Drug Administration (FDA) has approved the usage of Roche's cytomegalovirus (CMV) test for hematopoietic stem cell transplant recipients.

Following the approval, the COBAS AmpliPrep / COBAS TaqMan CMV Test is adopted to monitor CMV treatment in all types of transplant patients in the US.

It is the first in-vitro nucleic acid amplification test compliant to the World Health Organisation (WHO) standards and is used for the quantitative measurement of cytomegalovirus (CMV) DNA.

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."

CMV is a critical infection commonly affecting transplant patients which can spread through the donor organ, it can also occur due to the reactivation of the virus in transplant recipients already infected with CMV virus.

"With this new FDA approval, hematopoietic stem cell transplant clinicians and patients have another tool to help fight CMV."

The CMV test assists the management of solid-organ transplant and hematopoietic stem-cell transplant recipients that have been administered with the anti-CMV therapy.

The serial DNA measurements can be used to test the virological response to antiviral treatment, the result of the test is interpreted within the scope of all relevant clinical and laboratory findings.

The COBAS AmpliPrep / COBAS TaqMan System combines the COBAS AmpliPrep Instrument to facilitate an automated sample preparation and the COBAS TaqMan Analyzer or the smaller COBAS TaqMan 48 Analyzer offers an automated real-time detection of polymerase chain reaction (PCR).

However the COBAS AmpliPrep / COBAS TaqMan CMV Test cannot be used as a screening test to detect the presence of CMV DNA in blood or blood products.


Image: Histopathology of lung displays CMV infection. Photo: courtesy of CDC/Dr. Edwin P. Ewing, Jr.