FDA News

FDA approves first CMV test for hematopoietic stem cell transplant recipients

The FDA approved the first in vitro diagnostic test used to monitor cytomegalovirus treatment in hematopoietic stem cell transplant recipients, according to a press release.

With this approval, the COBAS AmpliPrep/COBAS TaqMan CMV test (Roche) is now available to help manage anti-cytomegalovirus (CMV) therapy for all types of transplant patients in the United States, the release said. It is not intended to be used as a screening device for CMV DNA in blood or blood products. The CMV test is designed for use on the COBAS AmpliPrep/COBAS TaqMan System, a platform used to monitor multiple infectious diseases such as hepatitis B, hepatitis C and HIV.

Approximately 50% to 80% of all people living in the United States are infected with CMV, according to the release. After infection, the virus remains latent in a patient’s body for life. However, the virus can be reactivated, causing symptomatic disease, when an infected patient becomes immunosuppressed. In hematopoietic transplant recipients, the virus can cause severe damage to multiple organs including the lung, liver, kidney, gastrointestinal tract and eye.

“Cytomegalovirus is the most important viral infection in hematopoietic stem cell transplant patients,” Uwe Oberlaender, PhD, head of Roche Molecular Diagnostics, said in the release. “With this new FDA approval, hematopoietic stem cell transplant clinicians and patients have another tool to help fight CMV.”

Disclosure: Oberlaender is an employee of Roche.

The FDA approved the first in vitro diagnostic test used to monitor cytomegalovirus treatment in hematopoietic stem cell transplant recipients, according to a press release.

With this approval, the COBAS AmpliPrep/COBAS TaqMan CMV test (Roche) is now available to help manage anti-cytomegalovirus (CMV) therapy for all types of transplant patients in the United States, the release said. It is not intended to be used as a screening device for CMV DNA in blood or blood products. The CMV test is designed for use on the COBAS AmpliPrep/COBAS TaqMan System, a platform used to monitor multiple infectious diseases such as hepatitis B, hepatitis C and HIV.

Approximately 50% to 80% of all people living in the United States are infected with CMV, according to the release. After infection, the virus remains latent in a patient’s body for life. However, the virus can be reactivated, causing symptomatic disease, when an infected patient becomes immunosuppressed. In hematopoietic transplant recipients, the virus can cause severe damage to multiple organs including the lung, liver, kidney, gastrointestinal tract and eye.

“Cytomegalovirus is the most important viral infection in hematopoietic stem cell transplant patients,” Uwe Oberlaender, PhD, head of Roche Molecular Diagnostics, said in the release. “With this new FDA approval, hematopoietic stem cell transplant clinicians and patients have another tool to help fight CMV.”

Disclosure: Oberlaender is an employee of Roche.