NEW YORK (GenomeWeb) – Roche today announced that that the US Food and Drug Administration has approved the firm's cytomegalovirus (CMV) test for use with hematopoietic stem cell transplant recipients.
The real-time PCR-based Cobas AmpliPrep/Cobas TaqMan CMV test is the first to received FDA approval for that use case and is now available for all transplant patients, Roche said in a statement. The firm added that the test is already the leading in vitro diagnostic for solid organ transplant recipients in the US.
The CMV assay assists in the management of transplant recipients undergoing anti-CMV therapy. It detects viral DNA to help assess virological response to treatment, and runs on Roche's Cobas AmpliPrep/Cobas TaqMan system.
"Cytomegalovirus is the most important viral infection in hematopoietic stem cell transplant patients," Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement. "With this new FDA approval, hematopoietic stem cell transplant clinicians and patients have another tool to help fight CMV."
The Cobas CMV assay also conforms to the World Health Organization International Standard, enabling labs worldwide to compare results.
The FDA awarded Roche premarket approval for the test in 2012. In 2014, Roche landed CE marking for its CMV viral load assay for the Cobas 6800/8800 PCR platforms.