FDA Approves Roche’s Cytomegalovirus Test

The FDA has approved Roche’s COBAS AmpliPrep/COBAS TaqMan cytomegalovirus test for use in hematopoietic stem cell transplant recipients.

Designed for use on the company’s COBAS AmpliPrep/COBAS TaqMan platform, the in vitro test is intended to facilitate the management of solid-organ transplant and hematopoietic stem-cell transplant recipients undergoing anti-CMV therapy.

The CMV test is the first to nab FDA approval for this indication, according to the company. — Anisa Jibrell