www.fdanews.com/articles/176802-fda-approves-roches-cytomegalovirus-test
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FDA Approves Roche’s Cytomegalovirus Test
May 25, 2016
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