Roche Gains FDA Approval For Cytomegalovirus Test

Law360, Washington (July 5, 2012, 5:02 PM EDT) -- The U.S. Food and Drug Administration on Thursday approved a Roche Holding AG DNA test to track levels of a common virus that can cause serious side effects in solid organ transplant patients, saying the test will enhance transplant patient care.

Roche's COBAS AmpliPrep/COBAS TaqMan CMV Test tracks cytomegalovirus loads in patients' blood to determine the efficacy of anti-CMV treatments. The virus can cause pneumonia, colitis or other serious diseases in heart, lung, kidney, pancreas and small intestine transplant patients as well as other immunocompromised individuals,...
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