FDAnews Device Daily Bulletin

Roche Molecular Systems is preparing a September launch for the first FDA-approved DNA test to measure viral load of cytomegalovirus (CMV) in solid organ transplant patients undergoing antiviral treatment. The upcoming U.S. launch follows the COBAS AmpliPrep/COBASTaqMan CMV test’s 2011 debut in the EU, where it was CE marked for distribution, Beverley Goede, senior international HIV product manager for Roche Molecular Diagnostics, said. It is also available in parts of Latin America and the Asia-Pacific region, she said.
Devices & Diagnostics Letter