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Roche Gets European Marketing Clearance for New HIV-1 Molecular Assay

NEW YORK (GenomeWeb News) – Roche has received the CE-IVD Mark for its new dual-target HIV-1 test allowing it to be used for clinical use throughout the European Union, the firm said today.
The firm’s Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0 simultaneously amplifies and detects two separate regions of the HIV-1genome, which Roche said enables reliable results even when mutations are present. The test also uses real-time PCR to quantify the amount of HIV-1RNA in a patient’s blood.
“Because it is impossible to predict when these mutations will occur, we have designed this test to detect all HIV-1 (Group M and O) strains," Daniel O’Day, president and CEO of Roche Molecular Diagnostics, said in a statement.
Roche noted that the test is the first dual-target test offered on the Cobas AmpliPrep/Cobas TaqMan System.