FDA Approves Roche's Cobas AmpliScreen Hepatitis B Test

The FDA has approved Roche Diagnostics' Cobas AmpliScreen HBV Test for use in a mini-pool format as a screening test for the detection of hepatitis B (HBV) in donated whole blood, blood components, source plasma and other living donors.

The test is the first nucleic acid test designed for screening whole blood for HBV to be approved by the FDA, the company said. The approval follows a decisive vote in favor of licensure at an earlier Blood Products Advisory Committee of the FDA in 2004, at which time Roche presented results from its related five-center clinical study.

In the clinical study, the Cobas AmpliScreen HBV identified two HBV "window cases" -- cases within the time between infection and detection of infection by antigen tests - that may have gone undetected by currently licensed hepatitis B surface antigen tests. In these tests, conducted at five blood centers in the U.S., Roche evaluated 581,790 individual donations in pools of 24.

In addition, Roche presented nonclinical study data illustrating that the Cobas AmpliScreen HBV Test reduced the window period by an average of 17 days in 40 seroconversion panels when compared to the currently implemented hepatitis B surface antigen test.