Roche Diagnostics' Cobas AmpliScreen HBV Test has been approved by US FDA 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, Roche said.

The approval follows a decisive vote in favour of licensure at an earlier Blood Products Advisory Committee of the FDA in 2004, at which time Roche Diagnostics presented results from their related five-centre clinical study. Roche Diagnostics submitted a Biologics License Application (BLA) to the FDA, for the Cobas AmpliScreen HBV Test to screen plasma samples from donors of whole blood and blood components, source plasma and other living donor organ components.

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) which may have gone undetected by currently licensed HBsAg tests. In these tests, conducted at five blood centres in the US, Roche Diagnostics evaluated 581,790 individual donations in pools of 24.

In addition, Roche Diagnostics presented non-clinical 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. Following the conclusion of the clinical study period, three of the five centres voluntarily chose to continue using Roche Diagnostics' test under a cost-recovery IND (Investigational New Drug) protocol, the release added.