FDA Advisory Committee Overwhelmingly Recommends Approval of Roche's COBAS AmpliScreen Hepatitis B Test for Use in Screening Donated Whole Blood

PLEASANTON, Calif. -- Roche Diagnostics announced that the Blood Products Advisory Committee (BPAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly that the sensitivity and specificity of Roche's COBAS AmpliScreen HBV Test in a mini-pool format supported licensing as a screening test for the detection of Hepatitis B (HBV) in donated whole blood. The advisory committee's 15-1 vote supporting licensure was made July 24th, after Roche Molecular Systems (RMS) presented results from their clinical study at a meeting of the BPAC. The test is the first nucleic acid test designed for screening whole blood for HBV to be accepted for review by the FDA.

In the clinical study, conducted at five blood centers in the United States, Roche Diagnostics evaluated 581,790 individual donations in pools of 24, and identified two HBV "window cases" (cases within the time between infection and when the infection can be detected) which may have gone undetected by currently licensed HBsAg tests.

In addition, Roche 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 surface antigen test. Following the conclusion of the clinical study period, three of the five centers voluntarily chose to continue using Roche's test under a cost-recovery model. Since conclusion of the clinical trial period, three additional "window cases" out of an additional one million donated blood units were discovered using the COBAS AmpliScreen HBV test.

"We are delighted with the committee's recommendation and we commend the committee on its thorough analysis of Roche's extensive clinical data," said Rich Thayer, vice president, blood screening at RMS. "Our studies demonstrate the sensitivity and specificity of our HBV test both as a stand-alone and as used in conjunction with existing screening assays, enabling blood centers to further improve the safety of the blood and blood products used in a variety of therapeutic applications. Ultimately, we feel that blood transfusion recipients will directly benefit from the committee's recommendation today."

Roche Molecular Systems submitted a Biologics License Application (BLA) to the FDA in December 2003 for the COBAS AmpliScreen HBV Test to screen plasma samples from donors of whole blood and blood components, source plasma and other living donors.

Source: Roche Diagnostics

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