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 Diagnostics presented results from their related five-center 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.
"This is an important day for the blood screening community and concludes
a successful effort by Roche Diagnostics, the blood centers and FDA to bring
this important test to market," said Heino von Prondzynski, CEO Division Roche
Diagnostics and Member of the Executive Committee. "Implementation of the
COBAS AmpliScreen HBV test based on PCR (polymerase chain reaction) ensures
that a highly sensitive and robust technology is being used to keep our
precious blood supply safe."
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 centers in the
U.S., 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 centers voluntarily chose to continue using
Roche Diagnostics' test under a cost-recovery IND (Investigational New Drug)
Since conclusion of the clinical trial period in 2004, three additional
"window cases" out of an additional 1 million donated blood units were
identified using the COBAS AmpliScreen HBV Test.
"Memorial Blood Centers is proud to have been one of the first three
centers to use the Roche Hepatitis B blood screening nucleic acid testing
assay," said Jed Gorlin, MD, vice president of medical and quality affairs at
Memorial Blood Centers in Minneapolis. "The study clearly documented the
necessity to be vigilant in continuing to screen the blood supply for
Hepatitis B. The current Hepatitis B surface antigen assays are very
sensitive, but on rare occasions, may still miss small, but potentially
infectious amounts of Hepatitis B."