Roche Diagnostics has received FDA approval for the first two tests which are designed for use with COBAS AmpliScreen System -- the COBAS AmpliScreen HCV Test, version 2.0 and the COBAS AmpliScreen HIV-1 Test, version 1.5. Roche has also received FDA clearance for the COBAS AmpliScreen Data Output Management System (DOMS), a computerized data collection system intended for use with the COBAS AmpliScreen System to collect specimen and test data.
Both Tests utilize Roche's Polymerase Chain Reaction (PCR)-based nucleic acid based technology (NAT) and are qualitative in vitro tests for the direct detection of Hepatitis C (HCV) virus RNA and Human Immunodeficiency virus (HIV-1) RNA in human plasma from donations of whole blood and blood components for transfusion. The Tests are intended for use in screening individual donor samples of human plasma or pools of human plasma comprised of equal aliquots of not more than 24 individual donations.
"We appreciate the efforts by the FDA who approved our Biologics License Applications for these tests in record time," said Heiner Dreismann, President and CEO of Roche Molecular Systems, Inc., the business area within Roche Diagnostics responsible for the research, development and marketing of these newly approved tests. "We are continuing to demonstrate our serious and long-term commitment to this important market segment," he continued.
"With both our COBAS AmpliScreen System and COBAS AmpliScreen HIV-1 and HCV Tests now commercially available, we can rapidly proceed to provide blood banking community customers in the U.S. with further access to our PCR NAT technology," added Martin Madaus, President and CEO, Roche Diagnostics North America.
Since 1999, under Investigational New Drug Applications (INDs), America's Blood Centers have used the COBAS AmpliScreen HCV and HIV-1 tests to screen over 12 million donations in the U.S. NAT demonstrated the ability of the Tests to detect HIV-1 and HCV RNA in donations of blood and blood components during the time between infection and detection known as the "window period." Earlier detection of these viruses can further reduce the potential of infectious blood and blood components from being transfused. The COBAS AmpliScreen tests have identified 3 HIV-1 positive and 43 HCV positive donations that would otherwise have entered the country's blood supply during this three-year study.