The U.S. Food and Drug Administration (FDA) has granted clearance of Roche's Cobas AmpliScreen System. The Cobas AmpliScreen System is intended for use in laboratories testing human plasma specimens, for example to detect Hepatitis C (HCV) and Human Immunodeficiency Virus (HIV-1) viruses. The System automates the sample dilution and pooling procedures as well as the amplification and detection steps for analysis of specimens using the Polymerase Chain Reaction (PCR)-based nucleic acid amplification methods.
"This is a significant milestone for our company's PCR blood screening business," stated Heino von Prondzynski, Head of Roche Diagnostics and a member of Roche's Corporate Executive Committee. "It's extremely rewarding to see the technical, financial and human resources that we have invested for several years in this important market sector being recognized. This will help our customers to offer safer blood screening."
Roche also expects to receive FDA approval of the two PCR-based nucleic acid based technology (NAT) tests for HCV and HIV-1, which are to be used with the Cobas AmpliScreen System. Roche's AmpliScreen blood screening tests for HCV and HIV-1, are already approved for commercial use in Italy, France, Germany, Australia and Switzerland. Roche screens 100 percent of the blood supply in Japan (through its work with the Japanese Red Cross), the Netherlands and the United Kingdom, as well as more than 75 percent of Italy and France's blood donations. The products are also used in other countries where registration is not required. Sales for Roche's blood screening business are on target at 150 million Swiss Francs during 2002.
The Cobas AmpliScreen System, along with Roche's Cobas AmpliScreen HCV Test, and the Cobas AmpliScreen HIV-1 Test, have been used by America's Blood Centers since 1999 under Investigational New Drug Applications (INDs) to screen blood donations for the presence of the HCV and HIV-1 RNA viruses. This network of local, non-profit, community blood centers collects nearly half of the U.S. blood supply and a quarter of the Canadian blood supply.
"We've really seen the difference that NAT testing can make in reducing the window period, or number of days, between the time that a person contracts HIV or HCV and when the viruses can be detected using current FDA-approved serological tests," says Celso Bianco Executive Vice President of America's Blood Centers and an expert on medical issues within the blood banking community. "Roche is to be commended for their ongoing commitment to automating NAT testing as it truly helps improve blood safety," he continued.