Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.
PRNewswire - December 5, 2002
"The COBAS AmpliScreen System FDA clearance is an important milestone for our company's PCR blood screening business. We look forward to receiving FDA approval of the two PCR-based nucleic acid based technology (NAT) assays for HCV and HIV-1 which are to be used with the COBAS AmpliScreen System," said Martin Madaus, President and CEO, Roche Diagnostics North America.
The COBAS AmpliScreen System, along with Roche's COBAS AmpliScreen(TM) HCV Test, version 2.0 and the COBAS AmpliScreen(TM) HIV-1 Test, version 1.5, 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 international 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 MD, 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.
"The FDA approval of Roche's COBAS AmpliScreen System is the first step to providing the blood banking community with yet another commercial option and further access to NAT testing," said Jim MacPherson, Chief Executive Officer of America's Blood Centers. Mr. MacPherson is referring to the fact that this marks the second NAT-based blood testing system to be cleared by the FDA.
About the COBAS AmpliScreen System
"The COBAS AmpliScreen System is a product of original research from Roche Molecular Systems, Inc.," said Heiner Dreismann, President and CEO of this business area of Roche Diagnostics. RMS has made polymerase chain reaction (PCR) the leading nucleic acid amplification technology (NAT) in the world.
The COBAS AmpliScreen System combines a commercially available pipetting/diluting instrument (the Hamilton Microlab AT plus 2 pipettor) and an automated bench top analyzer (Roche's COBAS AMPLICOR(TM) Analyzer) to automate the sample pooling amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The System is designed for use with the COBAS AmpliScreen(TM) HCV Test, version 2.0 and the COBAS AmpliScreen(TM) HIV-1 Test, version 1.5. Both tests are qualitative in vitro tests for the direct detection of Hepatitis C virus RNA and Human Immunodeficiency virus (HIV-1) RNA in human plasma using PCR nucleic acid amplification and nucleic acid hybridization. Roche filed their Biological License Application with the FDA for these two tests earlier this year.
Availability of Roche's AmpliScreen Products Outside of the U.S.
Roche's AmpliScreen blood screening tests for HCV and HIV-1 are already approved for commercial use in Italy, France, Germany, Australia and Switzerland. Poland has approved the COBAS AmpliScreen(TM) HCV Test, version 2.0 for commercial use, and Spain has approved the COBAS AmpliScreen(TM) HIV-1 Test, version 1.5. The products are also used in other countries where registration is not required.
About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-oriented healthcare groups. The company's two core businesses in pharmaceuticals and diagnostics provide innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. The two core businesses achieved a turnover of 13.1 billion Swiss Francs in the 1st half of 2002 and employed about 57,000 employees worldwide. Roche's Diagnostics Division, the world leader in in vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services used by researchers, physicians, patients, hospitals and laboratories worldwide. Roche Diagnostics' North American headquarters are located in Indianapolis, Ind. For further information, please visit Roche's websites at http://www.roche.com and http://www.roche-diagnostics.com .
For more information please contact:
1.Joel Reuter
Roche Diagnostics Corp.
ph: (317) 521-7431
fax: (317) 521-4696
joel.reuter@roche.com
2.Paula Evangelista
Roche Molecular Systems, Inc.
ph: (925) 730-8364
fax: (925) 225-0758
paula.evangelista@roche.com
SOURCE Roche Diagnostics Corp.
Web Site: http://www.roche.com http://www.roche-diagnostics.com
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