INDIANAPOLIS, Dec. 23 /PRNewswire/ -- Following recent news of the U.S. Food and Drug Administration's (FDA) clearance of Roche Diagnostics' COBAS AmpliScreen System for the blood banking industry, Roche is now pleased to announce FDA approval of the first two tests which are designed for use with this 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.
About HCV and HIV-1
Hepatitis C Virus is considered to be the principal etiologic agent responsible for 90-95 percent of the cases of post-transfusion non-A and non-B hepatitis(1). HCV is a single-stranded, positive sense RNA virus with a genome of approximately 10,000 nucleotides coding for 3,000 amino acids.(1) As a blood-borne virus, HCV can be transmitted by blood and blood products. HCV affects more than 170 million people worldwide with approximately 4 million of those located in the United States.(2),(3)
HIV-1 is the etiologic agent of Acquired Immunodeficiency Syndrome (AIDS).(4) HIV-1 infection can be transmitted by sexual contact, exposure to infected blood or blood products, or by an infected mother to the fetus.(5) There are 42 million people living with HIV-AIDS worldewide, with more than 790,000 cases of AIDS having been reported in the United States since 1981, and as many as 900,000 Americans who may be infected with HIV at this time.(6),(7)
Roche's Commitment to the Blood Screening Marketplace
Roche is committed to a leadership role in the blood screening arena, helping to make the world's blood supply safer through innovative and cost- effective products using PCR NAT technology. The Company's COBAS AmpliScreen blood screening tests for HCV and HIV-1 are approved for commercial use in Italy, France, Germany, Australia, Switzerland, and now in the U.S. Poland has approved the COBAS AmpliScreen HCV Test, version 2.0 for commercial use, and Spain has approved the COBAS AmpliScreen HIV-1 Test, version 1.5. Roche tests screen 100 percent of the blood supply in Japan (through its work with the Japanese Red Cross), Canada (under an Investigational Testing agreement approved by Health Canada), the Netherlands and the United Kingdom, as well as more than 75 percent of Italy and France's blood donations. These products are also used in other countries where registration is not required.
Roche is also in clinical trails in the U.S., under an Investigational New Drug Application (IND), for evaluating the safety and efficacy of a PCR NAT- based test for the Hepatitis B virus (HBV) for screening blood donations. Roche announced the start of comprehensive clinical trials of its COBAS AmpliScreen HBV Test in August 2002. Two HBV window cases have already been identified during this trial.
The Japanese Red Cross (JRC) has been using Roche's automated AmpliNAT system since February 2000 to screen for HBV in their blood donations. This system was developed to meet the needs of the JRC to screen 5 million donations each year. The AmpliNAT test is a triplex assay capable of simultaneously screening HBV, HCV and HIV viral material.
The Company is also aggressively working on developing a PCR NAT-based test for screening donated blood for the presence of the West Nile virus, and believes it will have an assay ready to meet the FDA's call for assays by the second quarter of 2003.
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, IN. For further information, please visit Roche's websites at www.roche.com and www.roche-diagnostics.com
(1) Choo, Q-L, Weiner, A.J., Overby, L.R. et al. 1990. Hepatitis C Virus:
The major causative agent of viral non-b hepatitis. British Medical
(2) Who Web site, "Hepatitis C" www.who.int
(3) NIH Web site, "Hepatitis C"
(4) Gallo, R.C., Salahuddin, S.Z., Popovic, M., et al. 1984. Frequent
detection and isolation of cytopathic retroviruses (HTLV-III) from
patients with AIDS and at-risk for AIDS. Science. 224:500-502.
(5) Curran, J.W., Jaffe, H.W., Hardy, A.M., et al. 1988. Epidemiology of
HIV-1 Infection and AIDS in the United States. Science. 239:610-616.
(6) Who Web site "HIV" www.who.int/hiv/en/
(7) NIH Web site "HIV" www.niaid.nih.gov/factsheets/hivinf.htm
For more information please contact:
Roche Diagnostics Corporation
Ph: (317) 521-7431
Fax: (317) 521-4696
Roche Molecular Systems, Inc.
Ph: (925) 730-8364
Fax: (925) 225-0758
SOURCE Roche Diagnostics Corporation
CO: Roche Diagnostics Corporation; U.S. Food and Drug Administration
ST: Indiana, Switzerland
12/23/2002 14:08 EST
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