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March 16, 2005
INDIANAPOLIS /PRNewswire/ -- Today, Roche Diagnostics announced that the United States Food and Drug Administration (FDA) approved its COBAS AmpliScreen HIV-1 and Hepatitis C (HCV) Tests to screen cadaveric organ and tissue donations. The expanded claim for screening blood samples from these donors is in addition to testing whole blood, source plasma and potential living organ donors.
Tissues from cadaveric sources such as skin, bone, and ligaments are used in approximately 1 million medical procedures per year1. These tissues can transmit the same viral infections as blood, and the products from a single tissue donation may be transplanted to an average of 502, or as many as 100 patients.
"This is a great day for tissue and organ banks worldwide, and a great day for patients awaiting much-needed transplants," says Heino von Prondzynski, CEO Division Roche Diagnostics and Member of the Executive Committee. "The sensitivity and specificity of our tests as both a stand-alone and as used in conjunction with existing screening assays, enable tissue banks to further improve the safety of products used in a variety of therapeutic applications. Ultimately, we feel that transplant recipients will directly benefit from the agency's approval today."
Roche Diagnostics' tests have the potential to help detect and thereby prevent transmission of HIV-1 and HCV, making the blood and tissue supply safer, sooner. In a recent documented case, a single antibody-negative donor in October 2000 donated 91 tissues and organs. Nucleic acid testing (NAT), as used in the COBAS AmpliScreen HIV-1 and HCV Tests, performed after donation and transplantation, found the donor to be HCV positive. Eight recipients were identified with HCV3.
Roche Diagnostics' blood and tissue screening tests are based on the company's patented and highly sensitive polymerase chain reaction technology (PCR), which has become the global standard for fast and reliable replication of minute amounts of genetic material to detectable levels. PCR enables detection of the genetic material of infectious agents directly; making it possible to detect infections earlier in the infection cycle than with immunoassays, often before the person making the donation shows any symptoms of disease. Currently, most tissue donors are tested using enzyme immunoassays, which detect antibodies to the target virus. Immunoassay screening technologies, in contrast to nucleic acid testing, detect antigens or antibodies that appear in the body later in the infection cycle. Nucleic acid tests like the COBAS AmpliScreen HIV-1 and HCV Tests, can reduce the "window period" of detection for HIV-1 from 22 days to between 13 and 15 days, and for HCV from 82 days to between 32 and 22 days4. This shortening of the "window period" (the window of opportunity for a donation to escape detection) enables laboratories to further ensure the safety of the tissues used in a variety of therapies.
"We congratulate Roche Diagnostics and welcome its COBAS AmpliScreen HIV-1 and HCV tests for organ and tissue donors," said P. Robert Rigney, Jr., CEO, American Association of Tissue Banks. "We are pleased that our tissue banks will have another screening test available that is specifically licensed for cadaveric specimens. These tests will help to ensure the safety of tissue allografts."
Roche's PCR-based tests are used to screen more units of blood worldwide than any other nucleic acid tests. Roche's COBAS AmpliScreen Tests for the detection of HIV-1 and Hepatitis C have been approved for use in the US and abroad for screening whole blood, source plasma, and potential heart beating organ donors. The COBAS AmpliScreen HBV Test is approved for use in the EU and is currently the first HBV nucleic acid test to have been accepted for FDA review in the United States. COBAS AmpliScreen Tests are also used in other countries. Roche's AmpliNAT multiplex Test -- the first single-tube assay to test for HIV-1, Hepatitis C, and Hepatitis B in a single triplex reaction -- has been used exclusively by the Japanese Red Cross since 1999 to screen 100% of Japan's blood supply. Roche's TaqScreen West Nile Virus Test, the first in North America to fully automate the extraction, amplification, and detection steps of PCR, is currently in clinical trials in the US and Canada. Roche is also actively engaged in developing next-generation instrument systems and assays to further integrate and automate the blood screening process.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
Roche's Diagnostics Division offers a uniquely broad product portfolio and supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. Roche Diagnostics' North American headquarters is located in Indianapolis, Ind. For further information, please visit our websites: http://www.roche-diagnostics.com/press_lounge/blood_screening.html , http://www.roche.us and http://www.roche-diagnostics.us .
All mentioned trademarks are trademarks of a member of the Roche Group.
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This article posted April 20, 2005.