SeraCare to patent prion blood test in several countries

Cattle Market & Farm Reports, Editorials
Feb 28, 2005
by WLJ
Biotech company SeraCare Life Sciences, Inc. is attempting to patent a blood test for the prions that cause bovine spongiform encephalopathy (BSE) and its human variants.
A developer and provider of human and animal based diagnostic, therapeutic and research products SeraCare announced Feb. 24 that it has filed patent applications in the United States, the European Union, Japan and Australia for an Immuno-PCR test, a novel blood-based test for infectious prions, the proteins that cause Creutzfeldt-Jakob Disease (CJD) or new variant CJD (nvCJD), disease in humans.
SeraCare believes that the test, co-developed by Dr. Mark Manak, chief scientific officer of BBI Biotech, a division of SeraCare in Gaithersburg, MD, and scientists from the University of Maryland Institute for Human Virology, could represent a significant improvement in testing animals or humans for BSE and nvCJD, which was previously identified through post-mortem analysis of brain/spinal cord tissue. SeraCare intends to commercialize the test. That process should start by the end of this year.
The Immuno-PCR test will enable the detection of the BSE-related protein in blood, cerebrospinal fluid, or nerve tissue by combining two well accepted testing methods: antigen capture and Polymerase Chain Reaction (PCR), into a two-stage Immuno-PCR testing regimen. In the first stage, the BSE prion (essentially a deformed normal cellular protein) is isolated by binding with a highly specific antibody. The antibody/prion complex isolated in the first stage of the test is then used to amplify the detection signal in the second stage using the PCR process, creating a sufficient level of the signal to be measured.
Michael Crowley, Jr., SeraCare's CEO, said, "We believe this test could prove instrumental in helping to protect the health care and global life sciences industries from the possible use of contaminated instruments or materials in a variety of procedures and processes.
"In particular, we believe our customers will be able to use this test to certify that animal or human-based components of their diagnostic, therapeutic or cell culture products are prion-free. We believe such a designation would add value to their products while also serving to expand their potential addressable markets worldwide,” Crowley said. “Additionally, we believe the Immuno-PCR test could serve an important role in screening blood and organ donors worldwide for nvCJD, similar to PCR tests currently used for diagnosing hepatitis, HIV, and other viruses." — WLJ