Patent for 'Mad Cow' Blood Test

[reader (the Second)]

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February 24, 2005 08:07 AM US Eastern Timezone

SeraCare Files Patent Applications for 'Mad Cow' Disease Blood Test

OCEANSIDE, Calif.--(BUSINESS WIRE)--Feb. 24, 2005--SeraCare Life Sciences, Inc. (NASDAQ:SRLS), an innovative developer and provider of human and animal based diagnostic, therapeutic and research products for the life science industry, announced today 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), also known as "Mad Cow" disease in humans.

SeraCare believes that the test, which was co-developed by Dr. Mark Manak, Chief Scientific Officer of BBI Biotech, a division of SeraCare in
Gaithersburg, Maryland, and scientists from the University of Maryland
Institute for Human Virology, could represent a significant improvement in
testing animals or humans for "Mad Cow" Disease and nvCJD, which was previously identified through post-mortem analysis of brain/spinal cord tissue. SeraCare intends to commercialize the test, an effort that is expected to commence by calendar year-end.

The Immuno-PCR test will enable the detection of the "Mad Cow" 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 "Mad Cow" 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, thereby creating a sufficient level of the signal to be accurately measured.


Michael Crowley, Jr., SeraCare's CEO, commented, "Today's patent applications underscore the strength of SeraCare's scientific team as well
as our commitment to delivering a growing array of cutting edge products
and services to our life science customers. 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. 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."

[Mike]

Might be time to buy some stock. Wonder if the USDA is going to limit the testing with these also?

[Sandhusker]

They'll just claim again that unlicensed tests can not be used by US businesses - omitting the fact that they themselves control what gets licensed and what does not.

[t]

The Immuno-PCR test will enable the detection of the "Mad Cow" 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 "Mad Cow" 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, thereby creating a sufficient level of the signal to be accurately measured.
This Sure will WORK as the prion is a large size protien and protiens stick together.