Gradipore has entered into a development agreement with the Scottish National Blood Transfusion Service (SNBTS), for the early detection of abnormal vCJD prions in blood utilizing Gradipore's membrane-based separations technology platform, Gradiflow.

SNBTS is a leading international authority in transfusion medicine and research in the field of prion diagnostics, working to improve patient care. SNBTS is one of the very few groups in the world working with abnormal prions.

The planned outcomes in the first year are:

??Validation of the Gradiflow separation technology to remove abnormal and potentially infectious prions from biological materials, such as blood;

??Commence the development of a prion diagnostic kit for early stage detection of prion disease, with the potential of testing for abnormal prions from other tissues as in Mad Cow Disease;

??Further research results to assist in the treatment of variant Creutzfeldt-Jacob Disease (vCJD).

For Gradipore, this agreement will provide further scientific validation of the Gradiflow technology and a diagnostic kit for the detection of infectious prions. The commercial market of such a diagnostic kit for use in the livestock and human blood and tissues markets in Europe alone is in excess of US $100 million per annum.

For the Scottish National Blood Transfusion Service, this agreement provides access to the Gradiflow technology and potentially a new, more sensitive diagnostic test for infectious prions. Although the risk of transmission of prion diseases by human blood is hypothetical, it is envisaged that upon successful completion of the development program, SNBTS would use the Gradiflow-based prion diagnostic test as part of their blood screening processes.

Prions are the infectious agents that cause a family of fatal neurodegenerative diseases or Transmissible Spongiform Encephalopathies (TSE). The most notable TSE's are bovine spongiform encephalopathy (BSE) or "Mad Cow Disease" in cattle, and the variant of Creutzfeldt-Jacob Disease (vCJD) in humans. Infectious forms of prion disease are also known in animals, including scrapie in sheep and chronic wasting disease in mule deer and elk. Prion diseases are difficult to diagnose because they are not amenable to standard detection methods used for identifying bacteria and viruses.

"As previously reported the Gradiflow separation technology has already been demonstrated to successfully remove non-infectious prions from human plasma," said Dr. Hari Nair, CEO of Gradipore Inc. "This agreement with SNBTS will now allow us to extend our work to infectious prions." "Prion diseases in humans and livestock cannot be detected early and are nearly always fatal," added Dr. Nair. "The ability to detect the presence of prions in humans and livestock represents an enormous market opportunity because it would help to relieve concern about the safety of the blood supply and animal products. This research involves and requires internationally recognised prion scientists, such as those at SNBTS, able to use highly sensitive separations technology like Gradiflow. The aim is to develop diagnostic techniques to detect abnormal prions in blood."

Gradiflow has successfully separated and retained prion proteins from biological materials, thus allowing for the capture and removal of prions. As prions are usually present in very low concentrations in blood, blood components and other biological fluids, they are extremely difficult to detect. The Gradiflow can be used to concentrate the prions in the sample away from the plasma, white cells, whole blood and other biological fluids.

"One of the key qualities of the Gradiflow system is its ability to rapidly separate prion proteins based on size and charge in biological samples," said Dr. Ian Macgregor, lead scientist, Products and Components research group of SNBTS. "Our aim is to replicate that success in infectious prion applications, and develop the Gradiflow technology as the first step application for prion separation and concentration which we feel will lead to a rapid and extremely sensitive high-throughput assay system for screening prion infectivity in biological samples."