ability to remove prions from blood

May be the reason this stock has been moving up recently. If the bio sector regains favour it might take off - one for the watch list?

Gradiflow proves ability to remove Infectious Prions from Human Blood
06 Feb 2003
Australian biotechnology company Gradipore today announced that its GradiflowTM separations platform has successfully isolated and removed infectious and non-infectious prion proteins (PrP) from human biological samples in independent laboratory studies.

Prion proteins are the smallest known pathogens and are believed responsible for a group of neurodegenerative diseases, which include variant Creutzfeld-Jacob disease (vCJD) in humans, Bovine Spongiform Encephalopathy (BSE or “mad cow disease”) in cattle, and scrapie in sheep.

The isolation and removal of prion proteins has highly positive implications for the healthcare, biotechnology and blood supply markets. These include -

- The development of diagnostic tests for infectious prion contamination in animals and humans – which can be carried out on a live subject and which are also much more accurate
- A significant increase in the safety of human donor blood and blood products
- An increase in bio-safety across a broad range of research and manufacturing processes.

“We are very encouraged by the results of these experiments. The outcome of this collaborating project could allow early prion diagnosis, limit the potential of further transmission and possibly assist in treatment of these diseases,” said Robert Lieb, Global CEO for Gradipore. “Indeed, what they show is that Gradiflow may fill the unmet need for a non-invasive prion diagnostic tool for animals and humans, and can provide pure isolates of various proteins useful for research, development, and therapeutic purposes.”

Technology currently exists to detect the presence of infectious prions only after the cattle etc have been slaughtered. This process is also time consuming and can allow the disease to spread. The development of a diagnostic test for livestock that can detect infectious prions in live subjects, could expedite discovery of possible disease. At an average cost of $15 per test , it represents a market opportunity of up to approximately US $2.5 billion for cattle and sheep in the European Union only . The global opportunity, combined with the possibility of a human diagnostic, is expected to be much larger.

The new experiments were designed, performed and validated in Scotland by the Scottish National Blood Transfusion Service (SNBTS), a leading international authority in the field of prion diagnostics, in collaboration with Q-One Biotech, an authority in the design and implementation of virus, prions and other contaminant validation studies. The outcomes showed -

- Prion contaminants deliberately introduced into human plasma could be removed below detectable limits using the Gradiflow process
- The contaminants were effectively separated from IgG and albumin proteins
- The ability of the Gradiflow technology to selectively separate and concentrate prions. This cannot be achieved by current technology.

"As far as I am aware, the Gradiflow platform is the only technology which can achieve these using one technology platform, and it has the ability to achieve these outcomes concurrently," said Dr Hari Nair, Gradipore's US Chief Operating Officer.

"Gradiflow has now proved its ability to separate and remove bacteria, viruses, endotoxins and prions from biological samples, and that has huge implications, for example, for blood banks around the world."

An abstract has been submitted to present the full results at a scientific forum later in 2003.

SNBTS Lead Scientist Dr. Ian MacGregor stated, “we have been impressed with this technology and these studies also show that the technology may have huge implications in the multimillion dollar prion diagnostic industry”.

All studies were carried out in highly controlled laboratory conditions.

“All prion-related testing utilising the Gradiflow separations technology was performed to the high standards that our organization maintains in accordance with international standards for quality control,” said Q-One Biotech director, Malcolm Brattle. “We found that Gradiflow technology is a promising tool for the separation of disease-associated prions from human biologics.”

Gradipore has a standing agreement with the SNBTS covering the study of the Gradiflow technology for infectious prion removal, the development of a prion diagnostic kit for early stage detection of prion disease, and further research to assist in the treatment of vCJD.