Gradipore announces tech success

Sydney-based biotechnology company Gradipore (ASX: GDP) announced today that it had demonstrated removal of both infectious and non-infectious prion proteins from human biological samples using its proprietary Gradiflow technology.

Independent laboratory studies performed by the Scottish National Blood Transfusion Service (SNBTS) and Scottish company Q-One Biotech, in collaboration with Gradipore, pave the way for potential diagnostic techniques to detect prion infections in animals and humans, as well as increasing the safety of donor blood and blood products.

Prions are small pathogenic proteins that are thought to be the cause of a number of neurodegenerative disorders including variant Creuzfeldt-Jacob disease (vCJD) in humans, Bovine Spongiform Encephalopathy (BSE) in cattle and scrapie in sheep.

Tim Wawn, Gradipore's chief operating officer, said the company had identified that its Gradiflow membrane based separation technology could be used for both the separation and concentration of prion proteins more than a year ago. In November 2001 the company began a collaboration with SNTBS to further investigate the applications.

The results of the collaboration, which are to be presented at a major conference later this year, have shown that prion proteins spiked into human plasma were removed to below detectable limits, and could be selectively separated from other proteins in plasma and concentrated. According to Wawn, the technology also allowed separation of infectious and non-infectious prion proteins.

The ability to separate and concentrate prion proteins was crucial for development of a diagnostic assay, he said, as there was very little prion protein present in blood or other biological samples, and existing technologies were not able to detect prion disease short of examining brain tissue from slaughtered animals and autopsies.

While the Gradiflow technology was not a diagnostic assay in itself, Wawn said that it provided the enabling step for an assay to be developed. The company is now in discussions with potential partners for further development of diagnostic assays for prions in animals and humans.

In addition, the company was evaluating how to move forward with the use of the Gradiflow platform to remove prions and other pathogens from blood and plasma products.

"Clearly it's an important area for us and something that we're working on for expediency," said Wawn.

He said that the company was keen to continue its relationship with SNTBS, and both parties were evaluating the next research steps required.

The potential market for diagnosis and removal of prion infections is large, with a diagnostic test for cattle and sheep in Europe alone estimated to be worth $US2.5 billion.

Gradipore has already received patent protection for the discovery, with a US patent granted in December last year covering Gradiflow's ability to remove biological contaminants including viruses and prions.

The market responded positively to the announcement, with the share price rising almost 25 per cent to $AUD1.44 at the time of writing.