BioWorld International Correspondent

LONDON Proteome Sciences plc said it has been granted a patent on its proteomics technique for detecting abnormal prions in blood, paving the way to the first diagnostics for prion diseases in live humans and animals, and offering the possibility of wide-scale screening of blood donations.

At present prion diseases, or transmissible spongiform encephalopathies (TSEs) including Creutzfeldt-Jakob’s disease (CJD) and variant Creutzfeldt-Jakob’s (vCJD) disease in humans, bovine spongiform encephalopathy (BSE) in cows and scrapie in sheep, can only conclusively be diagnosed post-mortem.

CEO Christopher Pearce told BioWorld International, “In the short term the serious commercial value is more likely to be in BSE and scrapie, where the market for testing is more developed. However, a while ago we wouldn’t have considered there would be a requirement to test blood for transfusions; now everybody we talk to is convinced it will be a requirement.”

In controlled studies using human blood from CJD/vCJD patients compared to control samples, Proteome identified changes in protein expression from which it developed assays that it said have high sensitivity, specificity and predictive accuracy. The same assays are able to detect BSE in cattle, and studies to assess if they can detect scrapie in sheep are in preparation.

The company is talking to potential commercialization partners. “We are a pure research company,” Pearce said. “Our skill is in high-throughput proteomics, and we will seek partners to bring this to market. Obviously, with the granting of the first patent, we are in a stronger position.”

To date 104 people in the UK are known to have died from vCJD, which is thought to be caused by eating beef from cattle suffering from BSE, or mad cow disease. The UK newspaper The Guardian reported last week that eight of these people were blood donors, and that 22 people received blood donations from them. The incubation period is not known and experts are divided on how many more people may be incubating the disease. “We think blood centers will want to use a test that allows them to screen donations,” Pearce said.

He also said this advance demonstrates that proteomics will be one of the keys to unlocking the value in the Human Genome Project. “When [the sequencing of] the genome was completed there was an expectation of commercial products. But now you begin to see the value is coming from the proteome.”

Apart from detecting TSEs, Proteome Sciences, based in Cobham, Surrey, said its proteomics technology can pick up protein markers that are useful for the diagnosis of other diseases including stroke and organ transplant rejection. “We can apply the technology across a wide range of complex disease areas where there are few diagnostics. For example, currently there is no good test for stroke. We can differentiate between stroke and heart attack, and between ischemic and hemorrhagic stroke,” Pearce said.

The ability to uncover differential protein expression in such diseases also would generate many potential drug targets.