BioWorld International Correspondent

LONDON - Proteome Sciences plc claimed it would be the first to commercialize a product based on proteomics when it announced a deal to use its protein biomarkers for stroke in point-of-care diagnostic equipment.

The agreement, with Biosite Inc., of San Diego, will see Proteome's biomarkers incorporated into Biosite's Triage rapid diagnostic equipment. Proteome said its blood biomarkers can be used to differentiate between stroke and heart attack, and between ischemic and hemorrhagic stroke, distinctions that are critical to giving correct, and timely, treatment. As yet, there is no rapid way of diagnosing stroke.

Proteome CEO Christopher Pearce told BioWorld International, "This is very significant for us commercially, but it is also an important validation of our approach to proteomics. As far as we are concerned, we are not aware of any commercialization of a proteomics product so far."

Biosite specializes in developing protein-based tests for point-of-care uses and said its rapid diagnostics tests are used in 50 percent of U.S. hospitals.

Pearce said, "They are great partners to be in with. Biosite is very simply the fastest growing diagnostics company globally, and a leader in point-of-care. They are really smart guys who will rapidly translate these licenses into a diagnostic test for stroke, a major area of unmet need."

Although the terms were not disclosed, Pearce said the deal involves significant milestones and royalties. "We expect it should lead to revenues [to Proteome] in 2003- 2004."

Proteome, based in Cobham, UK, began its search for protein markers for stroke in 1996, taking two years to put together the initial collection of cerebrospinal fluid from 190 patients. From that it identified differences between stroke and control, and then using its skills in proteomics, identified a similar difference in blood.

The deal with Biosite is only for point-of-care diagnostics, and Pearce said he believes there will also be significant applications in drug discovery and clinical care. In drug discovery, Proteome has a collaboration with ReNeuron Holdings plc, of Guildford, UK, a specialist in cell replacement therapy in the treatment of central nervous system diseases, to apply Proteome's proteomics tools to identify proteins expressed during brain repair following stroke, as possible therapeutics or drug targets. ReNeuron has restored function following stroke in animal models.

Pearce also said he believed Biosite could be a good partner to develop tests based on Proteome's proteomics technique for detecting abnormal prions in blood, enabling prion diseases to be diagnosed in live humans and animals, and blood donations to be screened.

At present, prion diseases, or transmissible spongiform encephalopathies - including Creutzfeldt-Jakob's disease and variant Creutzfeldt-Jakob's disease in humans, bovine spongiform encephalopathy (mad cow disease) in cattle and scrapie in sheep - can be conclusively diagnosed only post-mortem.

Proteome also has discovered biomarkers for organ transplant rejection.