Proteome Sciences last week said that French diagnostic company BioMérieux will test its plasma-based stroke biomarker panel in Europe with an eye toward eventually commercializing it.
"The timeline is up to [BioMérieux], but clearly they're going to move very fast" to test the biomarkers on a "sizable" patient population in Europe, Proteome Sciences CEO Chistopher Pearce said this week.
According to Ian Pike, Proteome Sciences' business development director, researchers at his company began looking for stroke biomarkers in the mid-1990s. They started using 2D gels to compare the proteomes of cerebral spinal fluid from six patients who died of stroke and six patients who died of non-neurological disease.
Initially, they found about 14 gel spots that looked particularly interesting. From those spots, they identified 11 proteins, which were then validated immunologically.
The researchers also used SELDI technology to profile plasma from 20 stroke patients and 20 age- and sex-matched controls.
Proteome Sciences is "a pure research company. We have no ambition to get into diagnostics ourselves, or developing compounds, or whatever."
"We were quite uninterested in CSF as the final diagnostic body fluid because it's highly invasive and expensive to collect," said Pike. "So we looked for the overlap between CSF and plasma biomarkers, and that's been our general biomarker discovery strategy for most diseases we first look in the relevant tissue, then look in the most accessible body fluid, and then look for the overlap."
After analyzing a combination of stroke-related proteins identified from CSF and from plasma, Proteome Sciences researchers came up with a panel of about eight proteins that seemed most promising to serve as stroke biomarkers. They developed ELISA assays for these eight proteins, and performed the first validation studies of the biomarkers on 30 stroke patients and 30 age- and sex-matched controls.
Proteome Sciences calls its proteomic discovery platform ProteoSHOP, which stands for Proteome Sciences High Output Proteomics.
"We've been working in human disease aggressively since the mid-1990s," said Pearce. "We have a big portfolio of biomarkers. These stroke biomarkers are ongoing work from that process."
There is currently no high-throughput test for stroke available, said Pearce.
According to the World Health Organization, 15 million people worldwide experience a stroke every year. Of those, 5.5 million die while another 5 million are left permanently disabled.
"We have an enormous unmet medical need," he said.
Proteome Sciences and BioMérieux already have competition in the form of Nanogen and subsidiary SynX (see ProteoMonitor 4/20/2006). Nanogen has commercialized ELISA tests for stroke and traumatic brain injury that were developed based on biomarkers discovered by SynX. The company is currently clinically validating the ELISA tests and developing an optimized point-of-care test based on the validated biomarkers.
Rod Wilson, the president of Nanogen's Point-Of-Care Diagnostics division, and the former president and chief operating officer of SynX, estimated that his company's point-of-care test for stroke and traumatic brain injury could be on the market within 18 to 24 months.
It as not immediately clear whether BioMérieux plans to develop a POC stroke test.
Proteome Sciences' Pearce said his company is not interested in developing an actual diagnostic, point-of-care or otherwise; that's where partners such as BioMérieux come in.
"We're a pure research company. We have no ambition to get into diagnostics ourselves, or developing compounds, or whatever," said Pearce. "We've concluded some licensing agreements, and we will generate our revenue through partners who do the commercialization. Why reinvent the wheel? There are people who are better suited to develop and accelerate our work into the marketplace."
Pearce noted that the introduction of a stroke diagnostic into the market could happen a lot faster in Europe than in the United States because the US Food and Drug Administration's regulatory process generally takes longer than Europe's.
In addition to its stroke biomarker panel, Proteome Sciences has in various stages of development a number of biomarkers for Alzheimer's disease, cardiovascular disease, and an array of cancers.
Tien-Shun Lee ([email protected])