Blood test for Alzheimer's disease likely within 12 to 18 months

Millipore and Proteome Sciences sign licensing agreement to detect the disease in pre-symptomatic stage

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BILLERICA, Mass.—In what Proteome Sciences' Dr. Ian Pike describes as the "perfect combination," the company he serves as chief business officer, Millipore Corp., and the Institute of Psychiatry at King's College, London, are working together to develop multiplex immunoassays to measure Proteome Sciences' proprietary Alzheimer's disease biomarkers. The ongoing collaboration has been formalized by an exclusive license agreement by the two companies to develop new products that will help to advance the study of the disease.

"We contribute the biomarkers," Pike says, "Millipore develops the Luminex bead-based assays and Dr. Simon Lovestone's group contributes the clinical expertise. The ability to quickly test for these biomarkers will enable researchers to develop new drugs and diagnostics to treat and monitor patients with Alzheimer's."

Proteome Sciences is a publicly held company that began life running in "virtual mode," according to Pike, sponsoring research in academia that focused on oncology, organ transplant rejection, stroke, diabetes and obesity. In 2001, the company started its own wet lab and formed a relationship with King's College. Their early work centered on cutting edge proteomics using tandem mass tag technology—a novel quantification strategy for comparative analysis of complex protein mixtures by MS/MS.

The way the pair hooked up with Millipore was "non-linear," notes Jonathan DiVincenzo, president of Millipore's bioscience division.

"We were working on a project with Pfizer to develop assays related to neurodegeneration when we were contacted by King's College to develop assays for proteins it had identified. We worked with them to put together panels to detect circulating proteins," DiVincenzo says.

Working in collaboration with Lovestone's group, Proteome Sciences has established a strong portfolio of patent-protected blood biomarkers of Alzheimer's disease. A number of these biomarkers have been independently identified and their relationship to Alzheimer's disease confirmed by researchers at GlaxoSmithKline.

Millipore's expertise is making multi-analyte panels that don't conflict (see sidebar).

"Before Luminex,"DiVincenzo notes, you had to proceed one protein at a time. With Luminex, you can use 100 different plastic beads to detect the presence and concentration of circulating proteins." Because the beads are conjugated with specific labels and antibodies, it's possible to monitor a different analyte on each bead, he adds.
"This collaboration will help us achieve our broader goal of advancing the study of neurobiology and neurodegenerative diseases," says DiVincenzo. "This is the start of a long-term relationship. A joint development committee will work to refine the catalog of assays that we have available. We've earmarked a good portion of our R&D budget to work on this project."

According to DiVincenzo, 12 months is the target for reaching the clinic with as many as 20 diagnostic panels.

"We're very optimistic that changes we are seeing in very early Alzheimer's will be detected in the pre-symptomatic stage," Pike says. Asked if screening is likely to be acceptable, he points out mammography, the test for prostate specific antigen (PSA), the PAP test and others as evidence that such screening is acceptable, and says that indeed, screening is "the mainstay of good preventive medicine. Our goal is to have the tools to assay at the pre-symptomatic stage—the earlier the better. Proteome Sciences is keen to see the management of individual health maximized."

Millipore will acquire the exclusive right to develop and sell Luminex bead-based panels for research related to the study of Alzheimer's disease and other cognitive function disorders. Proteome Sciences retains all rights to clinical applications of these biomarkers. Financial terms of the license agreement were not disclosed.

Alzheimer's disease is the fifth leading cause of death in persons over the age of 65 in the U.S. with 5.3 million Americans afflicted by the disease. A suspected new case is identified every 70 seconds. The disease results in an economic burden that is estimated at more than $142 billion for 2005 with $112 billion in direct medical costs.

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