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Protein Arrays Hindered By Lack of Content, Patent Issues, Antibody Costs and Logistics

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BOSTON — Though the protein arrays market is growing by about 28 percent per year, it is hindered by a lack of content, difficulties in setting up business partnerships with antibody companies, and legal problems involving patents, analysts specializing in protein arrays said here this week at IBC’s protein arrays conference.

“The availability of high-quality capture agents is limited,” said Steven Bodovitz, the principal of BioPerspectives, a San Francisco-based biotech consulting company. “That results in a content problem, in terms of capture and interaction protein chips.”

Protein chip companies must establish relationships with antibody-making companies in order to produce chips with content that customers seek, said Robert Negm, the corporate development manager in the life sciences department at Schleicher and Schuell BioScience, a diagnostics company based in Dassel, Germany.

Negm estimated that there are 46,169 different antibodies available from over 24 different vendors worldwide.

“Is there really a limitation of antibodies out there?” he questioned. He then suggested that rather than a lack of antibody types, there may be a lack of accessibility to antibodies suitable for acting as capture agents on chips due to company boundaries and costs.

Negm calculated that it costs approximately $200 for 100 micrograms of antibody, and that approximately .5 milligrams of each antibody are needed for manuafacturing a chip. In addition, the antibodies must be reformatted into a configuration that is suitable for arraying. Given these costs involved in developing a protein array chip, Negm said that protein chip companies should share the risks of development with antibody companies.

“The companies should collaborate in a milestone-driven project,” Negm suggested. “They could start with 100 antibodies, then if that is successful, move to a larger scale project such as a 1,000-antibody project. If either partner finds that it is not working out, they can walk away.”

Jorge Goldstein, a biotechnology lawyer at Sterne, Kessler, Goldstein and Fox, pointed out another problem with developing microarrays: patented sequences and diagnostic proteins.

“It’s a minefield of patent problems out there,” he said.

One example of a patent that has created problems in diagnostics is the patent on the BRCA2 breast cancer gene. Clinicians in hospitals are inhibited, and in some cases prevented, from using the BRCA2 diagnostic test because it is licensed exclusively to Myriad Genetics. A similar problem occurs with Apo-E, a gene that plays an important role in atherosclerosis and cholesterol regulation.

One solution to this problem created by exclusive patents is the patent pool — a conglomerate of patents that third parties such as clinical laboratories, hospitals, or chip manufacturers can access by paying royalties in a type of one-stop shopping.

However, patent pools can be difficult to set up because they can not violate anti-trust laws, and companies must be convinced to add their intellectual property to a pool that will result in diluted revenues, Goldstein pointed out.

“There are no established patent pools in the area of diagnostics yet. However, they have been successfully used in, for example, the area of electronics,” Goldstein said. “Unless they are crafted carefully, they can run into problems with anti-trust laws and with the licensing organizations disagreeing on third-party violations.”

Despite problems with antibody licensing and costs associated with putting them on an array, both Bodovitz and Negm predicted that the protein arrays market will show steady growth over the next four years.

Bodovitz predicted that the protein arrays market will increase from approximately $220 million this year to about $580 million in 2008. Within this market, he pointed out that the beads market, currently led by Luminex, is growing at about twice the rate of the planar arrays market, which is led by Biacore and Ciphergen

“Though there are currently a smaller number of bead companies, they are an important market to consider,” said Bodovitz. “The beads provide good assays. They are flexible, reliable, and, most importantly, widely available. It will be interesting to see how the beads play out in the next few years.”

— TSL

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