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With New OGT License in Hand, CodeLink Aligns for Clinical Future -- or ImageGenomics?

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In the weeks since General Electric announced the proposed $9 billion acquisition of Amersham, questions have arisen on the role that Amersham’s CodeLink line of microarrays might play in the future combined business.

Amersham may have signaled its plans for the microarray product in a statement released during the Chips to Hits conference in Boston last month, in which it announced the expansion of its previous licensing agreement with Oxford Gene Technology, the UK-based firm that manages the intellectual property created by microarray pioneer Sir Edwin Southern.

The two companies initially entered a licensing agreement in December 2002, with Amersham obtaining license to OGT’s patents for research applications. With this deal, the financial details of which were not disclosed, Amersham expands its rights to include clinical diagnostic applications, and the right to provide its customers with sublicenses to the patents.

“I think the message getting across here is one of commitment,” Trevor Hawkins, Amersham Biosciences vice president of development, discovery systems, told BioArray News. “The addition of the OGT licenses is a demonstration of our commitment to provide our customers the licenses they need to be successful with the product.”

With the expanded rights, Hawkins said the company will move ahead in discussions with pharmaceutical partners to “see how CodeLink can be used in a clinical diagnostic setting.”

Oxford Gene Technology deferred any comment on the deal to Amersham.

The diagnostic licensing deal occurs against a backdrop in which the pending merger is slated to link Amersham’s unique imaging chemistries and GE’s imaging platforms.

Hawkins sees CodeLink playing a part in this joining of technologies.

“The concept of mixing together in vivo diagnostic information from MRI or PET with the in vitro information from CodeLink is really one of the core strengths of Amersham,” said Hawkins. “I believe as we go forward with the concept of personalized medicine, you will see a merger of the in vivo and in vitro world and the merging of MRI and information from microarrays would be a good example. It’s conceptual, but an area that is getting a lot of interest.”

Amersham has owned CodeLink since June 2002, when it purchased the technology from Motorola for $20 million.

The CodeLink product line is regarded as the No. 3 player in the preprinted, industrial-scale microarray market, behind market leader Affymetrix, then Agilent Technologies. Much of the first year of Amersham’s ownership of the product line was spent in integrating the product line into the company, constructing a new fabrication facility in Chandler, Ariz., and introducing four new microarray products — including the Sept. 10 rollout of the CodeLink Human P450 SNP Bioarray, which joins the Affymetrix-manufactured Roche Diagnostics AmpliChip microarray (see BAN, 4/25/2003) in having clear designs on the vision of personalized medicine.

The CodeLink Human P450 SNP Bioarray, which genotypes 110 SNPs within nine P450 genes (CYP1A1, 1A2, 1B1, 2C9, 2C19, 2D6, 2E, 3A4, and 3A5), is “designed for screening clinical trial populations to determine their toxicogenetic profiles and for the discovery of novel associations between P450 genotypes and phenotypes,” the company said in the statement issued in announcing the product.

Still, as a business, CodeLink is costing more than it brings in. Amersham Biosciences’ discovery systems segment reported an operating loss of £10 million for the first half of the year, including continued investment in the CodeLink, which had net expenditure of £7 million in the first half.

However, the company reported “steadily increasing sales” for the CodeLink line in its third quarter financial report on Oct. 29.

The FDA

The recent decision by the US Food and Drug Administration not to accept Roche Diagnostic’s AmpliChip microarray as an analyte-specific reagent —along with a draft document that specifies ways in which biopharmas may submit pharmacogenomics data voluntarily and promises that the agency will not use the data as a critical deciding factor in the drug-approval process — has somewhat defined the regulatory parameters that will determine how microarrays expand from the research market to the clinical market.

“The technology is moving forward, with new applications and new tools being developed every day,” said Hawkins. “It is a moving target, but [FDA actions] show that there is an intense interest in the use of microarrays in clinical diagnostics, and that underlines the fact that this is going to be a major market.”

Hawkins, who managed the US Department of Energy’s Joint Genome Institute and was involved in leading its efforts in the race to sequence the human genome before joining Amersham in February 2002, said the growth of the microarray industry is different and distinct in comparison to the excitement of the human genome project.

“With the FDA involvement and the clinical and patient outcomes that may come from the use and interpretation of this data, it’s very different,” he said. “What a wonderful time we live in to be able to push the technology forward in this way.”

Automating CodeLink

The one thing missing from the CodeLink product line, after the addition of the extension of the OGT license and the ability to sublicense for clinical and diagnostic applications, is a method and a technology for automating CodeLink processing in a high-throughput fashion.

“It is lacking today, but it is not lacking in our development portfolio,” said Hawkins.

“We recognized that when we took on the business. We are working with a number of key players in the automation field to develop methodologies and approaches that will be announced in the next year,” Hawkins said.

—MOK