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Applied Microarrays Says Year-to-Date Sales Swell 85 Percent on Protein-Array Demand

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By Justin Petrone

Applied Microarrays' revenue for the first nine months of 2010 has grown 85 percent over 2009, largely driven by contract protein-array manufacturing partnerships, according to the firm's CEO.

Over the same period, the Tempe, Ariz.-based firm, which was founded in 2007 when it acquired GE Healthcare's CodeLink bioarray platform, has seen sales of legacy CodeLink products dwindle to less than 5 percent of its total revenue.

By comparison, CodeLink sales represented about 10 percent of the company' revenue in 2009.

CEO Alastair Malcolm said that the bulk of AMI's sales are now derived from printing protein arrays and plates for customers involved in biomarker discovery. He declined to break out revenue numbers for the privately held firm.

"The biggest drivers for us are protein array partnerships both for microtiter plate formats and lab-on-chip formats," said Malcolm. "We run the range from very low-density diagnostic signatures on protein arrays all the way through to 20,000 proteins or peptides that are getting used for biosignature discovery."

BioArray News spoke with Malcolm during Select Biosciences' Advances in Microarray Technology conference in San Diego last week.

Malcolm, who was involved in the development of the CodeLink platform at Motorola over a decade ago, said that the array unit was always capable of printing proteins, but that revenues from protein array sales were "effectively zero" until the platform came into AMI's hands.

"We had been doing protein arrays under Motorola, and that continued at GE at the R&D level," Malcolm said. "The antibodies have now gotten to the level that you can produce consistent arrays from batch to batch. I also think that if you can make the array quantitative and then be able to track proteins over time, the medical community can determine if the therapies are actually working."

To build its profile as an array manufacturer, AMI recently received ISO 13485 certification, an International Organization for Standardization requirement that mandates manufacturers to maintain a quality-management system. The certification shows that AMI is able to manufacture products that meet regulatory requirements as medical devices, and that can be used in related services.

"We saw so many of our customers having ambitions to go into diagnostics that we decided to position the company with that certification," he said.

When AMI acquired most of GE's CodeLink assets, save the CodeLink activated microarray slides that were later snatched up by SurModics, the new firm inherited a whole-genome gene-expression array business that included products for human, mouse, and rat studies (BAN 5/8/2007). While not the leading chips on the market, CodeLink bioarrays were used, for example, as one of the microarray platforms in the US Food and Drug Administration-hosted Microarray Quality Control project (BAN 10/3/2006).

Malcolm said that sales of those expression arrays are now down to "less than five percent" of the company's 2010 sales and that the CodeLink catalog customer base consists of around 40 individual customers that are still using the platform occasionally.

"I think the gene-expression market is starting to plateau and we haven't pushed the platform in the marketplace or developed higher-density iterations of it," Malcolm said. "It was never a strategic part of Applied Microarrays' business model. It was a good product but we never intended to develop it."

Instead, the company saw the catalog arrays as a "source of revenue in the early days to fund [our] real strategy: to develop contract manufacturing partnerships based on the facility and the assays that we bought from GE."

Malcolm pointed out that the business has grown year over year. In fiscal 2010, revenue from contract manufacturing deals increased 50 percent over fiscal 2009 (BAN 12/8/2009). The company has already passed its 2009 sales, he said, and there are three more months in the year.

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Malcolm estimated that in 2011, custom microRNA array sales on the CodeLink platform will outperform catalog gene-expression sales. AMI introduced custom CodeLink microRNA arrays after it acquired the CodeLink assets from GE.

"We are focusing on lower-density arrays and there are less than 2,000 microRNAs of interest, so it is a good fit," said Malcolm. He noted that AMI continues to manufacture a microRNA array product called MirLink for Austin, Texas-based Asuragen.

To support the new applications, AMI has made a few investments. Last year, for instance, the company added personnel and expanded its manufacturing capabilities by about 30 percent. AMI also now bundles reagents with its arrays, and provides the final formulation and final packaging for its customers' products. The company has also modified its printing capabilities to handle protein arrays.

"The base platform is still the Motorola platform," said Malcolm. "It was primarily running oligo arrays and we made a lot of adaptations to accommodate protein arrays."

For example, the firm has adapted the technology to support larger droplet volumes, and, looking forward, Malcolm said the company will continue to adapt its approaches to suit the protein-array market but will not radically change its approach.

"We don't need new tools for the business," he said. "We will adapt our tools to the protein array and diagnostic markets," areas where he said AMI continues to see "substantial growth."

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