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Canon Eyes Molecular Dx Space as Shareholders OK Plan to Sell Arrays

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After years of flirting with the idea, Canon may soon enter the microarray market — and in turn become an in vitro diagnostics player.

Shareholders of the camera giant last week approved an amendment to the firm's articles of incorporation that will enable Canon to move forward with its plans to produce and commercialize its own line of DNA chips.

The participants of the annual shareholders' meeting in Tokyo added a platform to the company's charter that now allows the "production and sale of pharmaceutical products," under which microarrays are covered as a legitimate part of the firm's business.

"The approval by our shareholders of the amendment of the company's articles of incorporation is important," wrote Canon spokesperson Richard Berger in an e-mail to BioArray News, Pharmacogenomics Reporter's sister publication, following the shareholders' meeting. "It paves the way for us to commercialize a product in the future."

Most of the information that Canon was willing to disclose is years old, and the company preferred not to disclose how and when it will officially launch its product, or in fact what kind of product it would be.

"Unfortunately, I am only able to offer you a limited amount of information at this time," Berger told BioArray News last week.

Still, most evidence points to the notion that Canon will have in mind the clinical diagnostics market, as opposed to the Affymetrix-dominated and rival-rich research market, when it launches a product. The earliest scientific articles published about its technology show that the company has known for at least five years that its chips could be used to diagnose and treat cancer. Because of this thinking, Canon in 2000 had initially printed microarrays for the p53 gene, which codes for a protein that regulates the cell cycle and functions as a tumor suppressor.

Canon then participated in the DNA Diagnosis System for Clinical Use, a development project sponsored by Japan's New Energy and Industrial Technology Development Organization (NEDO). According to Canon, the company was working with NEDO towards developing a microarray for diagnosing colon cancer.

Berger would not comment on whether Canon was moving to commercialize a product based on the study, and only stated that the NEDO study was finished at the end of March 2004.

The move represents a new step forward for the company, which for the past five years has been racking up array-related IP in the US and toying with the idea of entering the market with budget microarrays produced with its Bubble Jet printing technology.

Similar news of Canon's impending entry to the market was heralded in 2003 [see BAN 5/9/2003] as well as in 2001 [see BAN 7/20/2001].

Despite these earlier public gestures, Canon again managed to generate buzz with the shareholders' decision to include biotech as a space for Canon products in the future. However, Canon is remaining mum about its new venture.

This could be because other large Japanese companies have hinted that they are interested in entering the field themselves. For example Toshiba recently told BioArray News that the European Union's recent approval of Roche's AmpliChip and Affymetrix's chip reader [see BAN 1/05/2004] will open a new market, and has "significant meaning to Toshiba and others" competing in the in vitro diagnostic field.

In addition, Kirin Brewery has been involved in discovering proteins and antibodies with a number of companies, including HySeq.

Due to its past involvement in developing in vitro diagnostics for NEDO, all arrows seem to be pointing in that direction for Canon's commercial launch. Another known fact is that Canon believes that by printing its chips using its Bubble Jet printing technology, for which it holds IP in the United States, it can shave costs off the traditionally expensive product and potentially grab a chunk of the fiercely competitive Japanese chip market.

"The [idea] that they will be using the chips in clinical diagnostics is bold and one that will be interesting to watch," said Shawn Levy, director of the Microarray Shared Resource at Vanderbilt University in Nashville.

Chris Barker, director of the Genomics Core Lab at the J. David Gladstone Institutes in San Francisco, agreed, and said that clinical diagnostics presents a less challenging front to Canon than selling chips to the research community.

"There is a very real opportunity here, if they haven't waited too long to jump into the field, and they may have," said Barker. "It depends on exactly how they attempt to implement it. The devil is in the details regarding whether this will be a good or bad move for Canon."

Even though prospective Canon customers appear unconvinced of the firm's chances in the marketplace, many still welcome the competition and look forward to the days when the company will follow through on its pledge to produce affordable arrays.

"I think it's potentially a good thing," said Kyle Serikawa, the manager of the Center for Expression Arrays at the University of Washington in Seattle.

"Inkjet technology still seems the like cheapest and most flexible way to produce a lot of tailored arrays quickly. Now that the FDA has approved microarrays for diagnostic work, the need for cheap microarrays is going to grow." (see BAN 1/05/05)

"I actually think it's great news," said Francis Barany, a professor of microbiology at the Sanford Weill College of Medicine of Cornell University, and a consultant with Applied Biosystems.

"Competition is always a good thing for a field," he said. "It's going to make everybody work harder to produce higher-quality products as they compete for the marketplace. At the end of the day the basic researcher and the clinicians win."

Barany said that while Motorola serves as an example of a big company that failed to develop a successful microarray product, GE has been more successful with the CodeLink platform, and could equally be seen as an example for Canon.

"The advantage of large companies is that they can afford to burn hundreds of millions of dollars until they get it right. And if this is going to become the multi-billion dollar market that all indicators say that it's going to become, then it's not surprising that the big guys want a piece of the action," Barany said.

— JP

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