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Toshiba Steps into Diagnostic Array Market With Semiconductor-Based Hepatitis C Chip

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  Japanese semiconductor chip manufacturer Toshiba made its official debut in the microarray market with the October 18 announcement that it has developed an electrochemical chip for use in the treatment of the liver disease hepatitis C.

The biochip, which Toshiba developed in collaboration with Japanese venture GeneCare Research Institute, is not only Toshiba’s first foray into the biomedical market, but is the world’s first screening chip for hepatitis, said Toshiba spokeswoman Midori Suzuki.

The single-use chip is based on the company’s standard semiconductor technology, consisting of a printed circuit board on a silicon base. The probes are single nucleotide polymorphisms (SNPs) identified by research conducted at Toshiba Hospital as related to treatment response for the common hepatitis C treatment interferon.

Toshiba is currently aiming to mass produce the chip and commercialize it by the end of March 2003, but will only market it in Japan. This is because the SNPs on the chips are those common among the genetically homogeneous Japanese population. The hepatitis C virus, Suzuki said, is particularly common in Japan, where it is estimated to infect two million people.

Suzuki noted that expansion to the worldwide market will require serious examination of such scientific issues as how to modify the chip to locate the appropriate SNPs in different racial populations.

In its initial marketing efforts, Toshiba is likely to target hospitals, clinics, and screening centers. Price will depend on the volume it is able to produce. “We assume it will initially start as quite expensive, at tens of thousand yen (hundreds of dollars), but will become a lot cheaper once the demand increases,” said Suzuki.

After the chip is successfully commercialized, the company plans to establish a standardized platform for DNA-based diagnostic systems, Suzuki said. This could pit Toshiba against the current global players in the DNA diagnostic chip market, Motorola and Nanogen (see p. 3).

Nanogen has a full-scale agreement in place with Hitachi Instruments of Tokyo, in which Hitachi manufactures Nanogen’s NanoChip workstations and has the exclusive right to distribute to distribute these workstations in Japan. Nanogen has 13 partnerships to develop disease-diagnostic applications for its workstation.

Toshiba, however, has as yet not revealed plans to develop biochips for other diseases.

Toshiba’s exploratory foray into biochips can be seen as an effort to join a growing trend in Japan. In the past year, major Japanese companies, from brewers to technology titans, have begun racing to reconfigure their business for the biochip market. These efforts have focused almost entirely on Japan, in large part because development efforts are hampered by the reach of patents filed by foreign-based companies such as Affymetrix.

Seventy-five-year-old beverage manufacturer Takara Shuzo, a pioneer in Japan’s private biotechnology sector since 1979 and license holder of Affymetrix’s patented spotting technology, currently holds the largest share of Japan’s DNA chip market, slightly less than 50 percent, by the company’s own estimates.

Developing next-generation chips has proved attractive to a significant number of start-ups among Japan’s infant biotechnology sector as well. Precision System Science, one of two Japanese biotech companies to launch an initial public offering, recently established a subsidiary, BioStrand, in the United States earlier this year to commercialize its 3D chip, which it claims will work in a fully automated system and is expected on the market by the end of next year.

Another startup, TUM Gene, has developed an electrochemical chip, which it claims can do traditional sequencing analysis as well as SNP detection.

But Toshiba possesses a distinct advantage over these startups and even established companies. Not only does it have a well-oiled global distribution network for other products, from semiconductors to computers, it also possesses global patents for its current-carrying DNA chips. But it is too early to tell whether the company can effectively leverage its global technology reach in the specialized market for diagnostic biochips.

— Sara Harris, Tokyo

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