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TOKYO, April 3, 2003 — Hitachi Ltd.’s Central Research Laboratory (CRL) says it has developed a DNA analyzer that can make gene diagnoses using only a 1-milliliter blood sample — plus it can do it for only 10 bucks, and in minutes instead of the three to seven hours it takes with current DNA chips.
The technology, based on a 150-micron-diameter fused silica capillary packed with 100-micron glass beads, can be ready for the market in 2005, said Yoshinobu Kohara, researcher at Hitachi CRL’s biosystems research department. The trick, said Kohara, is that the system eschews the traditional passive technology in DNA chips, and instead uses a pump to flush samples through and speed things up. Meanwhile, he said, the relatively cheap materials promise to cut costs.
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Jammed in the capillary, the nanobeads are coated with artificial DNA molecules designed to have a complementary base sequence to the genes. As the sample passes through the tube, target genes adhere to the complementary strands of DNA on the beads, and are detected by laser.
DNA chips in Japan cost $500-$2,500 apiece and testing can drag on for up to seven hours, Kohara said. Hitachi believes that given the simplicity of most of the equipment, the company can get per-sample tests done for about $10-$12 within a few years.
“With a DNA chip, you just hang around waiting for the targets to come through,” Kohara said. “We flush them through. The target molecules go very quickly to the surface of the beads, in one to 10 minutes, but the sensitivity is also very high.”
The approach is one of the most promising fruits of a restructuring Hitachi recently went through. The company is one of Japan’s “Big Five” electronics products and semiconductor companies, but now it wants to become a major biotechnology player.
Hitachi generally gets its basic research done at CRL, based just west of Tokyo, then passes on the product development work to its group companies. Takashi Irie, department manager at CRL’s biosystems research department, said Hitachi Software Engineering Co. is in charge of getting a first-generation system out by March 2005. The first market will be national research laboratories. Local doctors won’t see this technology until the end of the decade, Irie said.
Nao Koutani, assistant manager at Fuji-Keizai Co., a market research company, said that while the Japanese market is wide open for competition in the second half of the decade, Hitachi group companies could take a significant market share of Japan’s emerging bionano market. But he added that while the technology is feasible, he has a hard time believing Hitachi’s cost claims.
“Compared to the costs of today’s DNA chip market, this price looks too cheap. But even for the future market, it looks like a daring claim, I think,” he said.
Hitachi is facing some tough competition. Last November, Osaka University’s Institute of Scientific and Industrial Research announced it had developed a DNA chip that could sense the presence of target genes in around three minutes. Olympus Optical Co. announced in January that it plans to start mass-producing chips for about $424 each using technology developed with Dutch bioventure PamGene B.V. Toshiba Corp. has also announced a lab-on-a-chip that conducts 100 separate chemical reactions simultaneously using a fluorescein substrate that can amplify the DNA in the samples in about five minutes.
Another key competitor, said Koutani, is Takara Bio Inc., which last July formed an alliance with Nanosphere Inc. to market Nanosphere’s nanoparticle-based DNA probe technology. Takara is already selling nine versions of its IntelliGene DNA chip, according to Yoshihiro Hayashi of Takara’s Business Development Group.
Still, the journey from test tube to commercialization could be a costly path, said Neil Gordon, a nanotechnology consultant at Sygertech Consulting Group Inc. “The only sure thing about time estimates is that they are always wrong,” he said.
While he believes Hitachi’s technical claims, Gordon said he thinks the system probably has hidden problems not yet discovered.
“Known probes are currently placed as tiny dots on glass slides, nylon substrates or silicon. The use of nanoscale beads would be ideal and is theoretically possible. However, nanobeads may encounter numerous technical challenges associated with production and stability. I suspect that some ultrasensitive labeling and detection technologies will be used … However, ultrasensitive labeling does not fit in with the process and cost parameters described,” he said.
To date, CRL has made a trial of a 16-capilliary machine, but the company won’t comment on its performance..
“What don`t you get for $12?” asks Gordon. “There would have to be massive volume production to even consider costs in the $12 range,” he said.