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Seeing Hole in Market, Daiichi, Toshiba to Develop Array-Based HPV IVD for Japan

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Daiichi Pure Chemicals, Toshiba, and Toshiba Hokuto Electronics have for the past two years been developing a microarray-based in vitro diagnostic system for human papillomavirus detection, the companies disclosed last week.

Toshiba and DPC, a subsidiary of Japanese pharma giant Daiichi-Sankyo Pharmaceuticals, claim the system is the first array-based IVD in Japan, and both said independently this week that they only have plans to serve the Japanese testing market at this time. They also signaled that they are seeking a partner that will help them clear regulatory hurdles in Japan.

The companies have collaborated on the system since January 2004. Toshiba Hokuto Electronics, a Toshiba company, has helped develop the technology and produce a prototype, and will be responsible for manufacturing the commercialized chip and detection system, the partners said. For its part, Daiichi will market and sell the HPV test, Osamu Sato, a group leader in Daiichi Pure Chemicals' R&D Division, told BioArray News this week.

The unnamed system could gain traction in several test markets in Japan "such as at major hospitals, universities, and commercial laboratories," Sato said. Cervical cancer can be treated and cured if caught early, and the presence of HPV is one of the earliest signs of being at risk for the disease.

He also said that Daiichi is seeking an outside partner that will help the firm commercialize the test. "A DNA chip for medical use requires high-level know-how in terms of certification approval procedures, medical sales channels ... for the marketing of Western countries. Therefore we thought it was necessary to cooperate with a certain company," Sato said. Daiichi has yet to announce a partner.

While Daiichi will lead the commercialization process, Toshiba and Toshiba Hokuto Electronics will act mainly as a manufacturer of the system, which is known internally at Toshiba as the Automated DNA Detection System, according to company spokesman Yuko Sugahara.

Sugahara told BioArray News this week that Toshiba sees a market for the system in "regular check-ups during pregnancy, check-ups for women to detect cervical cancer, and regular clinical examinations."

"Practically, we think that it will first be used when patients need precise examination after their check-ups for cervical cancer," Sugahara said.

According to Sugahara, Daiichi and Toshiba's chip is capable of detecting the 13 strains of HPV that are known to cause cervical cancer, and the hope is that "detection of strains will contribute to the progress of treatment and cures for cervical cancer." The Toshiba-built system uses in vitro electrochemical detection to relay results from an experiment, rather than fluorescence, Sugahara added.



Toshiba sees a market for the system in "regular check-ups during pregnancy, check-ups for women to detect cervical cancer, and regular clinical examinations."

In a statement discussing the HPV test last week, the companies acknowledged that they will use the microarray system in the future to target other applications, including infectious diseases. Sugahara declined to comment on what specific applications are next in the pipeline.

Outside Japan

While Daiichi and Toshiba look to capitalize on the market for HPV testing in Japan, array-based HPV IVDs are already in other markets. According to Jörg Stappert, head of Greiner Bio-One's biochip group in Germany, the company launched its PapilloCheck test for HPV in April. Stappert said that PapilloCheck, which was originally slated to roll out last fall, is "already being used in several labs in Europe."

Greiner claims that its PapilloCheck HPV-Screening DNA-Chip can identify 24 types of HPV and can classify possible cervical cancer patients into high risk and low risk groups. PapilloCheck is certified for clinical use in Europe, according to Greiner.

In addition, Norchip, a Norwegian diagnostics company, offers a plate-based test called PreTect HPV-Proofer that can detect six strains of HPV for identifying women at risk for developing cervical cancer.

Other European companies with HPV tests in development or on the market include Digene, Innogenetics, and Roche. However, none of these tests use microarray technology.

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