This story has been updated from a version posted Nov. 11 to include additional comments from CapitalBio.
Roche NimbleGen will work with Beijing-based CapitalBio to develop instruments and products to enhance and automate its microarray workflow for use in preventive and personalized diagnostics, the firms said last week.
The collaboration is part of a larger strategic partnership that will focus on "furthering microarray technologies and complementary products for molecular diagnostic applications," the companies said. Roche and CapitalBio will also establish educational facilities across China to support the adoption of tests based on Roche's NimbleGen arrays and 454 next-generation sequencing platform, as part of the deal.
Financial details of the new partnership with Roche were not discussed.
Roche has previously discussed its desire to see its arrays used clinically. In an interview with BioArray News in July, Roche NimbleGen CEO Frank Pitzer said the firm is preparing to submit an array-based test for genetic abnormalities to the US Food and Drug Administration for 510(k) clearance. He said at the time that the firm is considering developing tests for other indications, such as in oncology (BAN 7/20/2010).
CapitalBio sells biochips, microarray-related instruments, and microarray services. The decade-old firm became a certified Roche NimbleGen service provider earlier this year (BAN 2/16/2010). CapitalBio recently established an independent medical testing laboratory in Chengdu, China, and expanded its microarray genomics service facility at its Beijing headquarters, the firms noted.
Keith Mitchelson, vice president of corporate business development and marketing at CapitalBio, told BioArray News in an e-mail this week that the company could be an asset to Roche as it advances tests based on its array and sequencing platforms.
Mitchelson said that CapitalBio maintains "positive relationships with numerous major hospitals and health organizations in China" that have allowed it to introduce "advanced molecular diagnostic tools."
He noted the firm itself has developed microarray-based tests that have gone on to win clearance for diagnostic use from the China State Food and Drug Administration.
For instance, CapitalBio's Deafness Gene Mutation Detection Array Kit, which enables high-throughput screening of known mutations related to hereditary hearing loss, was cleared by the CSFDA last year.
CapitalBio's ability to "develop, certify, and introduce advanced microarray-based molecular platforms and tests for the China medical market is one area of cooperation" between the Chinese array firm and Roche, Mitchelson said, adding that the "success of these products in China will provide an opportunity to bring them" to other markets.
CapitalBio believes "that there will be other opportunities to harness the capabilities of both companies for product research and development, manufacturing, marketing and distribution in China and international markets," Mitchelson added.
Chengdu and Chongqing
According to Mitchelson, CapitalBio's new Chengdu facility, located in the province of Sichuan in western China, already offers a range of microarray-based diagnostic assays to more than 100 hospitals. He said that the firm now plans to introduce assays for "molecular cytogenetics and post-natal testing based on the Roche NimbleGen platform" into its Chengdu facility.
CapitalBio also intends to introduce human leukocyte antigen testing using the 454 platform through the Chengdu facility. "Molecular services using [454 sequencing] for the personalized and preventative diagnosis and stratification of different cancers" will also be launched at the facility. "We think that there will also be very significant interest in next-generation 454 sequencing-based diagnostics, and we plan to bring this platform into our range of medical testing services," he said. Mitchelson did not provide a timeline for the debut of either service.
In terms of helping to automate Roche NimbleGen's microarray workflow, Mitchelson said the goal of the partnership is to "further enhance the array workflow with instruments that will allow for greater throughput and easier implementation." For example, he said that NimbleGen customers running larger projects could require more automation for washing and drying the slides. Mitchelson suggested that CapitalBio's existing Slidewasher system "may be useful for meeting this customer need."
On the education front, Mitchelson said that CapitalBio and Roche will provide workshops for laboratory managers at the 2011 Chinese Conference on Molecular Diagnostics, which will be held in April at the International Convention Center in Chongqing. CapitalBio has also established "branch centers at leading institutions across China for partnership in developing molecular testing techniques and novel molecular applications," he said. "We plan to contribute in the future to educational facilities for molecular R&D and the application of clinical molecular diagnostics."
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Manfred Baier, head of Roche Applied Science, in a statement called his company's new partnership with CapitalBio a "significant step for Roche in forming closer relations with China's premier biochip development company." He added that the agreement "formalizes a closer relationship with CapitalBio" since it became a Roche service provider.
Affymetrix Cooperation Still 'Very Positive'
In addition to being a Roche NimbleGen certified service provider, CapitalBio is also a certified service provider for Affymetrix and Sequenom. In addition, the company entered into a strategic partnership with Affy in 2005 that provided it with a license to sell the company's products in China (BAN 4/27/2005).
In light of the new deal with Roche, Mitchelson said that CapitalBio continues to cooperate with Affy, and called the firms' relationship "very positive." He said that CapitalBio and Affy co-operated in the research, development, and production of the fluidic station and scanner station components of the Santa Clara, Calif.-based array maker's GeneAtlas System, which was launched earlier this year. CapitalBio is also the exclusive manufacturer of the GeneAtlas instruments in China, he said.
Additionally, Mitchelson said that CapitalBio will soon begin offering gene expression services on the GeneAtlas and will cooperate in the launch of genotyping and expression services on the higher-throughput GeneTitan instrument.
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