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CapitalBio, Ahead of Lab Expansion, Debuts Chromosomal Microarray Analysis Services in China

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The global adoption of microarrays for the detection of genetic abnormalities has continued into the new year, with Chinese life sciences company CapitalBio announcing recently the introduction of chromosomal microarray analysis services via its medical testing laboratories.
Separately, the firm also discussed its plans to open a new campus in China that will include expanded clinical testing, manufacturing, and R&D facilities.

Yimin Sun, director of life science services at the Beijing-based company, told BioArray News this week that the company is using a custom-designed, Agilent Technologies-manufactured comparative genomic hybridization array containing SNP content and markers specific to the Chinese population.

According to Sun, CapitalBio's array can be used to detect "both the chromosomal number and structural aberrations" that cause chromosomal diseases such as Down’s syndrome, Patau syndrome, Edwards syndrome, Prader-Willi syndrome, Angelman syndrome, cleft palate syndrome, Miller-Dieker syndrome, and non-balanced chromosomal translocations.

He added that the array can also be used to detect conditions such as loss of Y chromosome, which affects fertility, and other microdeletions and male infertility conditions, including Sertoli cell-only syndrome and total azoospermia. In addition to markers for detecting copy number changes, Sun said that there are more than 50,000 SNP markers on the array to detect conditions associated with loss of heterozygosity, such as uniparental dysomy.

Sun noted that CapitalBio selected the content for the array from several resources, including the International Standards for Cytogenomic Arrays consortium database, the Online Mendelian Inheritance in Man database, and the Database of Chromosomal Imbalance and Phenotype in Humans Using Ensembl Resources, or DECIPHER. In addition, CapitalBio consulted the Genetic Resource of the Chinese Population, China's national health and disease database. According to the firm, GRCP integrates several national genetic resources and physical data for human health science research and was developed by the country's Ministry of Education, Sichuan University, Central South University, and Xian Jiaotong University.

As the service has just been introduced, CapitalBio does not yet have enough information to comment on customer response to its offering, Sun said. At the same time, he described the Chinese market as "eager" for such a service.

According to the firm, about 5.6 percent of all newborns in China, or around 900,000 babies per year, suffer from some kind of birth defect. In addition, birth defects are responsible for about a fifth of infant mortality cases, and a tenth of childhood disabilities, annually. Taken together, CapitalBio projects healthcare costs associated with birth defects to be approximately ¥10 billion ($1.6 billion) per year.

New Chengdu Campus

CapitalBio's service is one of several available in China introduced to address these needs. In November, BioArray News interviewed Shanghai Children's Medical Center's Yongguo Yu about the introduction of CMA in China (BAN 11/27/2012). The Chinese University of Hong Kong also recently introduced CMA (BAN 7/10/2012).

But for CapitalBio, the addition of CMA to its testing menu is part of a larger effort to become a player in the country's clinical and consumer genetics markets, according to Keith Mitchelson, the company's vice president of international marketing and business development. Commensurate with that interest is a major facility expansion, he said.

Mitchelson told BioArray News recently that CapitalBio plans to open a new campus in Chengdu by the beginning of 2014. The 30,000-square-meter site will feature laboratories dedicated to clinical and consumer genetic testing, a manufacturing facility, and a biomedical R&D hub.
CapitalBio currently employs 750, mostly based at two sites in Beijing, Mitchelson noted. The firm has also maintained a 1,500-square meter medical laboratory in Chengdu since 2010, from which it offers more than 600 different assays.

While CapitalBio was founded as an array provider a dozen years ago, the technologies at its disposal have expanded in recent years as it looked to serve the growing Chinese clinical market. According to the company, it performs more than 10,000 tests per month, ranging from immunoassays to direct-to-consumer tests, and 2011 revenue from its lab was greater than ¥10 million ($1.6 million).
"When we started, we were making chips for the life science research market," said Mitchelson said. "We are still making these arrays, but we have just expanded to this new area," he said of the diagnostics market.

In comparison to the current Chengdu facility, CapitalBio's new lab will have three times the capacity and an increased range of analytical tests, with an emphasis on molecular diagnostic applications, according to the firm. CapitalBio said that it envisions the lab becoming the largest independent medical laboratory in the Sichuan province.

In addition to the new 10,000 square-meter laboratory testing facility, the manufacturing facility will be 15,000 square meters, and the industrial R&D hub will be about 5,000 square meters, Mitchelson said.

He added that the population density of the area is part of CapitalBio's rationale for locating its site in Chengdu. Located in southwestern China in the Sichuan province bordering Tibet, Chengdu is home to 10 million people; while Chongquing, another major city, is about 250 km from Chengdu.

"In that whole area, there are about 35 million people, so there is a huge population, and many, many hospitals," Mitchelson said.

The move to Chengdu is also part of a larger process of decentralization, which is encouraged by the Chinese government, he added.

"Everybody came to Beijing and Shanghai as China was opening up — all the multinational companies and Chinese companies, too — because the big business action was happening there, but now the Chinese government wants development outside [those areas], and Chengdu wants development," said Mitchelson.

"Also the cost of running a lab is very different in Chengdu compared to Beijing or Shanghai," he added. "And it's a well-connected international city now."

CapitalBio isn't the only life science firm looking to capture a piece of the growing Chinese clinical market. Shanghai Biochip, another firm that started out as an array vendor, will early next year begin accepting samples for various clinical tests via a subsidiary called Shanghai Biomedical Laboratory.

Huasheng Xiao, SBC's vice president, said in November that he envisions the Shanghai-based lab becoming a third-party provider of clinical testing services in China, akin to Laboratory Corporation of America or Quest Diagnostics in the US (BAN 12/18/2012).

At the time, Xiao said that SBC could introduce chromosomal microarray analysis in the future, but has decided that that such a test would require clearance from the China Food and Drug Administration, or SFDA, before SBC could make it available to its customers. He added that CMA is currently being offered mostly via hospital labs — and now CapitalBio — as a laboratory-developed test.

Before a test can be submitted for SFDA review, it must be cleared in the manufacturer's home country, Xiao noted. Affymetrix and Illumina, two of the firms that sell arrays for cytogenetic analysis, both intend to submit their tests to the US Food and Drug Administration this year (BAN 12/4/2012). Agilent has also discussed plans to a similar submission, but has not yet disclosed when it might seek such clearance (BAN 7/3/2012).

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