This article has been updated from a version posted Feb. 16 to include comments from an Affymetrix official.
China's State Food and Drug Administration has cleared Affymetrix's GeneChip System 3000Dx version 2 for in vitro diagnostic use, Affy said last week.
The system is also cleared for IVD use in the US and Japan and has received a CE-IVD mark in the EU.
The SFDA's clearance could spur uptake of Affy's platform by Chinese clinical labs, and also shows that Chinese regulators have become more accepting of array-based diagnostics, according to Ruby Gadelrab, Affy's head of marketing and clinical development for international markets.
"Healthcare institute[s] in China were reluctant to invest in any array-based systems for diagnostics without SFDA clearance," Gadelrab told BioArray News this week. "The funding bodies had stipulated SFDA clearance before use for diagnostics." Gadelrab also said that SFDA clearance of Affy's system shows that the SFDA "sees the value in array-based diagnostics."
To date, Chinese clinical labs have only used Affy's system for research, Gadelrab said. The recent clearance enables these labs to "translate this research to actionable diagnostic tests that can fall into the reimbursement structure."
According to a company statement, there are more than 2,000 such clinical centers in China. The Santa Clara, Calif.-based microarray firm described China's molecular diagnostics market as the "fastest growing in the world" and said it represents a "significant growth opportunity" for the firm in Asia.
Two molecular diagnostics firms have already achieved US Food and Drug Administration clearance for tests that run on the GeneChip 3000Dx system: Roche gained FDA clearance for its AmpliChip CYP450 in 2004, and Pathwork Diagnostics obtained similar clearance in 2008. Another test, Skyline Diagnostics' AMLprofiler, achieved a CE Mark for clinical use in Europe last year (BAN 3/15/2011).
Altogether, Affy said that more than 10 tests are currently in development for use on its platform. In addition, the company intends to file its CytoScan array for clinical cytogenetics with the US FDA later this year (BAN 1/17/2011).
Gadelrab said there has been "significant demand" in China for tests that run on Affy's system, particularly in constitutional and cancer cytogenetics, pre-implantation genetic diagnosis, as well as non-cytogenetic tests for cancer and monogenic inherited diseases. She said that SFDA's recent clearance of Affy's system "paves the way" for clearance of other tests in the future, such as CytoScan.
Affy would also like to work with Chinese scientists to "develop tests or translate their existing signatures into tests which improve health and wellness," Gadelrab said.
According to Gadelrab, Affy has seen an interest in "applying genomics to new areas such as traditional Chinese medicine." She noted that in China's most recent five-year guideline, adopted last year, one of the initiatives is the "modernization and standardization" of traditional Chinese medicine. "We have seen a number of projects emerging which serve to understand impact on the genome of traditional medicines," she said.
Affy's rivals are also eager to tap into the Chinese molecular diagnostics market. In November 2010, Roche NimbleGen inked a deal with Beijing-based CapitalBio to enhance and automate Roche NimbleGen's array workflow for use in preventive and personalized diagnostics. Under that agreement, Roche and CapitalBio also agreed to establish educational facilities across China to support the adoption of tests based on Roche's NimbleGen arrays and 454 next-generation sequencing platform (BAN 11/16/2010).
Affy is looking to boost its presence in the world's second-largest economy. The firm maintains a representative office in Shanghai. CEO Frank Witney said in a recent earnings call that Affy has "very small efforts relative to [its] competitors" in China and has a "pretty extensive plan" to build up its resources in that country.
Though Witney characterized Affy's presence in China as "small," Gadelrab said that Affy has engaged Chinese researchers for years, noting the development of a Chinese population-specific array in 2010 (BAN 8/3/2010).
"There are 56 [ethnic] population groups in China," said Gadelrab. "We are keen to engage the community further to develop more ethnic-specific optimized research tools for these subpopulations," she said.
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