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Affy to Launch Clinical Lab Business in 2007, Breaks Ground on New Manufacturing Plant

SAN FRANCISCO, Jan. 10 (GenomeWeb News) - Affymetrix will open a clinical lab business next year with an eye toward growing its molecular diagnostics business, CEO Stephen Fodor said yesterday at the JPMorgan Healthcare Conference, held here this week.


Affymetrix Clinical Laboratories will be based in Sacramento, Calif., and will develop CLIA-certified tests for diagnostic partners based on the firm's GeneChip technology. Fodor said the tests would enable partners to get their assays on the market quicker than developing tests that have to be cleared by the US Food and Drug Administration's 510(k) process.


In addition to the clinical lab business, Fodor said Affymetrix has broken ground on a new microarray and reagent-manufacturing facility in Sacramento that is expected to open in 2007.


The firm had some problems with manufacturing capacity during 2005, which partially contributed to a shortfall in fourth-quarter and full-year revenue. In response to those difficulties, Affymetrix expanded its capacity 30 percent during the fourth quarter of 2005, and company officials said the firm would expand manufacturing capacity an additional 30 percent during the first quarter of 2006.


Affymetrix officials also noted at the conference that the firm is leasing a manufacturing facility in Singapore to make instrumentation and they expect to begin manufacturing there in the second half of 2006. The facility is part of Affy's early efforts to expand its operations in Asia. Those plans include setting up offices in Shanghai and collaborating with state labs in China.

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