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Whatman's Combichip Wins CE Mark Around Nine Months Later Than Expected

NEW YORK, (GenomeWeb News) – Whatman today said that its Combichip multiplex protein biochip has received CE registration as an in vitro diagnostic and will be available to reference labs as a CE-marked IVD kit.
 
The product, indicated for autoimmune diseases, won the agency’s approval around three months later than its most recent prediction, and around eight months later than it had originally expected it to become approved.
 
As reported by GenomeWeb News sister publication BioArray News, Whatman in August 2005 said it would launch the Combichip as an IVD by the end of that year. But in January officials pushed back that date to the first quarter of 2006.
 
In May Whatman filed the Combichip with European regulators and said at the time that it expected to win the CE Mark as early as June.
 
The Combichip requires a single, low-volume serum sample to generate results for 14 different analytes. It also reduces analysis time to two or three hours, Whatman said.
 
The assay system, developed in partnership with Privates Institut fur Immunologie und Molekulargenetik, currently identifies antibodies associated with approximately 10 different autoimmune diseases, including systemic and neonatal lupus and systemic sclerosis.

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