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Affy, Basking in AmpliChip Approval, Signs J&J Unit as IVD Customer

NEW YORK, Dec. 28 (GenomeWeb News) - Yesterday's US Food and Drug Administration approval of the AmpliChip is already paying dividends for Affymetrix.

 

Today, the Santa Clara, Calif.-based microarray giant said it has given a Johnson & Johnson company "long-term and comprehensive" access to its GeneChip technology to create and market in vitro diagnostics for certain undisclosed cancers.

The agreement gives Veridex non-exclusive rights to Affy's arrays and instruments. Financial terms of the agreement were not disclosed.

 

As GenomeWeb News reported yesterday, the FDA cleared Roche's long-awaited AmpliChip CYP450 DNA chip and Affy's GeneChip 3000Dx chip reader as an in vitro diagnostic.

 

The approval, announced in an FDA statement on Dec. 23, marks the first time that a DNA chip reader has won FDA clearance for IVD use. The agency also said the clearance may open the door for additional molecular diagnostics based on microarrays to be sold nationwide.

 

The chip and its reader were approved for sale in the European Union in September.

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