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12:00 AM
Jul 21, 2003
 |  BioCentury  |  Politics, Policy & Law

FDA worries about Amplichip

A long-simmering debate at FDA over the best way to regulate microarrays has come to a boil with Roche Molecular Diagnostic’s decision to market its Amplichip CYP450DNA microarray without seeking prior approval from the agency. The Amplichip thus may become a test case for the agency’s rules on microarray diagnostics.

When Roche (SWX:ROCZ, Basel, Switzerland) launched the product last month, it asserted that the Amplichip initially would be sold in the U.S. as an analyte specific reagent (ASR) for use by laboratories certified as high complexity labs according to the Clinical Laboratory Improvements Amendment (CLIA) standard.

The ASR classification was created to allow the production and marketing...

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