Roche microarray test cleared for Europe

Sept. 3, 2004 – A new microarray-based diagnostic test has been approved for sale in Europe, according to a news release. Switzerland-based Roche Diagnostics’  AmpliChip CYP450 Test has received the CE Mark, which certifies it has met health and safety requirements of European Union member states. The certification is necessary for products to be sold in Europe.

The AmpliChip, which is touted as the first chip-based test for broad diagnostic use, analyzes variations in two genes important in the metabolism of many widely prescribed drugs. Physicians can use the results for selecting drugs and individualizing treatment doses, the release said. The test combines Roche’s polymerase chain reaction amplification technology and Affymetrix Inc.’s (Nasdaq: AFFX, News, Web) microarray technology.

Santa Clara, Calif.-based Affymetrix also announced it has received CE marking for its GeneChip System 3000Dx instrumentation, on which the AmpliChip is run. GeneChip also is available for diagnostic use in the European Union.

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