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Affymetrix, Roche File for US Clearance of Microarray-Based Diagnostic Products

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Affymetrix and Roche Diagnostics have separately filed for de novo 510(k) approval from the US Food and Drug Administration of their microarray-based diagnostic for drug metabolism, the companies confirmed last week for BioArray News’ sister publication GenomeWeb News.

Affy filed for clearance of its GeneChip 3000Dx reader, while Roche is seeking approval for its CYP450 AmpliChip. Both attained a Conformité Européenne Mark in early September for the microarray — the first product developed under their collaboration inked in Jan. 2003.

Spokespersons for Roche and Affymetrix confirmed that their companies had filed for FDA clearance, but neither would say when the filings occurred.

“We’re hoping to see clearance in 2005,” an Affy spokesperson told GenomeWeb News, referring solely to the GeneChip 3000Dx and not the actual AmpliChip. Affymetrix has continuously referred any questions regarding the AmpliChip to Roche.

Both firms had previously stated their intention to file for FDA clearance of their respective devices before the end of 2004.

Affymetrix’s GCS 3000Dx system comprises a GCS 3000Dx Scanner with AutoloaderDx, the FS450Dx fluidics station, and GCOSDx software. The system is an extension of Affy’s GeneChip platform that is used for gene expression and genotyping experiments, but it has been configured for diagnostic use.

Horst Kramer, head of media relations for Roche’s diagnostic division in Basel, Switzerland, told BioArray News in September that Roche is targeting peak global sales of roughly CHF100 million ($78.75 million) for the CYP450 test. Of that amount, Roche anticipates 40 percent will come from the EU, 40 percent will come from North America, and the rest from Asia and other markets (see BAN 9/8/2004).

The path to the US market has been tortuous for Roche, which has hit several roadblocks in its attempts to market an AmpliChip product. The firm had initially planned to sell the CYP450 chip as an analyte-specific reagent, but the FDA effectively quashed that plan in November 2003, when it said that the product may not enter the US market without agency premarket approval (see BAN 11/5/03).

— CW, EW

 

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