Affymetrix and Roche Diagnostics have each filed products comprising their CYP450 AmpliChip microarray for US Food and Drug Administration approval as a de novo 510(k) in vitro diagnostic, Pharmacogenomics Reporter has learned.
The CYP450 microarray is comprised of Affy’s GeneChip 3000Dx reader and Roche’s CYP450 AmpliChip, both of which attained a Conformité Européene Mark in early September.
A Roche spokesperson confirmed the company had filed the AmpliChip with the FDA.
“We’re hoping to see clearance in 2005,” an Affy spokesperson told Pharmacogenomics Reporter. He was talking about the reader and not the actual AmpliChip.
Neither Affy nor Roche would say when they filed their products with the FDA.
The filing makes good on the company’s stated intention to file the device before the end of 2004. Roche also intended to file its corresponding AmpliChip CYP450 microarray for approval before the end of the year.
Horst Kramer, a Roche spokesperson, told Pharmacogenomics Reporter in September that the company will release more chips in “two to three years’ time,” but he declined to number them. Future chips would be produced for “differential diagnoses for various kinds of cancer,” including leukemia, breast cancer, lung cancer, and colorectal cancer (see Pharmacogenomics Reporter, 9/9/2004).
In May 2003, the company said it planned to release as ASRs six diagnostics products in the space of 18 months based on Affymetrix’ GeneChip platform (see Pharmacogenomics Reporter, 5/20/2004). The CYP450 chip would have been the first AmpliChip sold to diagnostic laboratories this way, but the company abandoned the route under pressure from the FDA, which suggested Roche apply for IVD approval by the de novo 510(k) path.
Both Affy and Roche attained the European Union’s CE Mark for in vitro devices in early September. The CE Mark mostly shows compliance with quality systems standards. Those standards have a large overlap with those of the US and, like the situation with many ASRs, the many CE Marks for in vitro devices do not require the kind of scrutiny that comes with filing for FDA approval, such as a de novo 510(k), Bill Pignato, an independent regulatory affairs consultant, told Pharmacogenomics Reporter.