The US Food and Drug Administration has summoned Heinrich Dreismann, the general manager for Roche Molecular Diagnostics, to come to the agency to discuss why the company is marketing its AmpliChip microarray as an analyte specific reagent.
Steven Gutman, director of the Office of In Vitro Diagnostic Device Evaluation and Safety, of the agency's Center for Devices and Radiological Health, issued what is termed an untitled letter to Dreissman at the Pleasanton, Calif., headquarters of Roche. The letter was delivered by overnight courier and a copy of the communication was posted on the FDA website. An FDA spokeswoman confirmed the veracity of the letter and the delivery to BioArray News on Thursday.
In the agency's regulatory methods, an "untitled letter" is an informal and advisory communication not quite as severe as a "warning letter," which is also informal and advisory in nature. Warning letters are issued for violations of regulatory significance - offenses that may lead to agency enforcement action if not promptly corrected.
The letter does illustrate the gulf that lies between microarrays as a research tool, and the promised land of clinical diagnostics. The AmpliChip stands as an important initial step toward a time when microarray chips are used in every doctor's office to do a quick gene-expression profile for diagnostic or treatment purposes.
The agency apparently takes issue with statements made in a June 25 press release issued by Roche Diagnostics at the official launch of the AmpliChip CYP450, a microarray of its own design, manufactured by Affymetrix.
"We would like to invite you to come in to discuss the basis for your apparent conclusion that this microarray is properly regulated under the analyte specific reagent provisions of FDA regulations, 21 CFR 864.2020," the letter said.
If the device is an ASR, then it is not subject to FDA pre-market review requirements.
However, the letter said that on review of the press release and other Roche materials, that the AmpliChip is not a reagent, but a multi-signal device, and one that is intended for use with a specific configuration of a proprietary accessory, the Affymetrix microarray platform. Therefore, the letter said, the AmpliChip is an assembled device that is part of a specific test system.
If this is the case, it would be subject to the agency's pre-market review.
"They are not saying that our conclusions are not appropriate," said Christiane Koesling, a Roche spokeswoman, "but they would like to discuss it. We look forward to working with the FDA."
Roche has placed a $70 million bet on the Affymetrix platform, announcing an 18-year licensing agreement with the Santa Clara, Calif., microarray giant in January, and then just months later, launching its first product, the CYP450 chip, to be sold in the US as an ASR, with the promise of more to follow.
Before the product launch, the company told BioArray News (Roche Reshapes Affy's GeneChip As AmpliChip: Readies a CYP450 ASR) that it intended to seek FDA approval for the product, but that it did not want to delay making it available to reference labs. The company did, however, miss its originally targeted May date for release.