Originally Published IVD Technology January/February 2004
INDUSTRY NEWS
OIVD concludes Roche chip not an ASRThe Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) issued a letter to Roche Molecular Diagnostics (Pleasanton, CA) regarding its AmpliChip CYP450. In this letter, OIVD stated that contrary to Roche's assertions, the AmpliChip cannot be classified as an analyte specific reagent (ASR) and therefore cannot be sold until it receives regulatory approval.
"OIVD believes that the intended use of the AmpliChip, to identify polymorphisms related to drug metabolism, is of substantial importance in preventing impairment of human health," said OIVD director Steven I. Gutman, MD, in the letter. "Even if the AmpliChip were to fall within the definition of an ASR, OIVD believes the technological characteristics of the AmpliChip would cause it to differ from existing or reasonably foreseeable ASRs, such that the AmpliChip would not be exempt from premarket notification. The AmpliChip cannot be commercially distributed without an appropriate premarket determination from FDA."
Gutman also suggested in the letter that if the AmpliChip is found not substantially equivalent, Roche should submit a premarket notification application and seek de novo classification. The AmpliChip's device classification would then depend on the outcome of FDA's premarket review.
Roche officials stated that the company plans to go through the proper regulatory channels to gain approval for the AmpliChip.
"Roche is pleased to have this opportunity to continue working with FDA to set the appropriate regulatory path for products in this new category," says Greg Heath, PhD, senior vice president of clinical genomics at Roche Molecular Diagnostics. "Roche has always stated its intentions to seek IVD status for the AmpliChip in the United States and Europe. We expect to submit our in vitro diagnostic application to FDA during 2004. However, at this time, Roche does not intend to pursue discussions with FDA for the microarray technology as it relates to the ASR regulation."
OIVD's decision regarding the Roche chip came as no surprise to industry analysts.
"The FDA letter is remarkable in that it does not mark any new policy initiatives or set a new threshold for defining the boundaries of an ASR as many in the IVD industry had speculated," says Thomas M. Tsakeris, president of Devices and Diagnostics Consulting Group Inc. (Rockville, MD). "FDA appears to believe that the current ASR regulation is sufficient to address the Roche AmpliChip situation by invoking the current ASR regulation and asserting that certain ASRs may not be exempt if they are viewed by FDA as extraordinarily affecting public health."
The Roche letter can be accessed via OIVD's Web site at www.fda.gov/cdrh/oivd/index.html.
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