Originally Published IVD Technology March 2005
INDUSTRY NEWS
FDA approves Roche chip as IVD
Matt Grebow
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| The AmpliChip CYP450 by Roche Diagnostics (Indianapolis). |
IVD industry watchers have long believed that access to a standardized instrument platform and test format could provide the boost necessary to kick-start growth of the commercial market for molecular diagnostics. Despite great market prospects, however, no company has so far been daring enough to take the lead on commercializing such a product.
That equation changed in December 2004, however, when FDA cleared the AmpliChip CYP450 genotyping test by Roche Molecular Systems Inc. (Pleasanton, CA) for marketing, making the product the first DNA microarray test to receive approval as an IVD.
The AmpliChip identifies variations in the CYP2D6 and CYP2C19 genes (FDA approval for the latter came in January), which help break down drugs in the liver and can be used to gauge the metabolism of drugs such as antidepressants, antipsychotics, and beta-blockers. The test is designed to run on the GeneChip System 3000Dx, a microarray instrument platform manufactured by Affymetrix Inc. (Santa Clara, CA). The GeneChip System also received FDA clearance for diagnostic use in December 2004.
Roche initially released the AmpliChip CYP450 in the United States in June 2003, announcing its intention to sell the assay as a Class I analyte specific reagent (ASR), and thereby exempt it from premarket review. In October 2003, however, FDA’s Office of In Vitro Diagnostic Evaluation and Safety (OIVD) rejected the company’s claims on the grounds that the AmpliChip was both too sophisticated and too important to receive Class I exemption. A Roche spokesperson insists that the company had always planned to produce the AmpliChip as an IVD. The company says that it has remained in close contact with FDA throughout the approval process.
IVD industry analysts believe that FDA’s approval of the Roche chip suggests how the agency may judge similar diagnostics in the future. “FDA has now clearly drawn the line, stating that array products are too complex to be sold as ASRs. This should help the IVD manufacturing community better plan for its product development and clinical and regulatory pathways,” explains Emily Winn-Deen, PhD, vice president of strategic planning and business development at Cepheid Inc. (Sunnyvale, CA).
Even so, Winn-Deen points out that FDA’s policy still includes some inconsistencies. “There are a number of multiplex ASRs commercially available already which FDA has allowed to be on the market. So there is still a little uncertainty about exactly where the line is, and what makes a test too complex to be an ASR,” she says.
According to other industry analysts, the importance of the AmpliChip’s approval lies not necessarily in the specific genes that the chip can identify, but in the foothold it provides Roche in the potentially lucrative molecular diagnostics market. “The drug companies are not yet recommending that this type of testing needs to be done. It is up to the customer to decide how to use it,” says Richard Schifreen, PhD, director of technology and market development at Promega Corp. (Madison, WI).
Regardless, Schifreen thinks that establishing a microarray platform has significant implications in the IVD industry. “Someone has to put a product on the market to get things rolling. Roche is staking its claim to the real estate. Clearly, it’s there first, and the Affymetrix chip is a powerful tool. Roche has gone out early with a good product, which is a good place to be.”
While Roche estimates that it will reap annual revenues of more than $100 million from the AmpliChip by 2008, it is not resting on the potential of a single product. The company has indicated that it is actively developing additional tests for the microarray platform.
Copyright ©2005 IVD Technology
