Medical Device Link.

Originally Published IVD Technology November/December 2004

INDUSTRY NEWS

The GeneChip System 3000Dx by Affymetrix Inc. (Santa Clara, CA) received a CE mark for IVD applications and can be used by clinical labs in Europe to analyze microarray diagnostics.

Affymetrix Inc. (Santa Clara, CA) launched its GeneChip System (GCS) 3000Dx, the world’s first microarray instrument system for clinical diagnostics, in Europe. In accordance with the IVD Directive, this system received a CE mark for IVD applications and can be used by clinical labs in Europe to analyze microarray diagnostics.

“Obtaining the CE mark for the GCS 3000Dx is a very important milestone for Affymetrix’s diagnostic business,” says Rob Lipshutz, senior vice president of molecular diagnostics at Affymetrix. “This allows us to make the instrument available to clinical laboratories in Europe as the platform to run microarray-based IVD tests. There is a worldwide market opportunity for these tests, and Europe certainly is an important market.”

The first available IVD assay that can be run on the GCS 3000Dx is the AmpliChip CYP450 test by Roche Molecular Diagnostics (Pleasanton, CA). This test looks for genetic variations that can affect drug efficacy and cause adverse drug reactions, and it is the first CE-marked microarray product launched through a partnership between Roche and Affymetrix.

With the release of the GCS 3000Dx, Affymetrix is working to develop a network of partnerships with other IVD companies to create array-based diagnostics in both the clinical and nonclinical markets.

“A growing community of IVD businesses have partnered with Affymetrix to develop additional diagnostic microarray tests,” says Lipshutz. “The availability of the GCS 3000Dx system offers all of our partners a regulatory-ready instrument system to develop innovative genotyping and gene expression array-based assays.”

Industry analysts say that it will be interesting to find out how the market responds to this system. Any such developments may resolve some long-standing issues regarding molecular diagnostics.

“The availability of this system will help answer the question as to the value clinicians see in applying pharmacogenomic testing to patient management,” says Richard Schifreen, PhD, director of technology and market development at Promega Corp. (Madison, WI). “This has been the subject of considerable discussion and conjecture. We should be able to readily track the adoption of this new technology and see where the market stands and how it grows.”

It is not surprising that Roche’s AmpliChip CYP450 is the first test that can be run on Affymetrix’s GCS 3000Dx, considering the relationship between Affymetrix and Roche. The two companies have a licensing agreement that grants Roche nonexclusive access to Affymetrix’s array and instrument technologies for up to 18 years. The goal of this alliance is to develop and to commercialize microarrays with both diagnostic and therapeutic applications for a wider range of disease areas.

The Roche AmpliChip CYP450 is also no stranger to the news. Last year, the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) issued a letter to Roche regarding its AmpliChip test. 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 in the United States until it receives regulatory approval.

“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,” said OIVD director Steven Gutman, MD, in the letter. “The AmpliChip cannot be commercially distributed without an appropriate premarket determination from FDA.”

Since the AmpliChip CYP450 does meet the regulatory requirements for a CE mark, industry analysts believe that this illustrates the significant differences in interpretation regarding ASRs between the regulatory systems in the United States and the EU. However, Roche officials said that the two situations are completely different.

“The CYP450 product that will bear the CE mark and be distributed in the EU is a test kit and not a reagent,” says a Roche spokesperson. “The main difference between the two regulatory classifications is that an ASR has no product claims, while an IVD product has performance claims associated with the labeling that accompanies the product.”

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