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Roche and Affy Win EU Approval for AmpliChip, Microarray Dx Platform

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Roche and Affymetrix announced last week that they had received European regulatory approval to market a microarray-based platform for in vitro diagnostic purposes as well as the first test to be used on Affymetrix’s system.

The CE mark, which was granted for both Affymetrix’s GeneChip System 3000Dx and Roche’s CYP450 test, marks an important milestone in the firms’ ongoing collaboration. Despite earlier setbacks, it also signals the beginning of a new era in molecular diagnostics, pushing the industry a step closer to personalized medicine.

Horst Kramer, head of media relations for Roche’s diagnostics division in Basel, Switzerland, said the firm expects to sell its first AmpliChip to the diagnostics market in one of the 25 EU countries in a couple of weeks.

Since the cost of an Affymetrix platform is more than most physicians’ offices can afford — Affy estimates the cost at €100,00-€150,000 ($120,850-$181,280) in Europe — the focus will be on selling to diagnostic labs, Kramer said. “Physicians can take a swab of saliva from the mouth of a patient and send it to one of these laboratories, and they will receive the information, whether this individual is a regular metabolizer, a fast, or rapid, or ultra-rapid metabolizer,” he said. That will help the physician determine for certain disease areas whether to apply the regular dose, a reduced dose of a drug, or an increased dose of a drug.

According to Santa Clara, Calif.-based Affymetrix, the GCS 3000Dx system comprises a GCS 3000Dx Scanner with AutoloaderDx, the FS450Dx fluidics station , and GCOSDx software. The system is an extension of Affy’s GeneChip platform that is used for gene expression and genotyping experiments, but it has been configured for diagnostic use.

Meanwhile, Roche’s AmpliChip CYP450 drug-metabolism test, which was anticipated to be the first test approved for use on the new platform, also received the CE mark last week. The test detects genetic variations in the cytochrome P450 2D6 and 2C19 genes and provides the associated predictive phenotype.

The 2D6 and 2C19 genes play an important role in the metabolism of many drugs — such as the anti-coagulant Warfarin, which has a complex dose-response relationship.

Both genes have amassed a body of scientific study, which is one of the reasons they were the first tests out of the gate. But Roche intends to roll out several more tests over the next couple of years, including AmpliChip tests for human papilloma virus, cystic fibrosis, colorectal cancer, HIV, and leukemia.

According to Kramer, Roche is targeting peak global sales of roughly CHF100 million ($78.75 million) for the CYP450 test. Of that amount, Roche anticipates 40 percent will come from the EU, 40 percent will come from North America, and the rest from Asia and other markets.

The firm believes that in approximately 10 years, AmpliChip products will be competing in a market worth an estimated $11 billion to $12.6 billion. It has stated in the past that it expects to ring up AmpliChip revenues of $100 million by 2008 — a figure that Kramer said he has “no reason to question.”

The path to the US market has been tortuous for Roche, which has hit several roadblocks in its attempts to market an AmpliChip product. The firm had initially planned to sell the CYP450 chip as an analyte-specific reagent, but the US Food and Drug Administration effectively quashed that plan in November 2003, when it said that the product may not enter the US market without agency premarket approval. (see BAN 11/5/03)

An FDA letter to Roche said that, based on a review of the company’s June 25, 2003, press release announcing the official launch of the AmpliChip CYP450 as an ASR, and other Roche materials, 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.

A Roche spokesperson in the US said this week that the firm definitely would not discuss any plans regarding the filing of the product in the US as an ASR. The company has been selling the CYP450 chip to drug makers for pre-clinical research since pulling it off the market as an ASR in the US, and Roche is expected to file for US approval of the chip as an in vitro diagnostic product before the end of this month.

Dirk Lammers, vice president of molecular diagnostics for Affymetrix, told BioArray News that the firm is “working very closely with the FDA to get the system cleared for IVD use in the US.” He did not provide an estimation of when the company would file for that approval.

But Lammers made clear that the firm would not make the new platform available for use with ASRs. “It is our understanding that the FDA does not regard ASR as an appropriate classification for microarray-based tests,” Lammers wrote in an e-mail responding to questions.

A person close to Roche Diagnostics had told BioArray News’ sister publication Pharmacogenomics Reporter in May that the firm’s “initial projections [to launch six AmpliChip products] have changed significantly” in favor of many high-profile products projected to launch over the next three years and beyond.

Greg Heath, head of clinical genomics and oncology at Roche Diagnostics, told Pharmacogenomics Reporter in May that the company had “revised expected product lists and timelines for the AmpliChip platform and, in some cases, have proposed different timelines or technology platforms for products in some of the therapeutic areas ... and are engaging in early development work” for other clinical areas. He did not offer specifics. (see PGx Reporter 5/20/04)

However, according to a slide presented during Roche’s R&D Day in May, the firm had been in the early stages of developing microarray-based diagnostics for breast cancer classification, osteoporosis, leukemia, and the early detection and classification of prostate cancer.

“Since many of these tests are in early development stages, it would be inappropriate to speculate on launch or file dates,” Heath wrote in an e-mail in May responding to questions.

Affymetrix announced its $70 million, 18-year AmpliChip agreement with Roche in January 2003. Under terms of the agreement, Roche paid a one-time fee of $70 million to Affymetrix and would pay additionally for chips, royalties, and milestones. While the announcement covered the entire collaboration, there are actually 14 separate agreements between the two companies.

Although Roche’s CYP450 test is the first to be made available for IVD use on the GeneChip platform, Affymetrix said the system will be available for and capable of running other genotyping and gene expression assays under development by Roche and other partners. Lammers also said that the firm is in discussion with other diagnostics firms regarding additional tests for the platform.

But the question for Affymetrix and Roche remains whether the market is ready for microarray-based diagnostic tests.

Jerry Willamson, former man-aging director at Pyrosequencing and cofounder of the biosciences consulting firm Beacon BioPartners, where he is managing partner, told Pharmacogenomics Reporter last week, “This has been the Holy Grail. The likes of Illumina, Luminex, and Affymetrix and other microarray companies have been pushing the hope that they’ll be able to get a highly reliable, useful, large-scale microarray into the clinical laboratory to be used for diagnostic purposes.”

“Are clinical labs ready for sophisticated microarrays?” asked Willamson. The market will likely answer that question over the next few years.

— EW

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