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Marketing Setbacks, Price Indecision Force Roche and Affy to Delay AmpliChip Launch

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Roche Molecular Diagnostics and Affymetrix have put on hold for at least four weeks the launch of their jointly developed cytochrome P450 multi-analyte diagnostic, according to a Roche official.

Certain “market-preparation” setbacks mean Roche’s AmpliChip product will roll out at the end of June instead of late May, said Tom Metcalfe, senior vice president of genomic and strategic business development at Roche Molecular Diagnostics. Metcalfe was at the IBC Molecular Diagnostics meeting in Boston last week.

Though he declined to say what kinds of issues were responsible for the delay, Metcalfe said one issue was that Roche and Affymetrix could not agree on what to charge for the chip.

“Certainly, by the end of next month, it will be commercially available” to CLIA-approved labs, Metcalfe said.

Soon after, Roche and Affy will apply for FDA approval for the AmpliChip, though Roche Diagnostics has not “yet mapped out … approval processing details yet,” said Metcalfe. He stressed that Roche has “a very good design file” that would allow it to submit the chip, whose components comprise software, hardware, and reagents. For the software and hardware side, however, “there’s still some ways to go yet.”

“We’re working together with Affymetrix to map that out,” Metcalfe said.

Once FDA approval has been secured, “the next step” will be to introduce the product to European regulators, which Metcalfe said Roche expects to undertake “sometime next year.”

It was unclear whether the delay would also set back the launch of similar diagnostics for human papilloma virus, cystic fibrosis, colorectal cancer, HIV, and leukemia. These products, which are also part of the Roche-Affy collaboration, were scheduled to roll out after the CYP450 chip went live, Roche Dx chief Heino von Prondzynski said in early May.

Metcalfe said Roche also intends to develop a similar diagnostic for solid tumors. He said that project would be a “logical offshoot” of an ongoing program with Affymetrix that aims at using the GeneChip platform to develop a “diagnostic panel” for leukemia and lymphomas.

The AmpliChip will be the first commercial product to come out of an R&D collaboration Roche and Affymetrix penned in January. The product, designed by Roche and manufactured by Affymetrix, is based on cytochrome P450 liver enzymes, which play a role in drug metabolism. Specifically, the AmpliChip queries the CYP2D6 and CYP2C19 genes. Arrayed at 20 microns, the chip probes for more than 30 polymorphisms in the CYP2D6 loci and two in CYP2C19, and it also detects inherited deletions or duplications.

The 30-member CYP450 family affects the metabolism of a quarter of all drugs. So far, scientists have identified 49 genetic variants that cause deviations in the structure or expression of these enzymes. This gene is involved in the metabolism of over 50 drugs — from cough remedies to antihypertensive agents.

Klaus Lindpaintner, who heads Roche Genetics and oversees the company’s Center for Medical Genomics in Basel, Switzerland, said that while he believes in the accuracy of the test, “We still don’t know what its efficacy will be in day-to-day medicine. How will it play in clinical responses and disease outcomes? We don’t know.”

Jorge Leon, president of Leomics Consulting, a molecular diagnostics-consulting firm in Princeton, NJ, believes the market for these tests when sold to CLIA labs is between $10 million and $20 million. But once the chip is approved and marketed to the big reference labs and hospitals systems, the market balloons to $200 million.

—KL

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