Capping a turbulent year for Roche Diagnostics and its AmpliChip CYP450 product, European regulators last week gave the green light for the company to begin selling the drug-metabolism test as an in vitro diagnostic in the 25 nations of the European Union.
Compared to the prominent announcements Roche produced at the beginning of its failed attempt to market AmpliChip as an analyte-specific reagent last year, the firm took a more subdued approach to the product’s Conformité Européenne Mark, which it quietly announced in a Sept. 1 statement on its website.
Also that day, Affymetrix, Roche’s partner in the development of the AmpliChip product, said EU regulators approved its GeneChip reader, and the company said the day before that its microarray manufacturing facilities had earned certification from the International Organization for Standardization.
The Swiss diagnostics giant plans to file AmpliChip with the US Food and Drug Administration before the end of the month.
The long-expected entry of the AmpliChip into the in vitro diagnostics marketplace will begin in one country, followed by the rest of Europe “in the next couple of weeks,” said Horst Kramer, head of media relations for Roche’s diagnostics division in Basel, Switzerland. He estimated the chip’s unit price at about €400 ($480), saying this cost may differ in other markets.
Affymetrix Vice President of Molecular Diagnostics Dirk Lammers said in an e-mail to BioArray News, Pharmacogenomics Reporter’s sister publication this week, that the Santa Clara, Calif.-based company’s GCS3000Dx Scanner, which will read the AmpliChip, will cost “between €100,000 [$120,000] and €150,000 [$180,000] in Europe.”
“We assume that there should be [worldwide] sales in the dimension of about 100 million Swiss Francs [$79 million]” for the CYP450 AmpliChip in a couple of years, said Kramer. Roche expects the drug-metabolism assay market to split with 40 percent in Europe, 40 percent in North America, and the remaining 20 percent in Asia and other markets, he said.
He said this number depends on whether the AmpliChip gains approval from the FDA, and on whether other countries’ regulatory agencies follow suit. He was not willing to speculate about the current worldwide size of the CYP450 AmpliChip’s market.
AmpliChip’s CE mark may also open the door to other molecular diagnostic companies currently developing similar chip-based IVDs. But the market itself will not open up immediately, Kramer conceded: The worldwide microarray IVD market could reach fruition in the space of perhaps 10 years, he said. “We are pretty keen to have an adequate share of that market,” he added.
“It’s nice to see them do that,” said Greg Hines, CEO of Tm Bioscience, commenting on the AmpliChip’s European approval. Hines said Tm Bioscience will soon sell its Tag-It P450 assays as ASRs in the United States, joining a number of companies currently selling P450 ASRs. Because ASR requirements and those of the CE Mark are similar, said Hines, he was optimistic that companies using the ASR route in the US could qualify for the CE Mark.
No CYP450 chip-based IVD is currently approved in the United States, and Roche ceased marketing as an ASR its CYP450 AmpliChip last year [see 11/6/03 PGx Reporter]. Since Tm Bioscience does not market its CYP450 product in Europe, Hines said his company does not yet compete directly with Roche. Tm Bioscience, which is based in Canada, is ready to market its product as an ASR in the US, but may opt for IVD filing near the end of the year, after the FDA releases its final genetic testing guidelines, he said [see 5/23/03 PGx Reporter].
Another potential Roche competitor, Finnish pharmacogenomics company JuriLab, hopes to obtain a CE Mark for its DrugMEt CYP450 assay, which is currently sold to drug-developers, sometime in the first half of 2005. Nora Kaarela, vice president of business development and head of pharmacogenetics and diagnostics, said she welcomes Roche’s precedent, especially at a time when manufacturers and regulators are still fine tuning guidelines.
Roche has had its own share of fine tuning. In May 2003, the company said it planned to release as ASRs six diagnostics products in the space of 18 months based on Affymetrix’ GeneChip platform [see 5/20/2004 PGx Reporter]. The CYP450 chip would have been the first AmpliChip sold to diagnostic laboratories this way, but the company abandoned the route under pressure from the FDA. The agency suggested Roche apply for IVD approval by the de novo 510(k) path.
Roche intended to file for IVD approval for these products in the US (and the European Union) by the end of 2004. This was the case even after the FDA wrote Roche in Oct., 2003, that the company would need to file premarket notification for AmpliChip [see 5/20/2004 PGx Reporter].
But in May, Greg Heath, head of clinical genomics and oncology at Roche Diagnostics, wrote in an e-mail to Pharmacogenomics Reporter that “product lists and timelines” for the AmpliChip had been revised [see 5/20/2004 PGx Reporter].
Timelines for the other AmpliChip products have been scaled back, and product lists have become less specific. Kramer, the spokesperson, said more chips would be released in “two to three years’ time,” while he declined to number them. Future chips would be produced for “differential diagnoses for various kinds of cancer,” including leukemia, breast cancer, lung cancer, and colorectal cancer.
The CE Mark for in vitro devices mostly shows compliance with quality systems standards. Those standards have a large overlap with those of the US and, like the situation with many ASRs, the many European in vitro device CE Marks do not require the kind of scrutiny that comes with filing for FDA approval, such as a de novo 510(k), according to Bill Pignato, an independent regulatory affairs consultant.