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Winning CE Mark, Jurilab s CYP450 Dx Faces Rivals, Murky Market; Firm Mulls FDA Move


Winning a CE Mark last week for its DrugMet drug-metabolism chip, Jurilab will try to stake a claim in an increasingly competitive — yet still undeveloped — market

Jurilab won the Mark a little less than a year after it had hoped to, and has not decided whether it might pursue clearance from the US Food and Drug Administration, Rebecca Maaranto, the company's vice president of marketing and business development for pharmacogenetics, told Pharmacogenomics Reporter this week. "This is something that will be reviewed on an ongoing basis, but it's not an immediate plan," she said. The company is evaluating the costs and benefits of that action, she added.

The European version of DrugMet tests for 27 polymorphisms in eight genes involved in drug metabolism: CYP450 genes 2D6, 2C9, 2C19, 2B6, and 3A4; NAT2; MDR1; and TPMT. The US research use-only product can test for 24 polymorphisms in seven genes — it is missing TPMT for intellectual property reasons. Nanogen, which bought a 25 percent stake in Jurilab in July, has rights to distribute the DrugMet array worldwide, with the exception of Japan.

Asked which medical discipline might find the test most useful, Maaranto said "there are obvious areas of interest from psychiatry and oncology" — two areas in which pharmacogenomics is widely believed to be able to make early gains.

"Broad adoption of pharmacogenomic tests is going to require more information about the best ways to make use of data, such as during dosage or therapy selection."

DrugMet could also play in drug development, although the product is best suited to clinical testing and late clinical trials due to the small number of highly clinically relevant polymorphisms for which it tests, according to Elaine Weidenhammer, associate director of strategic market development at Nanogen. "In Europe, [the target market] is a combination of clinical laboratories, as well as research laboratories and clinical research laboratories," she said.

Weidenhammer said Nanogen currently is not marketing the product to a particular treatment field in Europe. Since the test interrogates eight genes, the companies "believe that it offers a little bit more of a breadth of testing for people who want to do pharmacogenetic testing."

Similarly, Weidenhammer said she did not have an estimate of DrugMet's market size. "I think that broad-scale adoption is going to ramp up over time — but this is not going to be a billion-dollar market right off the bat."

The challenge of encouraging the healthcare community to adopt pharmacogenomic tests will require additional information about the best ways to use the test data, such as during dosage or therapy selection, said Weidenhammer.

A Growing Field, an Immature Market

At the moment, only Roche is approved to sell a drug-metabolism microarray as an in vitro diagnostic in Europe (as it is in the United States), but Tm Bioscience and Affymetrix have both announced intentions to attain regulatory approval for their products (see sidebar).

Jurilab's microarray can operate on "more or less any dual-channel scanner, so there's no major capital outlay," said Maaranto. By comparison, Roche's AmpliChip and Affymetrix' DMET require the use of Affy's GeneChip reader, while Tm Bioscience's tests, which run on the company's Universal Array, requires Luminex' X-Map reader.

The Jurilab system does not require a CE Marked reader in Europe, said Weidenhammer.

Jurilab continues to monitor SNP research and will consider adding new SNPs that are found to be clinically relevant, said Maaranto. The chip now tests for genes that the company considers to be most clinically relevant, she said.

By comparison, Roche's AmpliChip, which obtained its CE Mark in September 2004, tests for polymorphisms in two of those genes — 2D6 and 2C19.

"If you want to compete in 10 years, you want to be there now. For users, it's still some time to go."

Expectations for the CYP450 testing market have deflated during the last two or three years, and most people in the field are reluctant to estimate the market size, partly because of Roche's initially overoptimistic calculations. In November 2003, a Roche spokesperson said the product would generate $100 million in annual revenues by 2008, but when Roche's AmpliChip was awarded its CE Mark, spokesperson Horst Kramer estimated that the market would take about 10 years to reach that goal — more than twice as long as originally projected.

In a March interview with Pharmacogenomics Reporter's sister publication BioArray News, Heiner Dreisman, Roche Molecular Diagnostics' CEO, said about a decade must elapse before arrays in general are in widespread use. "If you want to compete in 10 years, you want to be there now. For users, it's still some time to go," he said.

Last August, Marcia Eisenberg, LabCorp's vice president overseeing research and development in molecular diagnostics, said demand for CYP450 testing is hampered by the lack of physician education on pharmacogenomics, although she said that FDA relabeling could have a positive effect on demand.

Jurilab CEO Kari Paukkeri said in August that the market for drug-metabolism diagnostics won't really pick up until the FDA requires drug makers to recommend such tests in drug labels.

Indeed, such a move by the agency could create a market relatively quickly. "Right now, the market is very small and I think we're just kind of in the throes of seeing the FDA weigh into cytochrome P450" as it examines warfarin's dosing recommendations, said Tm Bioscience CEO Gregory Hines, whose company plans to file with the FDA four CYP450 tests, one of which could help warfarin dosing. "We think there's lots of room for the growth of more than one company," he said in March.

Warfarin relabeling might also help Jurilab and Nanogen because the DrugMet chip tests for alleles of 2C9, the gene most responsible for warfarin metabolism.

— Chris Womack ([email protected])

Drug Metabolism Tests on Deck at the FDA

Jurilab and Nanogen are not the only firms seeking regulatory approval for an array-based drug-metabolism test. The growing queue at the FDA also includes Affymetrix, Tm Bioscience, and Osmetech.

Affymetrix' GeneChip DMET test interrogates "more than 150 genes," according to an Affy spokesperson. Before Affy acquired Parallele, which developed the chip, a company spokesperson said it tested around 170 polymorphisms in about 29 genes.

Affy has not announced whether it has filed the product for US or European clearance, although a spokesperson last year said the company intended to do so by March.

Tm Bioscience plans to submit four of its five CYP450 assays to the FDA for clearance this year, CEO Greg Hines said in March. Those tests include three single-gene tests and an assay that interrogates 2C19 and VKORC1 for guiding warfarin dosing, Hines said. Tm's three single-gene assays test for one each of the same alleles as Roche's AmpliChip CYP450.

Osmetech plans to submit a low-cost CYP450 assay to the FDA sometime in 2007, Bruce Huebner, the company's president, told Pharmacogenomics Reporter sister publication BioArray News in March. "We believe strongly that we've got cost-competitive advantages over that chip and that we are going to be able to make it less expensive and provide it as a cost-effective alternative," he said.

— CW

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