When Brian Van Ness spoke in June at the Beyond Genome meeting in San Francisco, the University of Minnesota genetics researcher suggested that third-party prescription guides might improve physicians’ understanding of existing pharmacogenomic technologies, and therefore increase their uptake in the clinic.
But that might be easier said than done.
Two commercial services currently provide guides to help doctors make pharmacogenomic-based prescribing decisions: a dosage-estimating database from Genelex called GenMed Rx, and a research-referring database from Seryx called Signature Genetics.
Both methods analyze information about current patient treatments and patient genotypes to direct doctors to drug doses that are more likely to be appropriate for an individual patient.
Genelex and Seryx both report that demand for their services is growing, but the approach has not yet broken into the mainstream. The few clinicians who are using these services are generally psychiatrists, and even among that group, the guides – and pharmacogenomics in general – are the exception rather than the rule.
Although the need for these services may be apparent to observers like Van Ness, demand may not be high enough to support new companies entering the pharmacogenomic guide market.
Genelex performs genetic testing using Tm Bioscience’s Tag-It platform for drug-metabolism enzymes, and the firm produces prescription recommendations for particular drugs based on genotype, polypharmacy interactions, and physical characteristics of the patient.
The company, which began the service in 2000, produces about 100 reports per month, according to spokesperson Kristine Ashcraft.
Initially, most of Genelex’s business came via the firm’s Internet-based direct-to-consumer sales and marketing, and that trend continues to this day, although clinicians, especially psychiatrists, have begun to be more interested in the service, said Ashcraft. “Up until about six months ago I’d say that about 100 percent [of testing] was for consumers,” she said. By last month, about 80 percent were consumers and 20 percent were physicians, she added.
Because third-party payors sometimes reimburse for pharmacogenomic tests, Genelex provides to its physician customers the CPT codes that are also used by insurers for disease-related genetic testing, she said.
Seryx’ Signature Genetics, launched in September
, is very similar, but instead of issuing dosage recommendations directly, its reports refer clinicians to journal articles with information about drug interactions and dosage recommendations.
Like Genelex’ service, Signature Genetics also bases its report on drug metabolism-enzyme genotype data and physical and existing pharmacological factors.
Requests for Genelex’ GenMedRx reports more than doubled in one year from 40 per month in 2004 to 90 reports per month in 2005, Ashcraft said.
LabCorp signaled its interest in Seryx’ service when it began offering Signature Genetics along with its own menu of products in early May
Seryx markets Signature Genetics primarily to psychiatrists, and as of mid-June
the company had fulfilled 487 total orders for reports for doctors involving about 45 drugs, yielding an average of about 60 per month.
Psychiatrists are a “crowd that's got a will and an interest to incorporate pharmacogenetic testing into their practice," Reggie Downey, Seryx’ CEO, said last August
During a sabbatical in 2005, Van Ness, who is head of the department of genetics, cell biology, and development at the University of Minnesota, examined the commercialization of genetic testing to guide clinical medicine.
As part of his market analysis, Van Ness interviewed physicians to find out what they know about genetic testing. With the exception of psychiatrists, who seemed to be more familiar with the potential of pharmacogenomics, “if they graduated from medical school more than about a year [before], and I said ‘SNP’ or ‘genetic variation,’ [most] didn’t have a clue — they didn’t know what I was talking about,” he said.
One barrier to physicians adopting pharmacogenomics is the time and effort involved — “wading through all that information to figure out what’s good, bad, or indifferent,” said Van Ness.
If the difficulty in keeping current with developments in pharmacogenomics is holding physicians back, it would seem reasonable that the market for interpretation services, such as those provided by Genelex and Seryx, might support more than two small companies. But newcomers don’t appear to be rushing into the field.
Wolters-Kluwer, a medical information, publishing, and tools company, has the potential to enter that market, but it has no plans to.
The firm’s Fact and Comparison database seems like it would lend itself to pharmacogenomic dosage recommendations — the database delivers drug-drug interaction and dosage information based on clinical data that doctors feed into it. Fact and Comparison is similar to Genelex’ service but without the genomic component.
“We certainly talked about this,” said Bryce McMurray, head of new product development for Wolters-Kluwer’s pharma solutions division, but he said that the company doesn’t see enough demand to justify a pharmacogenomic interpretation product for another five to 10 years.
The company keeps track of the contents of drug labels in its R&D Insight database, and when the number of labels with pharmacogenomic information hits a critical mass, Wolters-Kluwer may consider offering such a product, he said. He did not elaborate on the number of drug labels that would have to contain pharmacogenomic information.
“If they graduated from medical school more than about a year [before], and I said ‘SNP’ or ‘genetic variation,’ they didn’t have a clue — they didn’t know what I was talking about.”
Another factor preventing companies from introducing these services is the high complexity of the genetics of drug reactions, said McMurray. Rather than DNA-based testing, which is what Genelex and Signature Genetics offer, this kind of service will probably ultimately rely on gene-expression or other biomarker data to estimate proper doses, he said.
Without basic knowledge of genomics, physicians have been particularly cautious about possible snake-oil salesmen, said Howard Coleman, president and CEO of Genelex. “When we started doing this in 2000, we got almost no calls — doctors would say, ‘This is of no value — this is quackery,’” he said.
That may not be surprising, since Genelex is currently offering a direct-to-consumer nutrigenetic product made by Sciona that was singled out last week as an example of genetics-based marketing “snake oil” by the chairman of the US Senate Special Committee on Aging
Some of that suspicion also stems from overly eager researchers, however, and they may hold the key to fixing the problem, said Van Ness. “I think there are a lot of hokey associations out there that people are trying to hype,” he said. “You don’t have a lot of clinical trials and validations [for] genetic tests to go with a particular therapeutic, and I think that there is the lag period.
“Right now, a lot of [clinical research has] to happen so that physicians are aware — and then public policy and third-party payors are going to jump in on it,” he added.
According to Coleman, it soon may become more difficult for physicians to distinguish among trustworthy and untrustworthy services. “We’re going to see a stampede of hucksters into the DNA testing field in the next year or two,” he said.