The recent explosion of interest in the stock of genomics companies begs the question of whether a viable business model for consumer genomics is around the corner.
A recent CNN poll uncovered that 61 percent of the persons surveyed would like to know if they are genetically predisposed to a particular disease. By offering patients such predictive disease information, a genomics company could obtain patient specimens, genotype them and offer them (with the patient's consent) to drug companies for use in clinical trials or other research programs.
Alternatively, a genomics company could sell consumers genotype data relating to their own health status, alerting them to diseases to which they may be predisposed, to diseases they may have before symptoms appear, or to drugs for which they may have an adverse reaction.
Millennium Predictive Medicine Inc., a subsidiary of Millennium Pharmaceuticals, is focused on such linkages between the consumer and genomic research.
Another Massachusetts company, Genomics Collaborative, recently signed a deal with AmeriPath to acquire samples of normal, diseased and cancerous human tissue along with blood samples and clinical information for use in its tissue repository. Genomics Collaborative is enrolling 7,000 patients per month worldwide to fuel its genetic association studies focused on 10 disease areas.
Finally, DNA Sciences Inc. solicits members of the public over the Internet as part of its Gene Trust Project. Through its DNA.com Web site, DNA Sciences obtains personal and family health profiles from individuals (which it pledges to keep confidential), and if a profile matches one of the company's disease-associated genotype database needs, that individual will be asked to donate a blood sample. In this manner, DNA Sciences hopes to gather large numbers of patients for similar disease association studies.
By going directly to patients and obtaining informed consent by asking patients to click through a Web-base consent form, DNA Sciences has been criticized (perhaps unfairly) for not going through the normal intermediary of a doctor or clinical investigator.
Genomics Collaborative's patients go through an informed consent process with their physician. The traditional informed consent obtained in a hospital or doctor's office setting, however, is hardly foolproof, as the recent problems with gene therapy and other clinical trials have shown.
While it is clear that the data obtained using these approaches will have considerable value in drug discovery, the truly interesting question is whether such data will provide the basis for a business in consumer genomics.
DNA Sciences has allied with the largest and most popular consumer healthcare Web site, Healtheon/WebMD, as a way of aggregating patients for its research. The Healtheon/WebMD deal provides DNA Sciences with access to select populations of people - many of them with specific diseases and the majority of them interested in proactively managing their conditions or otherwise exploring alternative treatments.
The real goal appears to be to aggregate patients so as to create unique, long-term relationships with them, thereby establishing a solid linkage for purposes of selling and distributing genomic information and related products. The value proposition offered by DNA Sciences is early disease detection and more precise diagnostics.
While DNA Sciences' plans have been met with some skepticism, it is worth noting that the same skepticism was focused on direct-to-consumer tests for diagnosing HIV. However, these tests were eventually sold and the controversy has largely disappeared.
Still, a host of ethical and legal issues remain to be navigated:
Can consumers give a truly informed consent for genetic testing if even the genomics company collecting the information can't say what samples today may be used for tomorrow?
If the patient submits a sample, giving a general release to the genomics company, and the sample eventually tests positive for a fatally incurable disease, does the genomics company have an obligation to tell the patient?
If a doctor is not in the middle of the process, what guarantees can there be that the sample will meet quality control standards?
And, most importantly, how can companies prevent the misuse of test results, such as accidental leaks to employees or health care payers (who may require the disclosure of all test results before providing insurance)?
It may be the case that the best route directly to the patient is through pharmaco-genomics, namely uncovering linkages between mutations in certain genes and the response of a patient population to a specific drug. Companies like Genaissance and Massachusetts-based Variagenics hope to make a profitable business of helping drug companies tailor therapies to those patients who are most likely to benefit from a particular drug.
Without the Internet, no one would be talking about consumer genomics. However, like drugstores on the Internet, consumer genomics is likely to be a much more complex business than it seems at first glance.
As Drugstore.com and PlanetRx.com have struggled with reimbursement problems and access to customers, the new consumer genomics programs must solve the ethical, legal and reimbursement issues involved in direct-to-consumer genetic testing.
As consumers take more responsibility for their own health care, scientific advances may permit the advent of truly personalized medicine, thereby overcoming these obstacles and becoming an important outgrowth of the revolution in genetic discovery.
Reprinted with permission. All rights reserved. Mass High Tech - October 2-8, 2000.
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