The Business of Genetic Testing

The December issue of Scientific American features a story by Laura Hercher, faculty member in the Joan H. Marks Graduate Program in Human Genetics at Sarah Lawrence College, probing the growing business of direct-to-consumer genetic testing. Hercher focuses the article on “nutrigenetics:” a new industry offering billed as personalized nutritional advice based on the results of a genetic test combined with a lifestyle questionnaire. But Hercher cautions that commerce may be running ahead of science, stating that “the commercialization of gene detection technology has occurred before scientists have developed an adequate understanding of how particular genes contribute to health and disease.”

Government and consumer advocacy groups have expressed skepticism about nutrigenetics. The U.S. Government Accountability Office, Hercher writes, testified before Congress on the results of a sting operation that nutrigenetics companies “mislead consumers.” The GAO study, based on a sting operation, revealed that despite the emphasis on genetic testing, the advice was based on the questionnaire, no matter what DNA sample accompanied it.  In addition, a number of companies were using genetics and the allure of personalized medicine as a hook to market overpriced vitamins and supplements.

Nutrigenetics is only a small part of the larger field of genetic testing, and Herscher is concerned that “the thin foundation of science that underlies these new tests may have repercussions for the broader field…” Many tests, she says, are not looking for genes that result in diagnosing disease but rather are predictive of whether a person is likely to develop a disease sometime in their lifetime. Those tests, coupled with guidance from a genetic counselor, can help individuals make difficult decisions. “The genetics community worries that Internet nutrigenetic tests may dampen public faith in the validity of those more legitimate tests,” she writes.

The lack of regulation of nutrigenetic tests is of great concern to Hercher. “In the U.S., the FDA regulates few of the 1,000 or so genetic tests on the market for safety and effectiveness,” and concludes that: “If misused, nutrigenetics can undermine the faith of a public primed to expect great things from the Human Genome Project. If it provides the impetus for credible, reliable regulation of genetic testing, however, it will promote the legitimate efforts of science and industry to turn research straw into clinical gold.”

Laura Hercher’s article.