Company plans to sell genetic testing kit at drugstores
Tuesday, May 11, 2010
Beginning Friday, shoppers in search of toothpaste, deodorant and laxatives at more than 6,000 drugstores across the nation will be able to pick up something new: a test to scan their genes for a propensity for Alzheimer's disease, breast cancer, diabetes and other ailments.
The test also claims to offer a window into the chances of becoming obese, developing psoriasis and going blind. For those thinking of starting a family, it could alert them to their risk of having a baby with cystic fibrosis, Tay-Sachs and other genetic disorders. The test also promises users insights into how caffeine, cholesterol-lowering drugs and blood thinners might affect them.
The over-the-counter test marks the first foray of personalized genomic medicine into the corner drugstore. The move is being welcomed by those who hope that deciphering the genetic code will launch a new era in biomedical science.
But it's being feared by those who worry it will open a Pandora's box of confusion, privacy violations, genetic discrimination and other issues.
The new test comes as federal regulators, bioethicists, geneticists, doctors and patients have been increasingly struggling with how to use, interpret, regulate and guard against abuse from the flood of genetic information, tests and technologies being developed because of the massive, government-sponsored Human Genome Project.
For years, companies have been hawking tests on the Internet that can analyze genes for a person's risk of some diseases, and genetic tests for paternity and ancestry have been widely available in stores.
But the plan being announced Tuesday by Pathway Genomics of San Diego to sell its Insight test at about 6,000 of Walgreens' 7,500 stores represents the boldest move yet to bring the power of modern molecular medicine to the mass market.
"It's the first widespread retail availability of genetic tests that are directed specifically at health issues," said Joan A. Scott, director of the Genetics and Public Policy Center at Johns Hopkins University.
The Food and Drug Administration questioned Monday whether the test will be sold legally because it does not have the agency's approval. Critics have said that results will be too vague to provide much useful guidance because so little is known about how to interpret genetic markers.
"It doesn't seem like a good use of resources or something people should be spending their money on yet," said Sharon F. Terry, who heads the Genetic Alliance, a Washington-based coalition of patient groups, researchers, private companies, government agencies and public policy organizations.
Others have said that the test is irresponsible and could give many buyers a dangerous false sense of security or, conversely, needlessly alarm them.
"It is reckless," said Hank Greely, director of Stanford University's Center for Law and the Biosciences. "Information is powerful, but misunderstood information can be powerfully bad."