Washington Post: Company plans to sell genetic testing kit at drugstores
The Washington Post reports on a development that could affect individual privacy: over-the-counter genetic testing kits.
[S]hoppers 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 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. [...]
In response to a query from The Washington Post, an FDA official said that the agency planned to investigate the test.
“We think this would be an illegally marketed device if they proceed,” said Alberto Gutierrez, director of the FDA’s office of in-vitro diagnostics. “They are making medical claims. We don’t know whether the test works and whether patients are taking actions that could put them in jeopardy based on the test.”
Company officials said the test does not require the agency’s approval because the analysis will be done at the company’s lab.
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