WASHINGTON -- Retail sale of an over-the-counter genetic test set to begin this month at thousands of American drug stores is "a bad idea in every way," a Southern Baptist bioethicist says.
Pathway Genomics of San Diego announced May 11 its personal genetic testing kits will go on sale in many of the nearly 7,500 Walgreens stores nationwide. The company's Insight Saliva Collection Kit will sell for $20 to $30.
Using the kit, a consumer can send a saliva sample to Pathway Genomics' laboratory, then go to the firm's website to order various reports that cost from $79 to $249. The firm says its testing will show a person's risks for such conditions as Alzheimer's disease, diabetes, multiple sclerosis, obesity and various types of cancer. It also can reveal a couple's prospects for producing children with genetic disorders such as cystic fibrosis, diabetes and Tay-Sachs disease, according to Pathway.
Direct sale of genetic testing to consumers is "just irresponsible," said C. Ben Mitchell, professor of moral philosophy at Union University in Jackson, Tenn.
"First, this particular test may be illegal, since it does not have [Food and Drug Administration] approval," said Mitchell, a consultant to the Southern Baptist Ethics & Religious Liberty Commission. "Second, the role of genetics and lifestyle is not sufficiently understood to help patients make reliable decisions. Third, the danger of misinformation means that some people will not see their physicians because they think they already know their genetic risks. Finally, who will protect the very sensitive genetic data that may be discovered through these tests?"
The director of Stanford University's Center for Law and the Biosciences expressed similar concerns. "It is reckless. Information is powerful, but misunderstood information can be powerfully bad," Hank Greely told The Washington Post.
The over-the-counter test could not only mislead consumers regarding health care choices, it could also cause couples to refuse to have children when the prospect of a genetic disorder is actually small or prompt them to abort a child after follow-up screening of the unborn baby, The Post pointed out.
The Food and Drug Administration acknowledged it has not approved the test and said it would investigate.
"We think this would be an illegally marketed device if they proceed," Alberto Gutierrez, director of the FDA's office of in vitro diagnostics, told The Washington Post. "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."
Pathway officials denied the kit requires FDA approval, since their lab will perform the analysis, according to The Post.
The various genetic reports to be offered by Pathway, and their pricing, are: (1) Responses and unfavorable reactions to various drugs for $79; (2) risks for various health conditions for $179; (3) status of a couple as possible carriers of gene mutations that can cause disorders in their offspring for $179, and (4) a combination of all three for $249.