Genetic Testing Kit to Hit Drugstore Shelves
2010-05-12 0:00

By Katie Drummond |

Some 6,000 drug stores in the U.S. will begin selling a genetic testing kit Friday, marking a milestone in access to the rapidly evolving world of personalized, DNA-based medical care.

It’s the first time a genetic test will be sold over the counter, and it is not happening without some controversy.

The product, called Insight, was developed by San Diego-based Pathway Genomics. Pathway, like several other companies, already sells similar genetic tests online. But the company, a start-up, is hoping that a savvy sales strategy can boost its numbers.

A lab technician tests DNA samples at Pathway Genomics Corp. in San Diego, Calif. The company is preparing to sell gene-testing kits in Walgreens stores next week, a step likely to generate questions about how consumers may use and understand test results that many doctors have trouble interpreting.Sandy Huffaker, Bloomberg / Getty Images

"We’re revolutionizing the way people access information about their genetics, and through thousands of convenient Walgreens locations, we’re making it easier and more affordable than ever before to order a personalized genetic report," Jim Plante, Pathway’s CEO, said in a statement.

The test, which uses a saliva sample provided by the consumer, is being marketed as a simple way to evaluate the risk of developing illnesses such as Alzheimer’s, multiple sclerosis and breast cancer. It can be analyzed to determine a person’s predisposition to blindness and obesity, as well as the odds that a user’s baby could be born with cystic fibrosis or more than 30 other genetic disorders.

Insight also evaluates one’s sensitivity to dozens of substances and medications, including caffeine and blood thinners.

But results won’t be at your fingertips. After paying $20 to $30 for the kit, a user submits the saliva sample to Pathway’s research lab, where DNA is evaluated and results are available online -- for a fee. The company is selling three different results packages, which range from $79 to $179.

Not everyone is greeting the arrival of the product in retail stores with enthusiasm. The Food and Drug Administration is already questioning the legality of the move because it hasn’t approved the test. FDA officials now plan to investigate further.

Other experts worry that the test will offer nothing more than false hope or needless alarm, because it’s too soon to be interpreting genetic markers.

"It is reckless," Hank Greely, director of Stanford University’s Center for Law and the Biosciences, told The Washington Post. "Information is powerful, but misunderstood information can be powerfully bad."

Company representatives say they’re marketing the product as a means of encouraging healthy lifestyle changes. But because some of the tests touch on such personal issues -- whether to have a child or obtain a recommended medical exam -- some critics say the results risk skewing decision-making toward recklessness or unnecessary caution.

Tests that "could lead to a consumer making a decision on whether they are going to terminate a pregnancy -- we consider that a very important decision to be made on a test that has not been looked at by the FDA," the agency’s Alberto Gutierrez told Business Week.

Pathway’s test is nothing new, but its marketing strategy is. That’s the real rationale behind the worry, according to Newsweek’s Mary Carmichael.

Those who’ve bought genetic tests online are "a selective group," who know what they’re getting into. By going retail, "the only prerequisite for coming across [Insight] and buying it is that you’re a person who shops at Walgreens," she writes.

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