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

By Katie Drummond | AOLNews.com


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.

Its 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

"Were revolutionizing the way people access information about their genetics, and through thousands of convenient Walgreens locations, were making it easier and more affordable than ever before to order a personalized genetic report," Jim Plante, Pathways 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 Alzheimers, multiple sclerosis and breast cancer. It can be analyzed to determine a persons predisposition to blindness and obesity, as well as the odds that a users baby could be born with cystic fibrosis or more than 30 other genetic disorders.

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

But results wont be at your fingertips. After paying $20 to $30 for the kit, a user submits the saliva sample to Pathways 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 hasnt 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 its too soon to be interpreting genetic markers.

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

Company representatives say theyre 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 agencys Alberto Gutierrez told Business Week.

Pathways test is nothing new, but its marketing strategy is. Thats the real rationale behind the worry, according to Newsweeks Mary Carmichael.

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

Article from: AOLNews.com




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