Sales of genetic testing kits delayed over questions about FDA ap - wave3.com-Louisville News, Weather & Sports

Sales of genetic testing kits delayed over questions about FDA approval

(NBC) - Walgreens will not begin selling personalized genetic test kits in its stores yet. The delay comes after the Food and Drug Administration began an investigation into whether the test kits should have gone through the FDA approval process.

For a few hundred dollars you can go online and buy a kit that will tell you everything you want to know and possibly, things you'd rather not know about your genetic profile.

"It might give me false concern, and it might be give me concern about things I cannot change," said one person.

The kits have been selling on the internet for a few years. Manufacturers say the tests will tell you if you carry certain genes associated with inherited diseases, such as Alzheimer's, diabetes and cancer.

"People should have a right to any kind of information about their health," said Jim Woodman of Pathway Genomics.

Earlier this week, the San Diego-based Pathway Genomics announced it would begin selling the first ever over-the-counter personal genetic tests in Walgreen's drugstores starting Friday, May 14. But that plan is now on hold.

Citing substantial public interest, the FDA launched an investigation into why the company did not seek FDA approval. Walgreens decided to delay selling the kits until the FDA and Pathway Genomics sort out what kind of regulation is needed, if any.

Even if the kits eventually do hit store shelves, consumers will be left wondering what to do with their genetic information. Could it cause a couple to decide against having children if they find out they are carriers for Cystic Fibrosis? Or could it be the motivation you've been looking for to adopt a healthier lifestyle?

Experts say that carrying a genetic mutation does not mean you will actually develop a disease.

"If you care about your future health, the message is eat well, exercise and have checkups," said Professor David Winickoff of the University of California Berkeley.

That is good advice no matter what's in your genes.

The Insight Saliva Collection kits from Pathway Genomics would have cost between $20 and $30 in stores. Depending on how much consumers wanted to know about their DNA, test results from the company would have cost between $80 and $249.

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