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Genetic Tests To Be Sold At Walgreens

May 12, 2010

The US Food and Drug Administration (FDA) plans to look into US pharmacy chain Walgreens after the company announced it will start selling genetic testing kits to help people asses their risk of inherited diseases.

Walgreens said Tuesday it plans to begin stocking the kits this week. The kits are made by Pathway Genomics out of San Diego, California. The deal would be the first of its kind to put such tests in local pharmacies.

But according to the FDA, there is no record that the test kits have been approved or validated by the agency and it plans to look at any claims made by the company.

“If a company is making claims about a product that hasn’t been reviewed or validated by FDA, we want to make sure the information to consumers is accurate and the test will do what it says it will do,” said FDA spokeswoman Erica Jefferson in a telephone interview with Reuters.

Experts, for the most part, say that genetic testing kits do not offer completely accurate information, and any results about disease risks should only be given with genetic counseling that clearly explains the limitations of genetic testing.

The Pathway Genomics Insight Saliva Collection Kit, manufactured by Pathway, will be sold at many Walgreens locations nationwide, said Pathway in a statement. The kits will sell for $20 to $30 per kit.

The product contains a small saliva collection kit, instruction manual, and a postage-paid envelope that customers can use to send their sample back to a Pathway lab for analysis. Once analysis is complete, customers can go on the company website and order a customized report about their genetic makeup, which will cost between $79 and $249.

Walgreens said that FDA approval is not required for the product to be sold in its stores. The drugstore chain sells a number of other testing products such as pregnancy test kits, paternity kits and drug test kits.

“There are people who need or want to know more about their genetic history or their genetic makeup,” Walgreens spokesman Jim Cohn told Reuters.

The chain will not offer the product in New York stores where the state law considers such tests medical-based and not consumer-based.

Pathway said in a statement that the company follows all regulatory guidelines that apply to its products. FDA clearance is not required to sell the genetic testing kit in retail stores, the company said.

The test kits are not intended for use in diagnosis, treatment or for the mitigation or cure of a disease, which are regulated guidelines by the FDA.

“It does provide information that allows a person to learn about their health to make healthier lifestyle choices,” Pathway said.

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