FDA to look into gene tests to be sold at Walgreen

CHICAGO Tue May 11, 2010 5:02pm EDT

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CHICAGO (Reuters) - U.S. pharmacy chain Walgreen Co plans to start selling genetic testing kits to help people assess their risk for inherited diseases in a move that has already drawn the attention of federal health officials.

Walgreen said on Tuesday it plans to start stocking gene testing kits this week made by Pathway Genomics, a start-up company based in San Diego. The deal with Pathway would make it the first to put such tests in the local pharmacy.

But the U.S. Food and Drug Administration says it has no record that the test kit was approved or validated by the agency and plans to take a hard 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," Erica Jefferson, an FDA spokeswoman, said in a telephone interview.

Many experts say genetic testing kits offer incomplete information, and any results about disease risk, especially for incurable diseases such as Huntington's or Parkinson's, should only be done with genetic counseling that clearly explains the limitations of genetic testing.

Several companies -- including Decode Genetics' DeCodeME based in Iceland, 23andME in which Google has invested, and privately held Navigenics -- sell tests that allow people to learn if they have inherited risk for disease.

Pathway said in a statement its personal genetic testing kit, the Pathway Genomics Insight Saliva Collection Kit, will be sold at many of Walgreen's nearly 7,500 stores nationwide, for $20 to $30 per kit.

It contains a small saliva collection kit, instructions, and a postage-paid envelope that customers can use to send their sample back to the Pathway lab.

Then, consumers go on the company's web site, www.pathway.com, to order a customized report about their genetic make up, with prices ranging from $79 to $249.

Walgreen said FDA clearance is not required to sell the kit in its stores. The drugstore chain already sells other diagnostic and testing products such as pregnancy tests, paternity tests and drug tests.

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

The chain will not sell the tests in the state of New York because of a state law that considers them medical tests, and not consumer information.

Pathway said in a statement the company follows regulatory guidelines that apply to its products.

"FDA clearance is not necessary to sell the Pathway Genomics Insight Saliva Collection Kit in retail," the company said.

It said the tests are not intended for use in diagnosis, treatment or for the mitigation or cure of a disease -- qualities that would make it an in vitro medical device, which the FDA does regulate.

"It does provide information that allows a person to learn about their health to make healthier lifestyle choices," the company said.

(Additional reporting by Jessica Wohl in Chicago, editing by Philip Barbara)

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