May 13, 2010

Walgreens Temporarily Halts Sale Of Genetic Test Kit

Walgreens says it will delay plans to sell genetic testing kits after the U.S. Food and Drug Administration (FDA) demanded proof that the kits have regulatory clearance or some reason why they should be sold without the agency's blessing.

On Wednesday, the FDA released a May 10 letter to privately held Pathway Genomics Corp over its saliva genetic testing kit saying it was "unable to identify" FDA approval for Pathway's Genetic Health Report.

Walgreens, the nation's biggest pharmacy chain, said on Tuesday that it planned to start selling Pathway's genetic testing kits to help people asses their risk for inherited disease, making it the first U.S. drug store to carry such products.

However, the company has now decided to put the kits on hold.

"In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we've elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter," Jim Cohn, a Walgreens spokesman, said in an e-mail to press on Wednesday.

Pathway said its personal genetic testing kit, the Pathway Genomics Insight Saliva Collection Kit, can be sold without FDA clearance because it is not intended for use in diagnosis, treatment or for the mitigation or cure of a disease.  These qualities would make it an in vitro medical device, which the FDA does regulate.

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

Customers could then go to the company's website to order a customized report about their genetic make-up, with prices ranging from $79 to $249.

The reports allow consumers to see information on over 70 health conditions, including a person's response to some prescription drugs, their propensity for disease and whether they could pass any inherited diseases on to their children.

Consumers are meant to use this information to be able to modify the way the live.

"The Genetic Health Report appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act," according to the letter signed by James Woods, deputy director of patient safety and product quality in the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.

Critics expressed concern over the sale of these type of test kits directly to consumers, saying such tests offer incomplete information and any results about disease risk, especially for incurable disease like Huntington's or Parkinson's, should only be done with counseling that clearly explains the limitations of genetic testing.

The American Clinical Laboratory Association urged on Wednesday for consumers to seek the guidance of their doctor or other health care provider before using direct-to-consumer genetic tests to ensure proper understanding of the results.

"Many direct-to-consumer genetic testing companies are not testing individuals for disease -- they are testing for the propensity of developing disease conditions," Alan Mertz, president of ACLA, said in a statement to Reuters.

"Although such testing can offer useful information, it requires clear and personal communication between patients and healthcare providers so that steps can be taken to limit the likelihood of developing disease and control its effects."

Scientists have a limited understanding of genes that contribute to complex disease like heart disease or diabetes, and several studies revealed that using genetic information is much less effective than factors like family history at predicting a person's risk of developing these diseases.


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