Walgreens Shelves Genetic Test

June 14th, 2010 | Sources: CNN

Responding to criticism from scientists and the FDA, Walgreens has postponed plans to market a personal genetic test kit made by Pathway Genomics

“We’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” a Walgreens statement said.

FDAhandcuffsThe Pathway Genomics kit uses saliva samples to assess one’s risk of contracting in excess of 70 diseases including lung cancer, hypertension and heart disease.

The kits cost $20. They include a plastic container, handy instructions and a postage-paid envelope to ship the specimen to a San Diego-based laboratory. Testing costs an additional $79 to $249.

The state-of-the-art in genomic science these days is that it’s easy and inexpensive to obtain genetic markers for a host of diseases, but there is insufficient data to give much credence to the findings…at least for diseases like cancer, diabetes and heart disease which are thought to be influenced by hundreds of different genes.

“Many of these markers are not understood, even what genes they are affecting right now,” Kenneth Offit, the chief of clinical genetics at Memorial Sloan-Kettering Cancer Center in New York told CNN. “It’s a very, very early stage in this level of genomic research.”

For its part, the FDA said, “Pathway Genomics has moved outside of the currently sanctioned boundaries for lab-developed tests by marketing (its) product in a retail store. These kits have not been proven safe, effective or accurate. Patients could be making medical decisions based on data from a test that hasn’t been validated by the FDA.”

Of note, Pathway Genomics has sold these kits online for the last 8 months. In fact, more than 30 companies offer personal genetic tests on line.


 

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