FDA, Walgreens Puts Pathway Genetic Test Sales on Hold

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Walgreen’s drug stores originally had plans to launch the retail sale of an at-home genetic test on Friday that allows the consumer to assess his or her risk for diseases such as breast cancer, heart disease, and Alzheimer’s. The nation’s largest drugstore chain has opted to put sales on hold after an FDA warning that the test is not approved and could put consumers at risk.

The test requires FDA authorization because it involves a device that allows consumers to collect their own DNA. The agency is also concerned about the fine line between medical diagnostics and simply providing consumer information.

FDA spokeswoman Erica Jefferson has said, “We don’t have any record of this test being submitted for approval or clearance, so we will look at claims being made. We want to make sure information given to consumers is accurate and that any product is going to do what it says.”

Jim Cohn, Walgreen’s spokesman said, "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," said Jim Cohn, a Walgreens spokesman.

The Pathway test, called Insight, is already offered online as are similar tests. Recently, actress Glenn Close had her genome sequenced by a company called Illumina, which was a more in-depth study of the structural characteristics of the DNA, such as deletions and rearrangements. Her desire to take the test stems from a family history of mental illness, according to the Huffington Post.

The test kit, made by Pathway Genomics, consists of a saliva collection tube and a postage-paid envelope for customers to send their samples to the Pathway lab for testing. At the lab, the test does not sequence a person’s entire genome, but instead looks for the most common genetic code variations, called single nucleotide polymorphisms or SNP’s, that are linked to disease risk, medical conditions, and sensitivity to certain drugs.

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According to the company website, the Pathway test will report the genetic risks for about 61 medical conditions and predisposition to adverse events for eight drugs. Only adults can get their full results from the test. Children under 18 will only receive those risks that affect childhood health.

Jeffrey Vance MD PhD, chairman of genetics at the University of Miami Miller School of Medicine, said in an interview with WebMD that the Pathway tests is probably accurate because it is not sequencing the entire genome. This means that the test can most likely accurately identify common variations on a gene, but cannot give information about rarer variations that would also increase risk.

Should the test pass FDA approval, Walgreen’s will sell the test for between $20 and $30, except in the state of New York, where laws already block the sale of the test. However, that isn’t where the cost to the consumer ends.

In order to receive results (online), the consumer must choose one of the following packages: “Drug Response” results for $79, “Pre-Pregnancy Planning” for $179, and “Health Conditions” for $179. Receiving all results will cost $249.

* Genetic Testing to Help Dieters Lose Weight

Genetic counseling for positive results is also available at a cost of $40 for a 20 minute call or $99 for an hour.

Should you purchase a genetic test for personal health risks, what will you do with the results? The point of the test is to identify risk for certain health conditions which are not controllable so that you can take action on the lifestyle habits that are in your control. Genes are only part of the equation for good health. For example, if the test tells you that you are susceptible to diabetes, you should work harder to maintain weight with a healthy diet and regular exercise and ask your doctor about fasting blood sugar tests at annual physicals.

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