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Concerns Raised About Drugstore Genetic Test

FDA Is Looking Into Claims About New Genetic Test Kit
By
WebMD Health News
Reviewed by Laura J. Martin, MD

May 13, 2010 -- Walgreens has postponed its plans to sell an over-the-counter genetic test due to FDA concerns that "consumers are putting themselves at risk if they use a test not approved" by the federal agency.

The test, offered by Pathway Genomics, already is offered online. So are similar tests from other companies. None have FDA approval, but the FDA has not previously intervened.

"FDA believes we have regulatory authority over these laboratory-developed tests, but we recognize we have not always used this authority," FDA spokeswoman Erica Jefferson tells WebMD.

Now Pathway's planned retail sale of the test has attracted FDA attention.  The agency has sent an enforcement letter to Pathway, asking the company to tell it why it does not think it needs FDA approval to sell the test.

"We don't have any record of this test being submitted for approval or clearance, so we will look at claims being made," Jefferson says. "It is a process where we consider a number of different options. We want to make sure information given to consumers is accurate and that any product is going to do what it says."

Pathway Genetic Test

The Pathway test does not sequence a person's entire genome, but instead looks for the most common single-letter genetic code variations (single nucleotide polymorphisms or SNPs) linked to disease risk, medical conditions, and sensitivity to certain drugs.

According to the Pathway web site, the tests report some of the genetic risks for 61 medical conditions and sensitivity or predisposition to adverse events for eight drugs.

The test kit will sell for between $20 and $30 at 7,500 Walgreens stores across the U.S., with the notable exception of New York, which has a law blocking sale of the test. But the kit isn't the whole cost. Pathway will offer kit buyers Drug Response results for $79, "Pre-Pregnancy Planning" results for $179, "Health Conditions" for $179, or a combination of all results for $249.

The kit contains a small saliva collection tube and a postage-paid envelope for customers to send in their samples for testing at Pathway's lab. Customers then go online to a password-protected site to see the results.

Genetic counseling is available at a price. It will cost $40 for a call of up to 20 minutes, and $99 for an hour of counseling, although Pathway will not charge for counseling calls it makes to customers to warn them of particularly troubling test results.

Only adults will get their full test results. If a parent sends in a child's saliva for testing, Pathway will report only those risks that affect childhood health. When the child reaches age 18, he or she can then ask Pathway for the full report.

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