Why Drugstore Genetic Tests Upset the FDA

| May 15, 2010

On Tuesday, Pathway Genomics announced that their personal genetic testing kit (InsightTM Saliva Collection Kit) would soon be available at the pharmacy chain Walgreens. The next day, the FDA released a letter it had sent to Pathway Genomics on Monday saying hold on, there was no approval on record for Pathway's Genetic Health Report. By Thursday, Wallgreens announced that it was delaying the sale of the genetic testing kits.

What's going on and why?

Pathway's kit consists of a saliva collection kit, instructions, and an envelope for sending your sample back to the Pathway labs for analysis.  Once they have sent in their saliva, consumers are supposed to log on to the company's website (www.pathway.com) to order a customized Genetic Health Report for $79 to $249. The company can test for genetic markers which could indicate whether the person is at risk for about 70 health conditions, such as breast or prostate cancer, heart disease, diabetes, rheumatoid arthritis, or susceptibility to having an adverse reaction to some prescription drugs. 

A number of questions come to mind. How accurate are the tests? What does one do with the information that you are more likely to get Alzheimer's? What about genetic counseling?

On Wednesday, the American Clinical Laboratory Association (ACLA; www.clincal-labs.org) urged consumers to seek the guidance of their health care provider in the use of direct-to-consumer genetic tests to ensure proper understanding of the results and appropriate follow-up. "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. "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."

Why should the FDA have anything to say about a kit being sold at Walgreens?

According to the FDA letter to Pathway, "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." James Woods, deputy director of patient safety and product quality in the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety, went on to write, "We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance or approval number for the Genetic Health Report. We request that you provide us with the FDA clearance or approval number for the Genetic Health Report. If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us with the basis for that determination."

Although the FDA does not have regulatory influence over the promotion or advertising of medical devices (see our recent article on the FDA's "Bad Ad Program"), they do have regulatory power over firms that manufacture medical devices.

Are we getting ahead of ourselves in terms of "personalized" medicine? Although we have made considerable progress in determining what genes, gene variants, or even combinations of multiple gene variants might be predisposing us to certain health conditions, we still have a long way to go to understand the true cause and effect relationships. Interpretation of test results, and counseling to know how to use the results is needed. If we allow marketing of genetic testing services directly to consumers, thereby skipping the input of trained professionals who know how to utilize and interpret genetic tests for disease prevention or monitoring, we might just be making ourselves anxious for no reason. It's true that knowing about a predisposition to like type 2 diabetes could be beneficial because change in diet, exercise could help prevent or delay its onset. But in other situations, such as discovering that you may be more likely to get Alzheimer's Disease, which cannot yet be prevented, may not bring the peace of mind for which we search.

* * *


FDA letter

ACLA letter

FDA Regulation Guidance

Pathway Genomics press release

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