23andMe Mail Order Gene Test Goes Forward

GeneTestThe mail order gene test by 23andMe which claims to be able to determine a person’s risk for various conditions – from a saliva sample – started selling again after the FDA told them to stop in November 2013:

23andMe Relaunches Lower-Risk DTC Genetic Tests, Medscape, 30 October 2015

I don’t understand who this test is for. It doesn’t look like Medicare or any other insurers cover it. They might cover some of the cost of follow-up genetic counseling but you’d have to have a more rigorous gene test performed first, and you’d have to have a medical reason to have it performed, not just curiosity. The government’s National Cancer Institute said:

[Direct-to-consumer (DTC) gene tests] have not yet been found to help patients and their care providers make health care decisions and, therefore, they are not a part of recommended clinical practice.

This seems to be some kind of curio for the privileged. Over 28% of people in Philadelphia live under the federal poverty line. Where would they find $200 in their budget to get their genes tested? And..

The FDA said that 23andMe must provide consumers with information on finding a board-certified clinical molecular geneticist — or an equivalent professional — for counseling, if they desire this help.

What if you desire this help but can’t afford it? Genetic counseling is not cheap.

It matters that not everyone can afford this test because the people behind genetic testing are claiming there’s a benefit in amassing a large DNA data base. When only the elite can access these tests, one must assume the data represent a select group, a sliver of the population, not a cross section.

Is there informed consent prior to taking the test? Is there assurance that the testee understands the risks?:

  • False positives/negatives
  • Discrimination by life insurance companies, health insurers, or employers
  • Emotional impact
  • Financial impact (increased doctor visits, scans, surgeries)
  • Social impact (discrimination)
  • How and to whom test results will be reported
  • Future use of test specimen or will it be destroyed? (You’re giving away a map of your DNA for free)
  • How environment, lifestyle choices (diet, smoking), family history impact risk and where genetic testing fits in

The test has been rolled back to return just carrier status for now but 23andMe is “trying to chart a comeback path for more of its health tests,” including cancer and Alzheimer’s disease.

1 thought on “23andMe Mail Order Gene Test Goes Forward

  1. Melinda

    We have gene tests for ancestry, but certainly not for medical conditions. Such things should only be done and interpreted by trained medical/genetic professionals.



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