The FDA and Hereditary Cancer Testing

DNA, DNA chart

credit: Flickr Micahb37

The intersection of genomics and consumers was on full display last week when the FDA handed down a strongly worded letter telling to stop selling their $99 DNA test which, among other things, tells recipients about their disease risk.

Possible results include your risk for hereditary cancers.  “The agency says that customers may make health decisions such as prophylactic breast removal surgery as a result of 23andMe’s report on their genetic risk for breast cancer,” wrote MIT Tech Review.  The problem is, the company hasn’t handed over any of the requested data to the FDA to prove that their testing is actually accurate.

About 50% of men and 33% of women will develop cancer at some point in their lifetime.  Of that number about 5% to 10% are hereditary cancers.  To be given genetic information without any physician support could leave a consumer (now patient) scared, confused and making inappropriate decisions.

Top types of hereditary cancer

Cancer risk varies greatly depending on where it is in the body.  Hereditary cancer is most likely in the following areas …

  • Breast cancer
  • Colorectal cancer
  • Ovarian cancer
  • Prostate cancer
  • Endocrine cancer

Angelina Jolie stirred debate when she got tested and confirmed for the BRCA gene.  Her decision was prophylactic breast removal and soon after surgery, she lost an aunt to breast cancer.  You can certainly understand why she made her decision when she did.  The genetic test can run as high as $3,000 and is not always covered by insurance, leaving many women vulnerable to the disease and without the ability to determine if they are at risk.  A $99 alternative is definitely a bargain, provided the information is accurate.

The FDA made it clear that they had not heard from 23andMe since May but that they had seen them begin a heavy marketing campaign touting the products abilities.  Did the company sink their own ship by not cooperating with the FDA?

23andMe said in a statement, ““We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

Clearly if the FDA was trying to get their attention, they succeeded.  Now it’s up to 23andMe to appease the FDA and get their revenue stream back, a very tall order, especially as they ease into the January resolution season when many consumers might be looking for this kind of information.

Should genetic testing be allowed outside a doctor’s office?

But should we have genetic testing without physician input?  What if a consumer received information that sent them to the internet for a cure that wasn’t appropriate?  What if there were medical consequences from taking bad advice?

You can see where the snowball effect can really kick in.

What do you think, should genetic testing be a consumer product or something that is supervised through physicians?

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