Regulators just gave DNA testing startup 23andMe the go-ahead to offer a health product that scientists have called dubious

  • Anne Wojcicki, the CEO and founder of genetics testing startup 23andMe, said earlier this month that she hoped the company would add a new health offering that looks at how you process medications, including those for depression.
  • On Wednesday, federal regulators gave the company the green light to offer the test.
  • Albertsons pharmacies and gene testing startup Color Genomics offer the same type of test for $250-$750, but many scientists say it’s not worth the money.

Anne Wojcicki, the CEO and founder of popular Silicon Valley gene testing company 23andMe, said earlier this month that she didn’t feel like the company was currently offering what she called a “complete product.”

That’s because the current gene testing kit — which includes health screenings for some of the genes involved in Alzheimer’s, Parkinson’s, and breast cancer — did not include a test that looks at how you process medications, including those for depression.

But on Wednesday, Wojcicki’s company got the green light from the Food and Drug Administration to sell the test.

The tests assess which genes are involved in breaking down various medications (including antidepressants) in the body. They are currently being offered by psychiatrists and Albertsons pharmacists in three major cities at a hefty price tag of $750. Just last month, another Silicon Valley genetics testing startup called Color Genomics began offering the test as part of its $250 kits. 

Many scientists feel the tests don’t offer a clear benefit to people and say that in many cases they are not worth the money. Among other issues, the tests may give conflicting results to the same patient for the same medication and don’t tell providers which specific medication is best, according to experts.

In its authorization announcement, which stated that 23andMe had permission to market the new test, the FDA included several important caveats.

For example, the new test “is not intended to provide information on a patient’s ability to respond to any specific medication,” the authorization read.

‘When we can bring pharmacogenomics back, then we have a complete product back’

23andMe kitIn the early days of 23andMe, the company included a test for depression medications in its lineup of health offerings, Wojcicki said. But in 2013, the FDA forced the company to stop selling those products and get federal approval on the grounds that the tests could be misinterpreted as health advice. The company was allowed to continue selling the genealogy component of its kit, which looks at ancestry.

Last year, the FDA gave the company the green light to again sell some of its health screenings. On the heels of that decision, 23andMe rolled out a limited selection of some of its original products. The most recent addition, unveiled in March, is a test for some of the genes involved in the risk of developing breast cancer, also known as BRCA genes.

Now, the company was only missing one of those original health products, Wojcicki said earlier this month: a test for medications, also called pharmacogenomics.

“The only one we don’t have back yet is pharmacogenomics. We used to have that and we’d like to have that one come back,” Wojcicki said at a panel discussion at the Rock Health Summit in San Francisco.

“When we can bring pharmacogenomics back, then we have a complete product back,” she added.

What the FDA approved

It remains to be seen how the company will roll out the new pharmacogenomics test to customers. Because 23andMe sells its tests directly to people (they can be purchased online and at a selection of drug stores), it needed to get FDA approval first.

That happened on Wednesday.

“This test is a step forward in making information about genetic variants available directly to consumers and better inform their discussions with their health care providers,” Tim Stenzel, a director in the FDA’s Center for Devices and Radiological Health said in a statement. 

The test could be incorporated into the existing health lineup, which currently includes tests for Alzheimer’s, Parkinson’s, and breast cancer for $199, or it could be sold as a stand-alone test.

Color Genomics chose to incorporate its new pharmacogenomics product into its existing $250 test. But unlike 23andMe, which sells its services directly to consumers, Color requires people to order their tests through a medical provider. In addition, the company mandates talking with a professional genetics counselor and a clinical pharmacist to avoid potentially dangerous misinterpretations of the results.

Genomind and Assurex, the two companies who offer a standalone pharmacogenomics product, sell the test through psychiatrists and some pharmacists for $750.

Wojcicki did not provide further details on how much the test would cost or when it would be available. A company representative also declined to offer Business Insider more information about the test. But Wojcicki said she saw the pharmacogenomics service as part of the company’s overall mission to help empower customers with more data about themselves and prevent negative health outcomes when possible.

“I think one thing genetics can do is help prevent a lot of early deaths,” Wojcicki said.

Still, the FDA’s Tim Stenzel offered caution for people who get the test:

“This test should be used appropriately because it does not determine whether a medication is appropriate for a patient, does not provide medical advice, and does not diagnose any health conditions.”

SEE ALSO: DNA tests that cost as much as $750 claim to tell you which antidepressant is best for you, but scientists say they’re not worth the money

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