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

Steve Jennings/Getty Images for TechCrunch23andMe’s founder and CEO, Anne Wojcicki.
  • Anne Wojcicki, the CEO and founder of the genetics-testing startup 23andMe, said a few weeks ago that she hoped the company would add a new health offering that looked at how customers processed medications, including those for depression, cardiology, and infectious disease.
  • On Wednesday, federal regulators gave the company the green light to offer such a test.
  • The next day, experts from the same agency warned people against taking similar tests from other companies because they “may not be accurate.”
  • Albertsons pharmacies and the gene-testing startup Colour Genomics offer the same type of test for $US250 to $US750, but many scientists say it’s not worth the money.

Anne Wojcicki, the CEO and founder of the popular Silicon Valley gene-testing company 23andMe, said in mid-October that she didn’t feel as if the company was offering what she called a “complete product.”

That’s because its latest 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 looking at how customers processed medications, including those for depression.

But on Wednesday, Wojcicki’s company got the green light from the Food and Drug Administration to sell such a test. The next day, experts from the same agency warned people against using similar tests “whose claims have not been reviewed by the FDA.”

23andMe’s test is the first of its kind to get FDA clearance to be sold directly to consumers online or in stores. Several other similar tests are on the market, but all require the involvement of a physician or a psychiatrist.

The tests assess which genes are involved in breaking down various medications (including antidepressants and some heart medications) in the body. Versions are being offered by psychiatrists and Albertsons pharmacists in three major cities at a hefty price tag of $US750. Just last month, another Silicon Valley genetics-testing startup, Colour Genomics, began offering the test as part of its $US250 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 giving 23andMe permission to market the test, the FDA included several important caveats.

It said that the new test was “not intended to provide information on a patient’s ability to respond to any specific medication,” that the test didn’t provide medical advice, and that patients should check with their doctors before stopping medications.

Scientists have previously warned customers against using other 23andMe services. In the spring, when the company began offering its genetic screening for breast cancer, researchers called it “concerning” because it did not involve a genetics counselor who could explain to customers that the test looked at only a small number of the genetic variants involved in the disease.

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

23andMe kitLydia Ramsey/Business Insider

In 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 earlier this year, 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 in October: 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 a few weeks ago.

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

What the FDA approved

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 before marketing its latest test.

That happened Wednesday.

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

Then on Thursday, experts from the agency warned people against taking other, similar tests that have not received FDA approval.

Specifically, the agency described tests “that claim to predict how a patient will respond to specific medications” and continued to say those claims “may not be supported by scientific and clinical evidence and may not be accurate.”

A 23andMe representative told Business Insider that its newest test, which did receive FDA approval, would most likely be incorporated into the company’s existing health lineup. The person could not yet provide details on how much the new test would cost. Along with its genealogy service, the company has health tests for Alzheimer’s, Parkinson’s, and breast cancer that sell collectively for $US199.

Colour Genomics chose to incorporate its pharmacogenomics product into its existing lineup, which retails for $US250.

But unlike 23andMe, which sells its services directly to consumers, Colour requires people to order their tests through a medical provider.

In addition, the company mandates talking to a professional genetics counselor and a clinical pharmacist to avoid potentially dangerous misinterpretations of the results.

Genomind and Assurex, the two companies that offer a standalone pharmacogenomics product, sell the test through psychiatrists and some pharmacists for $US750.

In its authorization statement, the FDA included the following caveats about 23andMe’s new product:

  • It is “not intended to provide information on a patient’s ability to respond to any specific medication.”
  • It “does not describe an association between the detected variants and any specific drug nor whether a person will or will not respond to a particular drug.”
  • “Health care providers should not use the test to make any treatment decisions.”
  • “Results from this test should be confirmed with independent pharmacogenetic testing before making any medical decisions.”

23andMe did not provide further details on when the newest test would be available to customers. Earlier this month, 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 Stenzel offered caution for people who choose to take 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.”

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