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

23andMe Co-Founder and CEO Anne Wojcicki speaks onstage during TechCrunch Disrupt SF 2017 at Pier 48 on September 19, 2017 in San Francisco, California.

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, cardiology, and infectious disease.
On Wednesday, federal regulators gave the company the green light to offer such a 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 such a test.

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

The tests assess which genes are involved in breaking down various medications (including antidepressants and some heart medications) in the body. Versions 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 giving 23andMe permission to market the test, the FDA included several important caveats.

It said the new test "is not intended to provide information on a patient’s ability to respond to any specific medication," that the test doesn'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 breast cancer genetic screening, researchers called it "concerning" because it did not involve a genetics counselor who could explain to customers that the test only looked at 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 kit 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 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

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 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 the statement.

A 23andMe representative told Business Insider that the newest test would likely be incorporated into the company's existing health lineup, but could not yet provide details on cost. The existing lineup currently includes tests for Alzheimer's, Parkinson's, and breast cancer and retails for $199.

Color Genomics chose to incorporate its pharmacogenomics product into its existing lineup, which retails for $250.

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.

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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