Dive Brief:

• 23andMe has won FDA authorization for a direct-to-consumer genetic test designed to show a patient’s ability to metabolize certain medicines. The test, the first of its kind approved by FDA, looks for 33 genetic variants linked to medicine metabolism in spit samples provided by consumers.

• In authorizing the product via the De Novo pathway, FDA placed special controls on the test, including a requirement that the label features a warning statement about how consumers should respond to the results. The agency warned that consumers and doctors should not rely on the test to make treatment decisions, saying results should be confirmed with independent pharmacogenetic testing.

• A day after announcing the clearance, FDA drug center chief Janet Woodcock and device center head Jeff Shuren warned about genetic tests claiming to predict how patients will react to a specific drug. "Tests that make such claims that have not been evaluated by the FDA and are not supported by prescribing recommendations in the FDA-approved drug label, may not be supported by scientific and clinical evidence, and may not be accurate," they said.

Dive Insight:

The agency seems to be seeking more authority, amid a proliferation of genetic tests marketed to consumers.

The FDA sent a safety communication Thursday to physicians and patients warning about the danger of relying on genetic tests making claims about patient response to an individual medication that have not been reviewed by FDA. It adding it would take action against test developers that sell genetic tests that make such claims. Specifically, the agency warned about genetic tests that claim to predict the effectiveness of depression medicines.

For its part, 23andMe has spent the five years since the FDA hit it with a warning letter working to get regulatory clearance for the genetic health information it used to provide to consumers. That process led to De Novo filings covering carrier status, genetic health risk reports and certain BRCA1 and BRCA2 variants.

The latest clearance allows 23andMe to provide consumers with information about whether they have certain genetic variants associated with differences in how medicines are metabolized. This phenomenon, known as pharmacogenetics, is well established, but patients typically only discover how their bodies react to a particular drug after they start taking it.

To get FDA to sign off on the test, 23andMe presented data on its accuracy and the ability of users to understand and appropriately act on the results. The company said 97% of consumers understood that they should talk to their doctor before making changes to the drugs they take. FDA drove home the importance this point in its statement about the approval.   

"This test ... does not determine whether a medication is appropriate for a patient, does not provide medical advice and does not diagnose any health conditions. Consumers should not use this test to make treatment decisions on their own," Tim Stenzel, director of FDA's Office of In Vitro Diagnostics and Radiological Health, said in a statement.

FDA expects patients to discuss their results with healthcare providers, who should confirm them with independent clinical pharmacogenetic testing before making medical decisions. These caveats and other requirements are baked into the authorization of the test through eight special controls.

Still, some questioned the utility of the test. 

Too many studies report that X 'predicts' or 'is predictive it's Y when all that is demonstrated is statistically significant association. That's too confusing when others study the predictive ability of X. Let's call it what it is.

association ≠ prediction https://t.co/EcIdzn4HF8

— Cecile Janssens (@cecilejanssens) October 28, 2018

Having bounced back from the warning letter, 23andMe thinks it is now in a position to question the regulation of other companies. CEO Anne Wojcicki used the news to call for all consumer genetic health tests to follow the FDA review process and face the same scrutiny as her company.

"It is concerning that the FDA is not requiring all direct-to-consumer genetic testing services to meet the high bar for analytical validity, accuracy or user comprehension, which 23andMe does," Wojcicki said in a statement.

It appears that FDA agrees: Shuren and Woodcock warned that FDA review of pharmacogenetic tests is critical to ensure patient safety, and its safety communication warned that physicians changing medications without proper FDA study could endanger patients.

"It is important to note that there are some drugs whose use can be aided by the results of pharmacogenetic information. In those cases, there is scientific evidence to support relationships between the genetic variant and how a patient responds to a drug, which has been reviewed by the FDA. The FDA-approved labeling for such a drug and genetic test provide health care providers with adequate information on how to use genetic information reported by the genetic test to manage medication treatment using the drug," Shuren and Woodcock wrote.

FDA has issued warning letters to other direct-to-consumer testing companies, including a provider of the sort of pharmacogenetic information 23andMe is now cleared to offer. However, it is also true that genetic testing companies have proliferated in recent years.

Widespread interest in genealogy has enabled Ancestry.com to become the biggest player in the field but it is trailed by a long tail of smaller firms that provide assorted health reports. Futura Genetics sells to consumers the ability to "discover and reduce your likelihood of developing 28 common conditions," while TeloYears markets "a different DNA test to help you stay younger longer." Many companies in the long tail have CLIA-certified laboratories but FDA clearance is far rarer.

The FDA is looking into certain developers that may be inappropriately selling genetic tests for the unapproved uses noted above, and will take compliance actions when appropriate. We will continue to monitor reports of adverse events associated with this issue and will keep the public informed if significant new information becomes available.