FDA NewsPerspective

FDA allows for expanded marketing of 23andMe to include medication metabolism

The FDA expanded the approved marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports test to include information about 33 genetic variants that may be linked with a patient’s ability to metabolize some medications to help inform discussions with a health care provider, according to an agency press release.

“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. We know that consumers are increasingly interested in genetic information to help make decisions about their health care,” Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release.

The FDA said it granted the expansion based on data that the 23andMe’s manufacturer provided to show that the test is accurate and provides reproducible results.

This announcement is the latest within the past several past years that expands the use of the 23andMe test and genetic information in health care.

In 2014, 23andMe and Pfizer teamed up to study potential genetic factors associated with Crohn’s disease and ulcerative colitis. A year later, 23andMe began enrollment into a genomic study of patients with systemic lupus erythematosus in collaboration with Pfizer and the Lupus Research Institute.

In 2017, the FDA authorized marketing of 23andMe for 10 diseases and conditions, including Alzheimer’s disease, Parkinson’s disease and celiac disease. Then in March of this year, the FDA authorized more marketing for the 23andMe test, this time for three mutations of BRCA1 and BRCA2 most common among people of Eastern European Ashkenazi Jewish descent.

Increasingly, use of genetic information as a means to estimate disease risk is finding its way into health care. In July, Geisinger Health System began giving its patients the option of having their blood drawn to see if they have any gene variations that cause heart disease and early-stage cancers, but not diseases considered nonactionable. Healio has also previously reported on ways that could potential make the most of direct-to-consumer genetic testing, including discussing goals and limitations with patients seeking to use these tests.

Despite the stream of new uses for genetic information, other FDA officials cautioned that not all genetic tests are alike and urged everyone to investigate any such tests’ claims cautiously.

Pill Bottles 
The FDA expanded the marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports test to provide information about 33 genetic variants that may be linked with a patient’s ability to metabolize some medications to help inform discussions with a health care provider, according to an agency press release.
Source: Shutterstock

“We are warning consumers about many such genetic tests being marketed directly to consumers or offered through health care providers that claim to predict how a patient will respond to specific medications. 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,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said in a separate press release.

“We note our concern about health care providers and patients inappropriately selecting or changing drug treatment based on the results from insufficiently substantiated genetic tests, which could lead to potentially serious health consequences for patients. For example, a patient may change the dose of their medication for a particular condition or disease based on the results of an unproven genetic test, which may result in inadequate care or worsening illness,” they added.- by Janel Miller

Disclosures: Stenzel, Shuren and Woodcock all work for the FDA.

The FDA expanded the approved marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports test to include information about 33 genetic variants that may be linked with a patient’s ability to metabolize some medications to help inform discussions with a health care provider, according to an agency press release.

“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. We know that consumers are increasingly interested in genetic information to help make decisions about their health care,” Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release.

The FDA said it granted the expansion based on data that the 23andMe’s manufacturer provided to show that the test is accurate and provides reproducible results.

This announcement is the latest within the past several past years that expands the use of the 23andMe test and genetic information in health care.

In 2014, 23andMe and Pfizer teamed up to study potential genetic factors associated with Crohn’s disease and ulcerative colitis. A year later, 23andMe began enrollment into a genomic study of patients with systemic lupus erythematosus in collaboration with Pfizer and the Lupus Research Institute.

In 2017, the FDA authorized marketing of 23andMe for 10 diseases and conditions, including Alzheimer’s disease, Parkinson’s disease and celiac disease. Then in March of this year, the FDA authorized more marketing for the 23andMe test, this time for three mutations of BRCA1 and BRCA2 most common among people of Eastern European Ashkenazi Jewish descent.

Increasingly, use of genetic information as a means to estimate disease risk is finding its way into health care. In July, Geisinger Health System began giving its patients the option of having their blood drawn to see if they have any gene variations that cause heart disease and early-stage cancers, but not diseases considered nonactionable. Healio has also previously reported on ways that could potential make the most of direct-to-consumer genetic testing, including discussing goals and limitations with patients seeking to use these tests.

Despite the stream of new uses for genetic information, other FDA officials cautioned that not all genetic tests are alike and urged everyone to investigate any such tests’ claims cautiously.

Pill Bottles 
The FDA expanded the marketing of the 23andMe Personal Genome Service Pharmacogenetic Reports test to provide information about 33 genetic variants that may be linked with a patient’s ability to metabolize some medications to help inform discussions with a health care provider, according to an agency press release.
Source: Shutterstock

“We are warning consumers about many such genetic tests being marketed directly to consumers or offered through health care providers that claim to predict how a patient will respond to specific medications. 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,” Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research said in a separate press release.

“We note our concern about health care providers and patients inappropriately selecting or changing drug treatment based on the results from insufficiently substantiated genetic tests, which could lead to potentially serious health consequences for patients. For example, a patient may change the dose of their medication for a particular condition or disease based on the results of an unproven genetic test, which may result in inadequate care or worsening illness,” they added.- by Janel Miller

Disclosures: Stenzel, Shuren and Woodcock all work for the FDA.

    Perspective
    Robert Segal

    Robert Segal

    We have known for some time that certain patients respond differently to similar medications. Some patients are fast metabolizers, meaning they clear and deactivate some medications quickly and some are slow metabolizers. Many people have also seen this in life with alcohol as many Asians have what is called “Asian Flush” and they cannot clear the alcohol as efficiently as other people.

    The potential here with the FDA’s recent decision to expand marketing of 23andMe to include medication metabolism is that doctors can now screen for certain genetic predispositions that will help physicians choose the best and most effective medication. For example, some patients deactivate and metabolize Plavix (clopidogrel, Sanofi-Aventis) too quickly for this particular medication to be effective. If the physician has the power to screen for the genetic variant that speeds up the metabolism the physician will be able to avoid using clopidogrel on those patients and choose another more effective medication.

    Medical practitioners should be prepared for several questions from patients in light of the FDA’s recent decision.

    One: Should I undergo genetic screening? The answer to this depends on the treatment and medication involved. For life or death questions, like the best treatment post cardiac arrest, then it would be wise to make sure you are getting the most effective treatment. If, however, the question is about which antibiotic will be most effective, since we are talking about 80% effectiveness vs. 75% effectiveness, the genetic screen may not be worth the cost and effort at this time.

    Two: How accurate is the test? I would tell patients who ask that this test only gives limited data. As Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, put it, “The test is not intended to provide information on a patient’s ability to respond to any specific medication. The test 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. Furthermore, 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.”

    However, if 23andMe or another genetic test pans out and is validated, it will bring in a new age of precision personalized medicine paring the best treatment option for the patient.

    • Robert Segal, MD
    • Medical Offices of Manhattan
      co-founder, Labfinder.com

    Disclosures: Segal does not report any relevant financial disclosures.