On October 31, 2018, the FDA announced that it had approved the marketing of yet another over-the-counter genetic test developed by 23andMe Inc. The new test, "Personal Genome Service Pharmacogenetic Report" provides information on eight drug metabolizing genes, and will help a patient know how quickly or slowly their body is likely to metabolize drugs associated with a particular gene. The results report won't provide specific drug names, since the intent of the test is not to cause a patient to switch treatments. The FDA recommends that patients take an additional test with an "independent" pharmacogenetics testing service before making such a decision.
Perhaps due to the FDA's concerns about the possibility of the public misconstruing the purpose of the test, on Thursday it issued a warning against the "use of many genetic tests with unapproved claims to predict patient response to specific medications."
While this is the first FDA test of its kind to be approved for direct-to-consumer marketing, similar kinds of pharmacokinetic lab tests have been available for years when obtained at the request of a health care provider. Genesight,
for example, states on its web site that the FDA has not decided to oversee its
tests, but meets or exceeds all industry quality standards and complies with
federal law and has been approved by CLIA (Clinical Laboratory Improvement
Amendments) and CAP (College of American Pathologists). Also, Medicare and the
Department of Veterans Affairs offer some coverage of the tests and even some private insurance will cover them.
Genesight result reports are sent to the physician but are fairly easy for the layman to understand, with drug names listed in categories, along with "red", "yellow", and "green" zones to indicate how well suited, based on the genetic assessment, the patient is for different categories of psychiatric drugs, pain drugs, or ADHD drugs. Because the report is drug specific, and provides information that goes beyond what might be related to drug metabolism markers in the genes, the FDA
has looked more closely at regulating the report claims of genetic testing labs like Genesight that it previously chose not to regulate.
At least seven FOIA requests at the FDA involve Genesight. Also
Myriad (Genesight's parent company) has faced litigation
over misleading genetic test statements.
Sources and more reading:
- INOVA Genomics Laboratory received warning letter from the
FDA for "illegally marketing certain genetic tests that have not
been reviewed by the FDA for safety and effectiveness."
https://www.askapatient.com/news/fda-drug-prices-blackbox-inova-warning.asp
- Clinical trial for veterans being treated for behavioral health conditions evaluting the Genesight test.
- Genesight: Medicare and other
Insurance Coverage/a>
of the tests
- Sample pharmacogentic report
(on page 4) for Psychotropic drugs/antidepressants by
Genesight. Includes antidepressants, antianxiety drugs,
antipsychotics, and mood stablizers.
- NBC News Report: "New Psychiatric DNA Testing is Unproven Ground" October 4, 2015
- FDA Safety Communication: warning to consumers about genetic tests that claim to predict patients' responses to specific medications.
November 1, 2018
- FDA News Release: FDA authorizes first direct-to-consumer test (by 23andMe) for detecting genetic variants that may be associated with medication metabolism. October 31, 2018
"This report describes if a person has variants associated with
metabolism of some therapeutics, but does not describe if a person
will or will not respond to a particular therapeutic, and does not
describe the association between detected variants and any specific
therapeutic. "
-FDA list of direct-to-consumer genetic tests:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests#list
Note that NONE fo the approved tests are meant to help recommend
a particular drug for a patient.
- Check out some patient reviews where patients used Genesight or
genetic testing to help choose an antidepressant:
Viibryd:
prescribed because of genetic testing
Viibryd:
genetic test pointed to Viibryd