Earlier this week on Wednesday the consumer genetics company 23andMe became the very first company to secure FDA approval for a report that has the ability to provide its customers with the information about how a person’s genetics may impact the efficacy of certain drugs. The initial approval which of course comes with certain regulations and guidelines for safety expands the company’s ability to offer medical information never available to its, customers-but some medical experts say people should approach the information with certain caution.
The approval for the reports has been the latest consumer advance in pharmacogenetics, the study of how a person’s genes may alter the effects of certain drugs, including blood thinners, anti-depressants, and even some opioids. In order to use this information saliva is provided as a sample by the users, 23andMe will then look for the 33 genetic variants that could influence the side effects of prescription drugs.
According to Kathy Hubbs, chief legal and regulatory officer at 23andMe, “Historically, there hasn’t necessarily been a convenient way to access that information, we want to make this proactively available to individuals, so it will ultimately become convenient when, and if, they ever do need any of these medications.”
The existing $199 Health and Ancestry service offered by 23andMe will include the report, but representatives released to TIME that it is not clear when it will be available to the public.
Recently, the company won FDA approval for tests for genetic variants associated with breast cancer, late-onset Alzheimer’s disease, Parkinson’s disease and more.
Many like Dr. Rebecca Sutphen, co-founder, and chief medical officer of InformedDNA, an organization dedicated to the appropriate use of genetic testing, believe that pharmacogenetics may not be ready for the spotlight. While research has shown the links between certain genetic variants and the metabolism of certain drugs, she says it’s not clear yet how those connections should influence prescriptions.
“People are just curious about their DNA, and reasonably so,” Sutphen says. “But unfortunately, for the case of pharmacogenetics, at this moment in time, it’s mostly potential power for the future, not for the present. There’s little that’s applicable to anyone’s current care.”
The approval of the reports also comes with important warnings which state people should not take the results of 23andMe’s report as medical advice and should consult a doctor before using the findings to justify taking — or ceasing to take — any medications.
“To even consider using any of the information in the test,” Sutphen says, “you would need a clinical test to be done.”
Hibbs explains the reports highlight the genetic variants that could affect someone’s reactions to certain classes of drugs rather than determining how one might respond to one specific drug.
The FDA announced, “health care providers should not use the test to make any treatment decisions.”
Sutphen says, “At this moment in time, there’s not an indication for most people to get genetic testing other than curiosity, where there are indications for people to get genetic testing, there are clear guidelines and targeted tests and genetic counseling to help interpret that information in the context of your personal needs and family history.”
The morning following the approval, the agency issued a warning to consumers, urging them to be cautious of similar tests on the market that may have not yet been approved by the FDA. Sutphen shares that while this genetic test can serve a purpose, all of them-even those with FDA approval-should be taken for fun rather than for medical advice. The reports are not yet available to the public but is said to make its debut within the next couple of months.
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