The Food and Drug Administration has approved a personal genomics test that people can use to find if they metabolize drugs quickly or slowly.
The agency said Wednesday that it had approved the 23andMe Personal Genome Service Pharmacogenetic Reports test. The test, which will be sold directly to consumers, is designed to provide information about genetic variants that may be associated with patients’ ability to metabolize some medications and thereby help inform discussions with their healthcare providers.
The FDA authorized the test to detect 33 variants for multiple genes. Pharmacogenetics is the process of understanding the role that genetics plays in a patient’s reaction to drugs, and the new test analyzes DNA from a self-collected sample of saliva. However, the FDA noted that the test is not designed to provide information on a patient’s ability to respond to a specific medication and does not describe an association between the detected genetic variants and any specific drug, nor whether the patient will respond to a drug. Rather, test results should be confirmed independently and should be used to make treatment decisions.
“The authorization allows 23andMe to provide customers with information on whether they are predicted to be fast or slow metabolizers based on their genetics, and when supported by appropriate clinical evidence, whether they may experience reduced efficacy or have an increased chance of side effects from certain medications,” a 23andMe spokesperson wrote in an email. “The informaiton the FDA authorized 23andMe to provide is not intended to help inform customers’ medical decisions.”
In May, Genomind and supermarket chain Albertson’s launched a pharmacogenetics pilot program at more than two dozen stores for patients on psychiatric drugs. Under the program, specially trained pharmacists can decide to counsel a patient if they see a pattern of unsuccessful treatment with medicines prescribed for depression, anxiety, obsessive-compulsive disorder or other mental conditions.
The approach has been touted in a number of medical specialties, including psychiatry. As many as half of patients with depression do not respond to their first antidepressant drug, and 30 percent of patients don’t respond to any drug, noted an article this month in the Journal of the American Medical Association. And while the antiepileptic drug carbamazepine is sometimes prescribed for bipolar disorder, in populations with a particular variant of the HLA-B gene – particularly those of Han Chinese descent – it can cause a life-threatening condition called Stevens-Johnson syndrome. However, experts quoted in JAMA said the marketing is head of the data and expressed caution about using commercially available test panels to guide mental healthcare decisions.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Photo: Natali_Mis, Getty Images
