- Special Sections
- Public Notices
Recently, there have been lots of advertisements by a genetics company for testing of your various genes. The company is 23andMe. This company measures hundreds of your genes from your saliva.
They clearly mention that this test does not replace your physician. The implication of the tests is that it guides you in various aspects of your life. Certain genetic changes may make you more susceptible to certain drugs and others may make you more likely to get certain cancers or other health conditions. Some of these you may be able to prevent and others you may not.
This all sounds well and good and helpful. It costs only $99 and so it is not very expensive. What is the caveat?
Recently, the FDA has asked the company to stop marketing its product.
The Mountain View, Calif., company’s saliva collection kit and Personal Genome Service (PGS) is being marketed “without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act),” the agency said in a letter to the company posted on the FDA website Monday. “Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”
In its letter, the FDA says: “Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.”
Is this real or just the FDA stepping its boundary or is it government over regulating the public? I don’t think so. Reliability of any test depends on the accuracy. Inaccurate tests may do more harm than good. As per the FDA, “The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.”
I am not saying that “23 and Me” testing is of poor quality, but I definitely agree that proper oversight is extremely important. In short, think twice before going for unapproved testing.
Dr. Sunil Gandhi is a hematologist and oncologist. He is the volunteer medical adviser of the Citrus Unit of American Cancer Society. Write to 521 N. Lecanto Highway, Lecanto, FL 34461, email email@example.com or call 352-746-0707.