The FDA has ruled that the home 23andme genetic test is not safe because it has not been approved by general safety standards and it could lead to potential dangerous health conditions if the test does not work appropriately. In this day and age many people are turning to home tests instead of going to their doctors. This practice can be tricky, if not dangerous in many instances. This 23andme home genome test is supposed to test for disease risks and potential health risks by analyzing human saliva.
Since 2009 the FDA has been trying to work with the company in order to reach safety compliance rules and 23andme has produced a variety of communications in order to obtain the go ahead from the FDA. The FDA is still very concerned about assurance issues with the company though because clinical and analytic testing has still yet to be truly validated in order to prove its effectiveness in being able to even detect these disorders with a high ratio of success.
Warnings from the FDA come from the fact that this 23andme home testing product can put patient lives in danger due to the high ratio of false positives and false negatives for any high risk health indications. If the test shows a false positive result on something like ovarian or breast cancer, a patients health is at stake if they end up going into a variety of chemo treatments and surgeries, while a false negative would result in a patient not receiving the correct, early treatment needed for such life threatening conditions. All though, no matter what a test result shows, it is always wise for a person to get the results reconfirmed by their doctor to determine what is the best route of treatments if needed.
23andme was founded in 2006, but still refuses to comment on what would happen to the company if they continue to fail FDA standards. Many home DNA tests have been widely criticized because only a fraction of a patients genetic makeup can really be examined by such tests. In 2010 investigators from the US Accountability Office finalized that 23andme and Navigenics of Foster City were actually offering false information and little to no actual health information use. Both companies support their products, even though they give out misleading information on patients medical conditions. Almost half a million people have purchased the 23andme genome test. Patients are told to submit and mail in saliva to be tested and then health recommendations will be mailed back, such as telling customers to watch their gluten intake because their DNA showed a high probability of Celiac Disease. And Celiac Disease is only confirmed medically by taking a small intestinal tissue sample and blood tests in order to be rightfully confirmed. There is no such thing as taking a saliva test to confirm this disorder.
In 2008 investigations were brought about in California due to concerns, and they found that some of these companies do not have proper state licenses. Life Technologies of Carlsbad bought Navigenics, and they have no problems what so ever with the FDA, although their products are primarily used for research purposes.
Within the same year, The American Journal of Human Genetics confirmed that such tests really do not do any good without proper scientific evidence to prove that they are even useful in finding basic genetic disorders. And the US Department of Health and Human Services also concluded that there are major gaps in the US system in watching for potential harms from these particular products.
So the wait continues until the FDA gets tired of dealing with the 23andme company. The company continues to claim that they are in the process of getting scientific proof together to submit, but the FDA said there is no proof that such promises are actually being conducted. So for now, 23andme home genome testing will continue on it’s course with the FDA’s disapproval, unless they can actually save face and do what they say.
By Tina Elliott
San Jose Mercury news
The Wall Street Journal
The Washington Post