The NHS is having to'pick up the pieces' of growing use of cheap genetic tests, doctors warned last night. Popular DNA tests such as those made by '23andMe' - which are widely available in pharmacists and online - can easily be misinterpreted, experts said. A panel of experts from Southampton University, Exeter University and Southampton Hospital said'direct-to-consumer' genetic tests are unreliable and leave people confused and uncertain. Writing in the British Medical Journal, they said genetic information is complex and even if people are shown to be at risk they need carefully walking through the results by a doctor – not left to panic at home. The writers, who include Professor Anneke Lucassen, president of the British Society for Genetic Medicine, said these tests should'absolutely not be used to inform health decisions without further scrutiny'.
The FDA has given genetic testing giant 23andMe the go-ahead to sell a screening kit to tell consumers how well certain drugs will work them. At the same time, the agency with a stark warning that most genetic tests can't be trusted to fulfill that need. Direct-to-consumer genetic testing is a hot and controversial topic among doctors, patients and regulators alike. While proponents say tests like 23andMe give consumers a better understanding of and agency over their own health (at a relatively low price point), skeptics argue that direct-to-consumer medical tests don't paint a complete picture. And doctors - let alone patients - rarely have the right training to interpret the complex risk factors signaled by genetic variants, experts caution.
A logo sign marks the headquarters of 23andMe in Mountain View, Calif., on Jan. 24, 2016. A logo sign marks the headquarters of 23andMe in Mountain View, Calif., on Jan. 24, 2016. Genetic testing firm 23andMe got approval from the Food and Drug Administration last week to sell reports that show customers whether they have an increased genetic risk of developing certain diseases and conditions. The go-ahead is the first time the federal agency has approved such direct-to-consumer genetic tests and comes about three years after the FDA warned Mountain View, Calif.-based 23andMe to stop marketing its health reports because they lacked agency authorization. The company removed health-related results from its genetic tests after this warning, providing only ancestry information and raw genetic data without interpretation.
Direct-to-consumer (DTC) testing is exactly what the name implies: a test sold directly to the consumer, without the help of a health care professional. You can pick up a kit on-line, at the drug store, or even at the dollar store (!) that you can use to determine if you are pregnant or have a sexually transmitted disease. You, the consumer, are responsible for collecting the sample and for interpreting the test result, without the help (or hindrance?) of the health care system. So how accurate are DTC genetic tests? The truth is that testing runs the gamut of quality, ranging from medical-grade accuracy to total garbage.
Popular direct-to-consumer DNA kits that promise to reveal a person's heritage and details about their health provide false information to two in five users, a new study published in the journal Genetics in Medicine suggests. The troubling data comes from research conducted by medical diagnostics company Ambry Genetics. The researchers found that consumer DNA tests can often fall victim to false-positives that result in producing incorrect information. Consumer DNA tests like 23andMe, pictured, produce false-positives for two-in-five people. Consumer DNA tests often do not look at the entirety of an individual's genome.