After being warned by the U.S. Food & Drug Administration (FDA) in 2013 to immediately discontinue their services, 23andMe is back in business. Curious consumers can once again ship off a saliva sample to the Google-backed company to learn about the secrets encoded in their genes.
But what can you really learn about yourself from these tests? And do you even want to know?
For $199, 23andMes new Personal Genome Service (PGS) will tell you whether you carry any of one of 36 mutations that can put you at risk of having a child with a genetic disorder, including cystic fibrosis and beta thalassemia, a blood disorder that causes anemia, stunted growth and other problems. They can also test your carrier status for more even more rare conditions like Bloom syndrome, which causes sensitivity to the sun and an increased risk for cancer.
The company will also continue to offer the wellness component of their report, which mostly tests for things you already know: how you might react to caffeine, for example, and how likely you are to be energy providers lactose intolerant. Of those tests, 23andMe president Andy Page explained to Business Insider: It isnt always about the test outcome. Just engaging in the genetics and learning fun things it tells people dont be afraid.’
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What the new version doesnt wade into are the murky waters of whether you carry genes that boost your likelihood of cancer or affect how you respond to certain drugs. Thats what got 23andMe in trouble with its first Personal Genome Service, which claimed to offer users health reports on 254 diseases and conditions, including breast cancer and Alzheimers disease.
Back in November 2013, the FDA sternly warned 23andMe to stop selling this test to consumers, saying that the company was violating federal law by selling a device without marketing clearance or approval, and putting people at risk by giving them potentially inaccurate information on life-or-death health issues.
23andMe and its competitors were offering health information based on sound bites of DNA known as single-nucleotide polymorphisms, or home improvement SNPs, with results that were wide open to interpretation, explained Joy Larsen Haidle, a genetic counselor at the Humphrey Cancer Center in Minneapolis and current president of the National Society of Genetic Counselors.
It was difficult for consumers to be able to determine how accurate the test result is, how reliable it is, and if you sent a test result to more than one lab you could easily get a different interpretation of creative outdoor designs your risk based on the same question, Larsen Haidle said. That was part of what prompted the whole concern in that era.
23andMe quickly stopped selling its $99 spit kit after the FDA smackdown. The new version, according to a 23andMe press release, is the product of two years of work with the heating FDA, extensive user comprehension testing and a complete redesign.
Its a test that is most useful for those who are pregnant or considering planning for a pregnancy and are interested in knowing their risk to have a child with one of these genetic disorders that are tested for in their panel, said Dr. Jerry Feldman, PhD, president of the American College of Medical Genetics and Genomics. This is the type of testing thats routinely been offered to pregnant women or couples interested in knowing this information for many years, and there are some guidelines by the various physician organizations that make specific recommendations in regards to such testing.
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He added: What theyre offering from a testing standpoint is not unique, other than that it is an FDA-approved test and it offers patients the opportunity to have that testing performed direct-to-consumer.
What concerns Feldman about direct-to-consumer testing is the need to make sure that patients understand what the test involves and what it will tell them, and how to interpret the results. Our recommendation is to always have a genetics health care professional, such as a board-certified clinical geneticist or genetic counselor, involved in that process, he says. And, he explains, patients need to know that theres a risk to getting this kind of information without having all the appropriate genetic counseling that goes along with it.
There is definitely a place for direct-to-consumer genetic testing, Larsen Haidle said, with some caveats. Whats important for consumers is that details for your garden if they choose to have a direct test done, if they had a result that they werent certain what it meant or how to use it, meeting with a genetic counselor can be a good next step, she says. Were happy to see them and be a resource.
She added: Were always in such a hurry that it is really worthwhile to take a moment and think about the root issue, what is it that Im looking forand will the test result help me reach that goal?
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Consumers also need to be sure to provide informed consent before sending in a sample for testing, she added, and to be fully aware of how their genetic information might be used.
Feldman and Larsen Haidle agree were still a long way away from the sci-fi promise of being able to read our medical fate in our genes.
Genetic testing is evolving and evolving rapidly because new technology is making it more feasible to obtain that type of genetic information. However, there is certainly a lot more research and understanding of that genetic information that has to take place before it would become routine for every individual to have that testing performed and be given information that would be medically useful in all circumstances, Feldman said.
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An easy first step anyone can take toward the future of personalized medicine, according to Larsen Haidle, is to get to know your family medical history, and talk with relatives about the kinds of health problems that run in the family, and when people were diagnosed.
Any test that we have, the interpretation of it is best done in the context of your personal and family medical history, she said.
This article originally appeared on Health.com.