The U.S. Food and Drug Administration (FDA) announced Wednesday that it has approved the marketing of 23andMe’s reports on pharmacogenetics, which the genetic-testing company claims are designed to assess whether genetics may affect an individual’s ability to metabolize certain drugs including antidepressants.
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23andMe customers might just play a role in helping create one of Big Pharma's next blockbuster drugs. This week, the genetic testing company announced it was entering a partnership with pharmaceutical giant GlaxoSmithKline (GSK) to develop new drugs and therapies. As part of the collaboration, the company will allow GSK to peek at the (voluntarily shared) genetic data of millions of people who have taken 23andMe's DNA home testing kits.
In a provocative opinion published Monday in STAT, 23andMe CEO Anne Wojcicki argues that home DNA test customers don't need experts to help them interpret genetic health risk reports. Wojcicki compares her company's health reports, which tell people whether they are at risk of developing certain diseases, to at-home pregnancy tests.
Not long ago, decrypting DNA was an expensive undertaking that could run into the hundreds of thousands of dollars. Now, for $200 you can spit into a test tube and find out about your ancestry, your risk of developing Alzheimer's, and even how likely you are to smell asparagus in your pee.
Earlier this month, when consumer genetic testing giant 23andMe announced plans to roll out the first consumer test for breast cancer risk, the news attracted some hefty criticism from the medical community. Sure, consumer DNA tests allow people to find out information about their health without a potentially pricey and inconvenient visit to the doctor. But without a doctor to help parse the results, some worry that at-home genetic tests may be misleading, inciting needless anxiety or a false sense of security.
If you've ever taken an ancestry DNA test, you probably already know that the results aren't exactly precise. Sometimes you wind up with completely different results than you expected. And different brands of DNA tests can beget entirely different results.
My grandfather was caramel-skinned with black eyes and thick, dark hair, and until he discovered that he was adopted, he had no reason to suspect that he was not the son of two poor Mexicans as he'd always been told. When he found his adoption papers, according to family lore, he pestered the nuns at the Dallas orphanage where he had lived as an infant for the name of his birth mother. Name in hand, at 10 years old, he hopped a bus to Pennsylvania, met his birth mother, and found out that he was actually Syrian.
The quest to figure out the right diet for maintaining an optimal weight is often less a quest and more a life-long battle. We cycle through fad diet after fad diet, hoping to eventually one day strike diet gold. Now, the consumer DNA testing company 23andMe is hoping to cut out some of the mystery of dieting, providing consumers with personalised weight loss advice as part of its genetic reports.
Since launching a decade ago, the consumer genetic testing company 23andMe has sold people more than two million DNA tests revealing information about their health and ancestry. Mail-in spit tests, though, aren't the company's long-term plan for striking it rich. On Tuesday, we got a peek at what is: Turning the genetic data from millions of customers into a massive drug-discovery pipeline.
At times, DNA testing can feel more like horoscopes than science. In many cases, we just don't know enough about a gene to say what it means for our health. For this reason, the US Food and Drug Administration has sought to protect consumers by preventing DNA testing companies from telling them whether or not they're are at risk for a certain disease. Until now.
Genetic testing company 23andMe is back in the business of direct-to-consumer health testing kits, after a two-year semi-hiatus (in the US, at least) from offering health risk assessments at the behest of the US Food and Drug Administration. That makes 23andMe the first such company to win FDA approval for taking its products straight to the consumer, with no need for a physician's approval.
23andMe quickly gained notoriety by providing private customers with health and ancestry information directly from their sequenced DNA, then, in 2013, it was stopped from providing health details by the FDA. Now it's got the green light to resume.
Five years after privacy advocates warned about the potential risks to privacy posed by massive genetics databases, they are, indeed, causing problems. Two popular geneology websites, Ancestry.com and 23andMe, both maintain such databases on behalf of private citizens. Now there's at least one case on record of Ancestry's data being used in a murder case, and 23andMe has seen a few requests too.
DNA testing startup 23andMe has been doing brisk business collecting genetic samples from over 800,000 customers. But the company just announced a new plan that will launch it into the big pharma world: 23andMe is going to invent its own pharmaceutical drugs using the data it collects from customer DNA.