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23andMe Back in Genetic Testing Business

It is the only company providing genetic profiling information to consumers

Two years ago, 23andMe offered saliva kits for $99 that offered to analyze DNA and predict risks for health threats. Soon after, the company received a warning letter from the FDA for its health-analysis tests, and the company pulled its products from the market.  Now, the company is back, offering genetic testing through a method that doesn’t require FDA approval and at a heftier price tag of $199.

As reported by Time, your genetic information can now be categorized into four buckets: carrier status, wellness, traits, and ancestry. The carrier status tests are greenlit by the FDA; testing for them doesn’t require approval because they only detect whether a person harbors, or carries, the variant for a particular condition without actually having the disease.

That list now includes 36 conditions for which you can inherit versions of disease-linked genes from one parent or another but still be healthy. Only when two people who are carriers decide to have a baby is there a 25% risk of that baby developing the disease.

Some of those conditions are well-established gene-based disorders such as cystic fibrosis and sickle cell anemia, while most are more unfamiliar — like Nijmegen breakage syndrome and rhizomelic chondrodysplasia punctata type 1. All of them are conditions for which there is solid scientific evidence — at least three scientific papers published in the scientific literature, in fact — that the genetic variation is linked to the condition. That’s the minimum requirement from the FDA for supporting the validity of 23andMe’s test for genetic conditions.

The company’s disease-based genetic information, which was the hallmark of the company’s services, is now just one part of a broader set of profiles the company returns on what your DNA reveals about you. Also included is wellness-related information on four features: how likely you are to like caffeine, whether you’re lactose intolerant, if you tend to get red and flushed when you drink alcohol, and your what your muscle composition is like. These are features that can influence your behavior, says Brad Kittridge, vice president of product at the company, but aren’t necessarily considered diseases. “We wanted to make clearer a set of traits that are health-related, but not clinical, that have to do with behaviors but we wouldn’t call disease.”

Source: Time, October 21, 2015

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