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Rather, the breast cancer mutation screen was classified as a type of medical device with obligations for the company to reduce risks to customers.

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The agency gave personal genomics company 23andMe the green light to screen samples for breast cancer–related genetic mutations.

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image: The Rising Research Profile of 23andMe

The Rising Research Profile of 23andMe

By Catherine Offord | December 1, 2017

An exploration of the genetics of earlobe attachment is just the latest collaborative research project to come out of the personal genetic testing company.

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23andMe customers can now receive information about genetic risk for diseases including Parkinson’s and celiac.

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Access to data from thousands of genotyping customers helped scientists detect novel associations with the disorder across the genome.

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image: 23andMe Markets Genome Kits to Researchers

23andMe Markets Genome Kits to Researchers

By Kerry Grens | July 14, 2016

Scientists can now buy the direct-to-consumer sequencing product, and research participants can join 23andMe’s database.

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image: Genetic Connections Among Human Traits

Genetic Connections Among Human Traits

By Anna Azvolinsky | May 16, 2016

A study identifies genetic variants that are linked to multiple phenotypes.

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image: Genetic Resilience

Genetic Resilience

By Tanya Lewis | April 11, 2016

An analysis of the genomes of nearly 600,000 healthy individuals reveals a handful of people who appear resistant to certain genetic disorders.

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image: GWAS IDs “Morning People”

GWAS IDs “Morning People”

By Catherine Offord | February 4, 2016

In a large genome-wide association study, researchers from 23andMe locate 15 DNA regions associated with people’s preferences for early morning starts.

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image: Following FDA OK, 23andMe to Expand Health Prediction

Following FDA OK, 23andMe to Expand Health Prediction

By Kerry Grens | October 21, 2015

The personal genomics firm is ramping up its suite of disease-related genetic tests.

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