June 10, 2014

Assessing Direct-to-Consumer Genetic Testing

By AJ Montpetit

Recently published in the May issue of Clinical Chemistry, Linnea Baudhuin, Ph.D., of the Mayo Clinic Center for Individualized Medicine, assessed 23andMe, one of the largest direct-to-consumer genetic testing facilities, and its Personal Genome Service test.

One of her main critiques is that it is not a comprehensive genetic analysis, a limitation about which many consumers are not aware. Though many medical conditions might be associated with a long list of pathogenic mutations, sometimes numbering in the thousands, the Personal Genome Service test only detects a small percentage of these.

Dr. Baudhuin surmises that the FDA was left with no choice but to require that if 23andME wanted to sell a health-related medical device to consumers, it needed to demonstrate that the product is safe and effective, or cease offering the test.


Read the full article here.





Tags: 23andMe, center for individualized medicine, dna test, DNA Testing, gene sequencing, Genetics, genome, genome science, Genome Sequencing, genomic medicine, genomics, individualized medicine, mayo clinic, microbiome, personal genomics, personalized care, personalized medicine, predictive medicine, Uncategorized, whole genome sequencing

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