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The U.S. Food and Drug Administration granted 23andMe authorization to offer ten genetic health risk reports including late-onset Alzheimer’s disease, Parkinson’s disease, celiac disease, and a condition associated with harmful blood clots.
For several years, 23andMe has worked on demonstrating that its reports are easy to understand and analytically valid in order to meet FDA requirements. The decision this week provides a clear pathway for submitting additional genetic health risk reports for the FDA’s consideration.
“The FDA has embraced innovation and has empowered people by authorizing direct access to this information,” said 23andMe co-founder and CEO Anne Wojcicki. “It is a significant step forward for 23andMe and for the adoption of personal genetics.”
It's been a twisted path. Here's some background on that:
Further Reading:
- FDA Orders 23andMe to Immediately Discontinue Marketing "Spit for Cancer" Kit
- FDA Says "Accurate" Genomic Tests Empower Consumers
- “FDA Opens Door For 23andMe To Market Some Direct-To-Consumer Genome Tests”; http://sco.lt/802Vtp
- 23andMe CEO Ann Wojcicki Learned Her Lesson; http://sco.lt/8uAMoj
Via Pharma Guy
