Tag: Bloom syndrome

A Note to Our Customers Regarding the FDA

By Anne Wojcicki Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US. This is also the first-time ...

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What The FDA Decision Means For 23andMe Customers

What does getting this marketing authorization mean for existing and future customers? As the first direct to consumer genetic test to complete the regulatory pathway, 23andMe’s Bloom Syndrome Carrier Status test was given marketing authorization through the de novo pathway. This is the first ...

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Before You Are Pregnant…

My sister learned she was a carrier for a recessive disease, Bloom syndrome, late in one of her pregnancies. I remember the panicked call and the weeks of worry as she and her husband awaited his test results; if he was also a carrier, this meant their daughter had a one in four chance of being born with the ...

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