Yesterday, 23andMe received FDA approval for Bloom Syndrome testing. Blood syndrome is a rare autosomal recessive disorder associated with a variety of serious illnesses including an increased risk for cancer. The FDA considers each genetic test individually, assessing both its validity and any potential harmful outcomes of knowing such results. Bloom syndrome testing is most relevant to potential parents as both individuals need to be carriers for their potential child to contract the disease - the FDA found no harm in potential parents knowing such information. This is an important step towards future approval of genetic testing and an exciting look at what the future of DTC genetic testing holds. It is likely that 23andMe will continue to petition the approval of more tests.
Links for News Articles:
Extreme Tech
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Related:
Original FDA
warning letter
Saira Agarwala
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