The U.S. Food and Drug Administration has allowed Google-backed company 23andMe to begin marketing a home genetic test for Bloom Syndrome — an inherited condition characterized by shortness of height and increased risk of cancer.
The FDA also announced that it intends to exempt similar genetic testing devices from its premarket review protocol.
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Screening tests are largely used by prospective parents who are concerned that their future children may inherent harmful genetic disorders.
“Today’s authorization … along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers” stated spokesman Alberto Gutierrez.
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