On February 19, the
"Food and Drug Administration" (FDA) granted 23andMe a marketing authorization (MA) opening a new chapter in the regulation of screening methods made possible by advances exponentially around the genetic sequencing [1]. The test in question allows the detection port of the recessive allele of a gene responsible Bloom's syndrome, a rare genetic disease causing stunted growth and increased risk of developing cancer. It is particularly suitable for future parents, if both would be from Central or Eastern Europe, especially among Ashkenazi Jewish families.
This is the first genetic test directly for the general public, without the need to go through a health professional. 23andMe and all the industry players can look forward to such a decision, reflecting the willingness of the US authorities to facilitate the emergence of such tests and accompany the genomic revolution in the industry.
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