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23andMe’s Return Signals Expected Growth in DTC Market

by | Nov 17, 2015 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, DTC-dtet

In what is being hailed as "a milestone for consumer genetics," personal genomics company 23andMe (Mountain View, Calif.) received U.S. Food and Drug Administration (FDA) approval to launch a revamped direct- to-consumer genetic test that includes reports on 60 carrier status, wellness, trait, and ancestry findings. The late October launch of its overhauled test comes nearly two years after the FDA ordered the company to stop providing its health risk assessment test and just a week after the company raised $115 million in new funding. The revamped test costs $199 for 35 carrier status reports for autosomal recessive conditions including cystic fibrosis, sickle cell anemia, and hereditary hearing loss; four wellness reports including assessments related to caffeine consumption, lactose intolerance, alcohol flush reaction, and muscle composition; and more than 19 trait reports on hair, facial features, and taste and smell preferences. Notably, the new product lacks disease risk testing and pharmacogenomic evaluation. "They are still a long way away from getting back to where they were, returning results about people’s relative lifetime risks of developing various deleterious health conditions," Michelle Meyer, a bioethicist and legal scholar at the Icahn School of Medicine at Mount Sinai in New York, told Nature, […]

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