FDA Approval Advances Direct-‐to-‐Consumer Gene7c Tes7ng
Hannes Smarason Genome Sequencing |Personalized Medicine | Transforming Health Care
A Big, Posi7ve Step Forward
• Genomics industry maverick, 23andMe, has relaunched its direct-‐to-‐consumer (DTC) geneDc tesDng in the United States
• Landmark approval from the FDA allows 23andMe: – To report carrier status informaDon; and – To include informaDon on wellness, traits, and ancestry
• The newly launched 23andMe test now meets FDA standards and can inform consumers whether they carry a geneDc variant for one of 36 rare diseases that could potenDally be passed on to their children
Direct-‐to-‐Consumer Gene7c Tes7ng Implica7ons • For the genomics industry as a whole, this is a significant step forward. For
the first Dme ever, the FDA is allowing a company to provide a broad spectrum of medically relevant geneDc informaDon directly to consumers.
• Both the FDA and 23andMe deserve credit for working through challenges
that, less than two years ago, resulted in the FDA ordering 23andMe to stop markeDng its geneDc tesDng kits in the U.S.
• That the FDA—one of the world’s most thoughUul medical regulatory agencies—has come so far so fast is indicaDve of the potenDal DTC geneDc tesDng holds for improving the health of U.S ciDzens.
• And because the FDA’s decisions have global influence, that potenDal will spread worldwide.
The Journey Ahead for DTC Gene7c Tes7ng • Moving forward, there are at least two important direcDons that DTC geneDc tesDng will advance: – DTC geneDc tesDng will expand its reach globally; and – DTC geneDc tesDng will expand the medical impact of its reported results.
DTC gene7c tes7ng will expand its reach globally
• Over the decades to come, DTC geneDc tesDng services will: – Expand in response to consumer demand for improved health; – Require customizaDon by geography and culture; and
– Need approval from appropriate governmental agencies.
• While the genome is shared by all humans, DTC geneDc tesDng services will not be the same across all people living anywhere.
• Industry parDcipants must align their DTC reports and services to best
meet the needs of customers in specific countries and cultures—and do so in a spirit of cooperaDon with local health regulators.
DTC gene7c tes7ng will expand the medical impact of its reports
• The FDA’s approval for 23andMe’s carrier status report is a significant step forward, but more health data remains to be gleaned—and reported—from an individual’s genomic data
• Realizing the future potenDal for the right service to report directly to an individual consumer about risk for developing specific diseases will necessitate: – CooperaDon with regulators such as the FDA; and – CollaboraDon with physicians, researchers, geneDc counselors, etc.
• Informed, health-‐conscious consumers are very likely to demand access to this informaDon—and millions of individuals have already paid significant sums out-‐of-‐pocket to have their genomes sequenced and analyzed
An Exci7ng Future for DTC Gene7c Tes7ng • I am very opDmisDc that DTC geneDc tesDng will expand its impact over Dme – overcoming skepDcism and – having a tremendous impact on human health globally
• WuXi Ventures recently invested in 23andMe, making us acDve supporters of its current and noteworthy success – I am proud that our team at WuXi NextCODE will be a part of making this exciDng future happen