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Hannes Smarason: FDA Approval Advances DTC Genetic Testing


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23andMe is relaunching its direct-to-consumer genetic tests in the U.S. with the approval of the FDA to provide consumers “carrier status” information on 35 genes that can cause rare diseases. That the FDA has come so far so fast is indicative of the potential it likely sees in DTC genetic testing improving the health of U.S citizens. I am optimistic that DTC genetic testing will expand its impact over time, ultimately having a tremendous impact on human health globally.

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Hannes Smarason: FDA Approval Advances DTC Genetic Testing

  1. 1. FDA  Approval  Advances     Direct-­‐to-­‐Consumer  Gene7c  Tes7ng     Hannes  Smarason     Genome  Sequencing  |Personalized  Medicine  |  Transforming  Health  Care  
  2. 2. 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  
  3. 3. 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.    
  4. 4. 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.  
  5. 5. 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.  
  6. 6. 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      
  7. 7. 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