Scheller, former executive VP of research and early development at Genentech, will be 23andMe’s Chief Scientific Officer and Head of Therapeutics.
“With Dr Scheller joining the team, we are putting significant resources into translating genetic information into the discovery and development of new therapies for our customers and the world,” said CEO Anne Wojcicki.
Scheller will lead an R&D team using human genetic data to uncover the biological mechanisms of common and rare diseases to identify new therapies. This therapeutics group will be connected to 23andMe’s research database.
“I believe that human genetics has a very important role to play in finding new treatments for disease. I am excited about the potential for what may be possible through 23andMe’s database. It is unlike any other,” said Scheller.
Scheller has a prestigious background outside his Genentech career. In 2013 he received the Albert Lasker Basic Medical Research Award for discoveries around the molecular mechanism underlying the rapid release of neurotransmitters.
First straight-to-consumer gene test
The FDA last month granted the company the first ever authorisation to market a genetic test directly to consumers. The service allows individuals to check if they are carriers for Bloom Syndrome.
The FDA gave permission for 23andMe’s test under its “de novo” regulatory pathway. This option provides an alternative to 510(k)s for evaluation of new devices of low-to-moderate risk which do not have a rival already on the market.
At the same time, the agency downgraded all other autosomal recessive disorder tests to Class II, meaning they will be exempt from FDA pre-market review.
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information.”
Easing the regulatory burden supports innovation and consumers, added Alberto Gutierrez, Director of FDA’s Office of In Vitro Diagnostics and Radiological Health.
23andMe will need to deliver additional reports to the regulator before it can offer its Bloom Syndrome Carrier test to individuals.
The company was founded in 2006 in Mountain View, California and received a $3.9m (€3.7m) investment from Google within a year.