Patenting and Personal Genomics: 23andMe Receives its First Patent, and Plenty of Questions

Earlier this week 23andMe, the Silicon Valley-based personal genomics company, was awarded its first patent: US Patent Number 8,187,811, entitled “Polymorphisms associated with Parkinson’s disease”.

23andMe co-founder Anne Wojcicki announced the issuance of the patent via a post on the company’s blog late Monday evening, attempting to strike a tenuous balance between her company’s oft-championed philosophical devotion to providing individuals with “unfettered access to their genomes” and its desire to commercialize the genomic information so many of those very same individuals have shared, free of charge, with 23andMe. With its new patent, 23andMe also injected itself into the middle of what Wojcicki herself described as the “hot debate” surrounding the patentability of “inventions related to genetics.” Wojcicki’s announcement appeared to catch more than a few of the company’s customers by surprise, sparking concern about the company’s intentions on 23andMe’s blog, Twitter and elsewhere, along with rapid and pointed commentaries from Stuart Hogarth and Madeleine Ball, among others.

Of the various questions asked of and about 23andMe and its new patent, these may be the three most common: Where did this patent come from, and why didn’t I hear about it before? What does 23andMe’s patent cover? How is 23andMe going to use its patent? Let’s take each question in turn.

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Filed under Biobanking, Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomics & Society, Industry News, Informed Consent, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP

Co-Founder Linda Avey Leaves 23andMe to Start New Alzheimer’s Foundation

AlzheimersDTC genomics company 23andMe announced late Friday afternoon that co-founder Linda Avey was leaving the personal genomics start-up, effective immediately, to begin work on a new foundation focusing on Alzheimer’s disease. Kara Swisher at BoomTown has the full scoop, including copies of internal emails to 23andMe employees from both Linda Avey and the company’s other co-founder, Anne Wojcicki.

The announcement is certainly fertile ground for speculation. Avey’s own email begins by recognizing “that [23andMe] has reached a critical point in its growth where new leadership can take it to the successful heights we all think it can achieve.” Which at least prompts the question: Was there some element of the old leadership (i.e., Avey and Wojicki) that was deemed incapable of reaching those heights? There has been no public indication that the move is related to 23andMe’s current financing round, which has included investments from Sergey Brin, Google’s co-founder and Wojcicki’s husband, and from Google itself.

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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomics & Society

Genomic Research Goes DTC

The first generation of Direct-to-Consumer genetic testing and sequencing was populated by companies such as 23andMe, Navigenics and deCODEme that offered genotyping for a limited set of conditions, focusing primarily on genealogy and monogenic traits.

As the cost of generating genetic data continued to decline new companies brought new commercial offerings to the table, including whole-genome sequencing from Knome and, more recently, Illumina, and an increasing focus on the genetics underlying complex diseases and traits.

Recruiting Customers as Research Subjects

Even more recently a new dimension to the field of DTC genetics has emerged: Direct-to-Consumer research.  In May of 2008 23andMe’s founders laid out their vision for customer-driven research23andWe, as the company’s research arm is known, launched its first significant project in March of this year when, aided by financial support from Sergey Brin, the co-founder of Google and the husband of 23andMe co-founder Anne Wojcicki, 23andMe announced a large-scale study aimed at the genetic bases of Parkinson’s disease.  The study aims to recruit 10,000 patients with Parkinson’s disease to enroll.  Participants in the study will receive 23andMe’s services for $25, a steep discount from the going rate of $399.

researchAnd on Tuesday, 23andMe announced what it is terming the “Research Revolution, a community outreach program that empowers people to drive the direction of genetic research.”  In some ways this Research Revolution is genomic research meets American Idol, with the general public invited to vote by participating in the project and choosing from a list of 10 diseases to support.  (Participation costs $99 for a stripped-down version of 23andMe’s service that does not include several key features, including ancestry information, carrier testing and access to the underlying raw genetic data).

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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Sequencing, Genomics & Society, Informed Consent, Pending Litigation