A Fundamental Right to Genetic Information (Now More Expensive Than Before)

Fundamental RightsThis is the second of four related posts analyzing 23andMe’s decision to separate its health and ancestry DTC genetic testing services. For more please see 23andMe’s New Game Plan: What it Means for the Company and for DTC Genetic Testing, The Open Secret of DTC Medical Genetic Testing and DTC Genomic Research: Revolution or Minor Uprising?

An Unexpected Increase in Price. In considering 23andMe’s new model from the consumer perspective, the most surprising development is that the announcement comes with a price increase. With the steady drumbeat of stories heralding the approach of the $1,000 genome, and the consumer expectation that prices for established technologies are meant to fall, not rise, the price hike was unexpected.

23andMe is touting a few new features, mainly its recently announced Relative Finder tool and 13 new carrier status reports, including an expanded cystic fibrosis panel, as justification for the price increase. But the price hike combined with recent layoffs at the company is also fueling speculation that 23andMe is struggling to define a commercially viable product.

What’s more, the increase in price may cause some potential 23andMe customers to take a second look at some of its competitors. In July, Pathway Genomics launched its own DTC service with a split service model nearly identical to 23andMe’s new approach: ancestral testing for $199, health and disease testing for $249 and both the health and ancestry service for $349. What was a $50 discount on 23andMe’s service in July is a $150 discount today (assuming Pathway doesn’t follow suit with a price increase of its own), which may be enough to tip the scales for certain consumers.

At least this time around, none of 23andMe’s existing customers will be wondering about a refund.

A Fundamental Right (That You Pay For). 23andMe’s current $399 offering provides customers the ability to view and to download their raw genetic information. Although 23andMe provides an impressive array of interpretive tools and reports to help understand the raw data, making the raw data available for download has permitted individuals to publish that data online for others to review and to compare and contrast it with data provided by other DTC genetic testing companies.

Starting this week, however, neither of 23andMe’s stand-alone offerings – the $399 Ancestry Edition or the $429 Health Edition – will offer complete raw data access (although the Ancestry Edition does offer Y and Mitochondrial raw data). That access will now be reserved for customers purchasing the $499 Complete Edition.

For a commercial service provider such as 23andMe, there’s nothing inherently wrong – or even unusual – in choosing to make certain features available only to customers willing to pay a premium. In the case of 23andMe, however, the decision is at least a mild surprise. As Daniel MacArthur points out:

. . . until now 23andMe has been steadfast in its insistence that personal genomics customers should see everything that their genome yields, not just fragments of it – the consistent subtext being that the whole raison d’etre of personal genomics should be the pursuit of broad intellectual curiosity and self-exploration rather than a desire to look purely for information relevant to health or some other specific interest. That ideal now appears to yielding to market forces.

The apparent shift in philosophy is all the more noteworthy given the back-and-forth exchange earlier this month between 23andMe and Kaiser Permanente in which 23andMe co-founder Anne Wojcicki criticized Kaiser for its decision not to return genetic information to its research participants. In criticizing Kaiser and arguing that “Research participants have a right to their own genetic data,” Wojckicki said this about her own company: “I co-founded 23andMe, a personal genetics company, to enable individuals to access their genetic information—what we believe to be a fundamental right.”

That “fundamental right” is one that 23andMe customers have always had to pay for but, at present, it is one that every new 23andMe customer receives. On Thursday, that will change, with the “fundamental right” being reserved for the highest-paying customers.

If 23andMe was a pure service provider it would be easy to distinguish its decision to require its customers to pay for access to their genetic information while criticizing the Kaiser study for failing to return very similar information to research participants. But 23andMe does more with its customers’ raw genetic information than simply interpreting and returning it to the individual customer. The company’s novel approach to genetic research has been well documented here at the GLR, and 23andMe’s current Terms of Service remind customers that “by your participation in the 23andMe service you contribute your genetic information to our research effort to study various aspects of human genetics in an attempt to better understand the human genome.”

23andMe has not said whether it will continue to use genetic information supplied by customers purchasing at the $399 or $429 levels in its ongoing research efforts, despite not making the raw genetic data available to those customers. If it does, it will be interesting to see whether and how 23andMe attempts to justify its decision to withhold from certain of its own research participants (who are also paying customers) the “fundamental right” to their genetic information, particularly so soon after critiquing Kaiser for a substantially similar practice.

Holding Out For More Money. Also unknown is how 23andMe will handle the return of medically useful genetic information to individuals who purchase only the company’s “Ancestry Edition” product.

In Wojcicki’s Kaiser commentary she noted that genetic data, such as the kind commonly returned by23andMe, “. . . might reveal that an individual is at higher risk for certain diseases such as age-related macular degeneration, blood clots, Parkinson’s disease or breast cancer,” along with carrier and pharmacogenetics status information. Beginning Thursday, that’s the type of information that will show up in both the Health Edition and the Complete Edition, but not in the Ancestry Edition.

In its announcement, 23andMe clarifies that customers aren’t bound by their initial purchase: “You can always buy one version, either the Health or Ancestry Edition, and upgrade to the Complete Edition at a later date. You won’t even need to spit again!” No additional spitting is necessary because, unless 23andMe is planning to take another page from the Pathway playbook and introduce separate health and ancestry chips, 23andMe’s current v2 chip contains both types of genetic information on a single customized chip, meaning the data crunching is all done at once. After that, 23andMe has access to the “Complete Edition” for each individual, even if it only chooses to release the “Health Edition” or “Ancestry Edition” data for particular customers.

23andMe is clearly hoping that, sooner or later, its customers will want to access all of their data, and that they’ll be willing to pay a bit extra to do so. But at least for some individuals who purchase the Ancestry Edition and choose not to upgrade, 23andMe is likely to be sitting on genetic information of identifiable medical utility. Which will place 23andMe in the uncomfortable (but commercially understandable) position of withholding medically useful information in an attempt to extract a higher fee.

To the best of my knowledge, this represents a new dynamic in the world of DTC genetic testing, and it extends to the realm of DTC genetic testing a number of questions that have long troubled physicians, researchers and courts, such as whether and when doctors, researchers and companies have a duty to return information, including genetic information, that is of medical importance to an individual. That’s a topic that the GLR will be investigating in more detail in the coming weeks.

Filed under: Biobanking, Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Industry News
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