Has the FDA’s ruling on direct-to-consumer genetic testing given power to the people?

April 18th, 2017

The US Food and Drug Administration announced on 6 April, 2017 that it has “allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional”.

“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease.”

While others will comment on the technical aspects of this ruling, we at Diaceutics see that from a strategic or market-shaping point of view this is really quite important. 23andme was set up to ‘consumerize’ access to genetic and familial history information whilst compiling a sizable database for disease research benefits. The company’s full model is already on display in Europe where tests can be ordered (conducted by a Dutch lab) and there is very user-friendly consumer access to the data.

The issue, of course, is that knowing your APOE4 status, for example, does not really fully define your predisposition to Alzheimer’s, and the major oncology biomarkers are not yet included. In the US, the FDA prohibited 23andMe from providing this information to consumers in case they ‘couldn’t handle the information’, so this partial restoration of the model may be a confidence-building step for the FDA.

23andme is actively collaborating on research projects – including work with Calico, Google’s research company that investigates ageing – so the value is more in the database. Nonetheless, it has been forecast that in the final analysis it is the patient or consumer who will drive precision testing and this is another step towards assimilating test data into the new concept of ‘wellness management’ rather than ‘sickness care’. By going down the consumer route companies like 23andme are potentially in a better position than pharma to monetize on this trend.

In addition, when the strategy is to have consumers pay for testing out of their own pockets and not necessarily via their insurers, companies can be laser-focused on getting the data directly from patients in the right format and be transparent about what they’re going to do with it. Obviously, whatever genetic information received has to be correlated with disease data but that’s why 23andMe collaborates with a group such as PatientsLikeMe, and they are likely to have plans to incorporate wearables and mobile technology into any research, too.

The fact is that testing is still not as routine as we might want, and payers are still putting up barriers that physicians and patients are required to jump. With this approval, 23andMe is paving the way for more people to get tested and giving possibly thousands of future patients the data they need and are happy to pay for themselves. As a result, payers may have to change their own approach. It’s clear, however, that a barrier to consumerization of diagnostic testing has now fallen which for us, and everyone putting patients at the centre of diagnostic commercialization, is a shift in the balance of power.


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