Users of Consumer Genetic Testing Services Support Broader Access to These Services

By June 15, 2017
Sarah Gollust smiling

Associate Professor Sarah Gollust

Earlier this year, the U.S. Food and Drug Administration granted the direct-to-consumer genetic analysis service 23andMe approval to be the first company to market tests providing genetic risk information for 10 conditions, including Alzheimer’s and Parkinson’s disease. The change follows regulatory restrictions placed on the tests which have long been a point of health and consumer rights controversy among policymakers.

“Those who advocate for consumer access to genetic testing results argue that people have a right to their genetic information to make personal, lifestyle, or health-related decisions,” says School of Public Health Associate Professor Sarah Gollust. “Those who advocate against the practice say that for certain health conditions, the genetic information is inconclusive and confusing and can cause harms to consumers who may be upset or not understand their risk or what to do about it.”

According to Gollust, a key part of understanding the issue is discovering how consumers feel about the tests. To learn more, Gollust and a team of researchers from across the U.S. began a study prior to the FDA’s recent 23andMe announcement to measure consumer support for expanded access to testing. The study was published in the June 2017 edition of The Milbank Quarterly.

“Our findings show that consumers enthusiastically support access to genome testing,” says Gollust. ”This suggests that the recent FDA decision is in line with the sentiment of interested consumers.”

For the study, the research team analyzed survey responses and actual genetic testing data from 23andMe customers who had purchased services similar to the newly approved tests.

“We are able to see whether consumers who received genetic results indicating higher risk for disease had different attitudes than those who had lower risk for disease,” says Gollust. “We were surprised that this wasn’t the case. However, consumers’ subjective sense of their results did matter. For instance, those who reported being upset by their test results were less likely to endorse access to genetic testing services without a medical professional.”

Gollust said the results of the study suggest that access to personal genetic testing services will grow and that more analysis of their use is necessary to evaluate consumer safety.

“It will be important to continue to study and evaluate consumers of these services as the new FDA policy gets implemented to assess the harms and benefits to ensure that appropriate levels of regulatory oversight are in place,” says Gollust.

This study follows previous research by Gollust examining the marketing of direct-to-consumer genetic testing services.