No FDA Oversight of Some Genetic Testing Companies

Not all direct-to-consumer genetic testing companies are subject to the same federal oversight.

Some, like 23andMe, are regulated by the U.S. Food and Administration. Others, such as Color Genomics, Helix, and Veritas, don’t need the agency’s approval because they require a physician order. However, physician involvement is often solicited by the companies on behalf of customers, who may never even meet the doctor.

The level of physician involvement beyond ordering the genetic tests is unclear and raises questions for some bioethicists, who worry that certain health information may be useless, or even harmful, when given outside the context of routine medical care. Some companies say having doctors thoroughly review orders and reject those deemed inappropriate maintains professional oversight.

Companies are still forging ahead despite potential regulation concerns. Rodrigo Martinez, MBA, chief marketing and design officer at Veritas, said his company hopes to eventually offer whole-genome sequencing with no physician involvement in the ordering process, as long as the company can figure out a responsible way to provide the data to customers.

Source: STAT News, March 16, 2018.