FDA Warning to 23andMe has No Impact on Genelex
As you may have heard, 23andMe was recently warned by the FDA to cease and desist selling its Personal Genome Service directly to consumers. Because Genelex does not sell its pharmacogenetic testing to consumers, we are not impacted in any way.
The FDA is concerned that patients receiving 23andMe DNA test results will take actions that would be deleterious to their health, such as changing their drug regimen, without consulting their physician.
Our policy at Genelex has always been that patients have a right to genetic analysis that may affect their treatment. However, the ordering, delivery and interpretation of all clinical laboratory tests -- including DNA analysis -- should be done by a licensed medical professional. Physicians and other prescribers are best qualified to place this complex information in the right context and help patients understand what the results mean and whether they need to take action.
Genelex is accredited, certified and licensed to perform high-complexity clinical testing in all US states, and has been a leader in pharmacogenetic testing and analysis since 2000. I hope this alleviates any confusion or concerns that may have resulted from these recent announcements. If you have any questions, please call us at 800-TEST-DNA.
Kristine Ashcraft, COO