Sure Genomics Offering $2,500 Whole Human Genome Profile to Consumers, but ‘Doctor Prescribed’ Medical Laboratory Test Caught the Attention of the FDA
FDA sends letter to the California-based start-up concerning clearance for SureDNA test kit before accepting pre-orders from consumers
Competition to market whole-human genome sequencing to consumers is heating up. Not only is the Food and Drug Administration (FDA) watching these developments, but it is taking action to regulate companies that offer direct-to-consumer whole-human genome sequencing in developments that should be watched by clinical laboratory managers and pathologists.
One example is Sure Genomics. It claims to be breaking barriers by offering a $2,500 at-home whole human genome test to consumers.
The company believed the new test kit, called SureDNA, would escape FDA restrictions on the direct sale of health reports to consumers. However, the FDA’s recent letter to the California-based startup indicates Sure Genomics may face the same regulatory roadblocks that have stymied other direct-to-consumer genetic testing companies. (more…)