Table 1.
Targets of FDA Letters Concerning Genetic Tests
| June 10, 2010 Letters | July 19, 2010 Letters |
|---|---|
| 23andMe, Inc.; Personal Genome Service | Graceful Earth Inc.; Graceful Earth Alzheimer's Test |
| Pathway Genomics Corporation; Genetic Health Report | SeqWright DNA Technology Services, Inc.; Genomic Profiling Service |
| deCODE Genetics; deCODEme Complete Scan | Interleukin Genetics, Inc.; Inerent Health |
| Navigenics; Navigenics Health Compass | DNATraits; Ashkenazi Jews Genetic Disease Panel |
| Illumina, Inc.; Illumina Infinium HumanHap550 Array | CyGene Direct; Metabolic Health Assessment DNA Analysis Test |
| Knowme, Inc.; KnowmeCOMPLETE | Consumer Genetics, LLC; AsthmaGEN DNA Test |
| Matrix Genomics, Inc.; Matrix Genomics Breast Cancer Panel | |
| The Genetic Testing Laboratories, Inc.; The Genetic Testing Laboratories DNA Predisposition Test | |
| Sequenom, Inc.; SEQureDx | |
| EnteroLab Reference Laboratory; Gene Test for Gluten Sensitivity/Celiac Sprue | |
| BioMarker Pharmaceuticals, Inc.; Gene Essence | |
| DNA Dimensions; Predisposition DNA Test | |
| HealthCheckUSA; HealthCheckUSA Celiac Disease DNA Test | |
| easyDNA; Genetic Predisposition Health Test |