2010 |
March |
NIH announced creation of Genetic Testing Registry to be launched in 2011 |
May |
Pathway Genomics announced Walgreens partnership to sell genetic testing kit at over 6000 retail stores |
FDA notified Pathway that kit appeared to meet criteria for medical device, and thus required FDA approval |
June |
FDA sends similar letter to five other companies (Knome, Navigenics, deCODE, 23andMe, Illumina) |
July |
FDA sends similar letter to 15 additional DTC companies |
FDA holds public meeting on how the Agency should regulate LDTs |
Congressional Committee holds hearing on ‘DTC Genetic Testing and Consequences to the Public Health’ |
GAO report on DTC genetic testing and ‘sting’ operation released |
2011 |
February |
AMA sends letter to FDA suggesting that all genetic testing be done under the guidance of a physician |
March |
FDA holds meeting to discuss the regulation of DTC genetic testing (Molecular and Clinical Genetics Panel) |
May |
FDA sends letter to three additional DTC companies |