Table 1.

Recent timeline of DTC genetic testing events

Year	Month	Event
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