By Sarah Duranske
In 1978, for the first time, an American woman could take a pregnancy test in the comfort of her own home. Critics claimed that home pregnancy tests only would be used by promiscuous or immoral women who were too ashamed to visit their doctors, but the appeal to women was undeniable.  Today, eight out of ten women learn they are pregnant from a home pregnancy test.
In the 1980s, as the AIDS crisis swept the nation, the FDA banned the use of at-home AIDS tests over fears of poor test reliability and insufficient counseling. Advocacy groups bolstered these fears by highlighting the suicide of a man who jumped off the Golden Gate Bridge after testing positive for HIV. But with improvements in testing technology and treatment options – and stymied by a stubbornly high infection rate – the FDA reversed its stance. It encouraged home test kit applications in 1990 and approved two home collection kits in 1996. Within a year, more than 175,000 people purchased kits, and the expanded screening was not associated with any increase in the suicide rate.
In 2013, the FDA shut down 23andMe’s health-related genetic tests due to concerns that users would act, or fail to act, to their detriment based on incorrect test results or unsupported clinical interpretations. In spite of experts’ concerns, 23andMe had genotyped around 400,000 individuals between its 2007 market entrance and the FDA’s 2013 action. Studies consistently demonstrate (for better or worse) that people don’t change their behavior based on genetic tests that report on disease risk.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.