Theranos and COVID-19 Testing Are Mirror-Image Cautionary Tales

^{Photo by Steve Nomax on Unsplash}

Last week, prosecutors and defense attorneys made opening statements in the criminal trial of Elizabeth Holmes, the former CEO of Theranos, who is accused of defrauding investors and patients with false promises of cheap, rapid blood tests. The next day, the Biden administration announced a plan to purchase 280 million cheap, rapid COVID-19 tests—an action for which some lawmakers have been advocating for more than a year. The serendipity of these two events exposes an unresolved tension in health care: How do we balance the risks of disruptive innovation with the mortal costs of administrative inertia?

Theranos and COVID-19 testing are both cautionary tales of failed medical oversight, but the morals flip from one case to the other. Each addresses, in its way, how much control the FDA should exert over laboratory tests before they come to market. COVID-19 testing epitomizes the agency’s risk-averse instincts. In the first months of the coronavirus pandemic, the FDA notoriously delayed private labs from developing their own COVID-19 tests. This allowed the coronavirus to spread mostly...