The U.S. Food and Drug Administration continues to struggle in its quest for a regulatory policy to unlock the potential of blood-based COVID-19 serology testing while reining in fraudulent marketing and accuracy challenges. Here is a look at the latest developments. The Diagnostic Challenge As the curve flattens and society turns to the business of reopening, a new kind of coronavirus diagnostic testing is needed, one that is capable of not only detecting SARS-CoV-2 antibodies in a person’s system but also determining whether they are due to a current or previous COVID-19 infection. In addition to enabling governments, employers and other decision makers to figure out if a person is “safe” for public activity or needs to be in quarantine, such data is crucial to tracking COVID-19 among specific populations. Because serology testing offers that potential, the U.S. Food and Drug Administration (FDA), the agency that has maintained air-tight control over unproven laboratory developed tests for over a decade, has relaxed its regulatory standards to an unprecedented degree, allowing tests beset with accuracy problems to reach the market without regulatory review. At the same time, it created a more rigorous pathway requiring Emergency Use Authorization (EUA) for higher quality serology […]