The US Fast-Tracked a Coronavirus Test to Speed Up Diagnoses

Megan Molteni The FDA has given emergency authorization to a new test that promises to help public health labs meet a potential surge in cases.On Tuesday, the US Food and Drug Administration issued emergency authorization of a diagnostics test for the novel coronavirus that has sickened more than 20,000 people and killed 427 since emerging in China six weeks ago.The exemption will make the test—which was developed by the US Centers for Disease and Control and until now has been performed only in its laboratories—available to public health labs across the country. It’s also a sign that the world is starting to learn how to deal with an onslaught of new pathogens.“Outbreaks have become the new norm,” says Catharina Boehme, chief executive of Geneva-based nonprofit Foundation for Innovative New Diagnostics (FIND), which works with the World Health Organization to evaluate new testing technologies and expand diagnostic capacity in low-resource nations. In the last few years, catalyzed by failures to produce fast, reliable testing during the 2014 Ebola outbreak, global health organizations and governments have worked to put pre-agreements in place so that samples of the virus, which are needed to validate potential diagnostic tests, are accessible at an outbreak’s outset, not once it has already acquired momentum. Chinese health authorities released a draft genome of the virus in early January, which enabled labs like the CDC to develop diagnostic tests based on a standard technology known as reverse-transcriptase polymerase chain reaction, or RT-PCR.This kind of test requires designing small pieces of DNA that match sections of the viral genome that are distinctive from other coronaviruses—like the ones that cause SARS, MERS, and the common cold—but stable enough that they’re not going to mutate. Mammoth has not yet applied for an emergency use authorization with the FDA and is waiting on samples from the CDC and state public health department to validate the accuracy of its test.