FDA Gives Emergency Authorization to a Coronavirus Test to Speed up Diagnoses

    “In the short term, there is a very-high-volume testing need.”


    The U.S. Food and Drug Administration (FDA) has issued emergency authorization of a diagnostic test for the new coronavirus, aka 2019-nCoV, which has sickened more than 24,000 people and killed 490 in China, while the United States has reported 11 confirmed cases.

    The diagnostic test, developed by the U.S. Centers for Disease and Control and Prevention (CDC), will now be available to labs across the nation.

    The FDA’s quick move signals the need for speed as the drug regulatory body has joined the effort to stop the spread of the new coronavirus.

    “This continues to be an evolving situation, and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA commissioner Stephen Hahn.

    Cases have continued to rising daily in thousands even after the Chinese officials quarantined nearly 35 million people in Wuhan, a city in China, where the outbreak started. Healthcare professionals in China say they do not have enough testing kits to diagnose.

    With the number of cases increasing, public health officials across the world are now beefing up their diagnostic tests in an attempt to stop the spread.

    The CDC test will now be available in any certified lab in the world – thanks to the FDA’s emergency authorization. In fact, the diagnostic tools have already been shipped to a repository where states and international partners can order them.

    Catharina Boehme, CEO of Foundation for Innovative New Diagnostics (FIND), said, “Outbreaks have become the new norm.”

    FIND works with the World Health Organization (WHO) to evaluate new diagnostic technologies and expand its capacity in low-resource countries.

    “There’s been a real cultural shift in how we deal with outbreaks toward more transparency and sharing,” said Boehme.

    In the United States, at least two startups – Mammoth Biosciences in San Francisco and Sherlock Biosciences in Cambridge, Massachusetts – have been working on developing diagnostic tools.

    Currently, the need for diagnostic tests to stop the spread of coronavirus remains most urgent in China.

    “I’ve not seen a rapidly evolving outbreak like this one ever before,” said Boehme. “In the short term, there is a very-high-volume testing need. But we know from past coronavirus outbreaks that continued testing will be required for quite some time.”