FDA Clears Abbott Test For COVID-19

By Adam Lidgett
Law360 is providing free access to its coronavirus coverage to make sure all members of the legal community have accurate information in this time of uncertainty and change. Use the form below to sign up for any of our weekly newsletters. Signing up for any of our section newsletters will opt you in to the weekly Coronavirus briefing.

Sign up for our Health newsletter

You must correct or enter the following before you can sign up:

Select more newsletters to receive for free [+] Show less [-]

Thank You!

Law360 (March 19, 2020, 6:47 PM EDT) -- Abbott Laboratories has announced it will be sending out thousands of coronavirus tests after the U.S. Food and Drug Administration gave it the greenlight to sell the tests, a move that comes as the number of cases continues to sharply rise.

FDA Commissioner Stephen Hahn said in a Wednesday tweet that the agency has given so-called emergency use authorization for the molecular test, which the company said in its own announcement will be used on a system already available across the United States.

"A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it," Abbott's CEO and Chairman Miles D. White said in a statement.

The company said it will start shipping out 150,000 across the country, noting that they have already been sent to medical facilities in places such as New York, California and Massachusetts. Abbott said it is intent on "providing up to 1 million tests per week."

Abbott said that the tests will be done using its m2000 RealTime System, which is already being used in labs and medical facilities in the United States. Even though the system, which can run hundreds of tests a day, is in use in various places, the company said that it would try to send out more as needed.

The World Health Organization last week declared COVID-19 a pandemic — a disease that has spread across the world.

According to the Johns Hopkins University Coronavirus Resource Center, which is tracking the pandemic, there have been more than 9,800 deaths globally as of Thursday afternoon.

In the U.S., there have been more than 170 deaths as of Thursday afternoon, according to the university's tracker.

The FDA earlier this week said it would allow medical device makers to distribute unapproved diagnostic tests and allow states to unilaterally authorize lab tests, in an effort to jump-start sluggish screening for the deadly coronavirus.

The FDA at the time laid out its new leeway guidance document and said that its relaxed oversight represents an "unprecedented policy" intended to tackle the "urgent public health concerns" of the coronavirus.

Recently, the FDA cleared tests developed by Roche AG and Thermo Fisher Scientific.

--Additional reporting by Jeff Overley. Editing by Jay Jackson Jr.

For a reprint of this article, please contact reprints@law360.com.

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!