Abbott Virus Antibody Test Gets FDA Emergency Clearance

Abbott Labs' coronavirus antibody blood test was cleared by the Food and Drug Administration for emergency use.
Author:
Publish date:

Abbott Labs  (ABT) - Get Report said the U.S. Food and Drug Administration issued an emergency-use authorization for the company's coronavirus blood test.

Abbott now plans to ship nearly 30 million antibody tests globally in May, with capacity for 60 million tests to be delivered in June. 

"Having more options of highly reliable tests across our platforms will help health-care workers and health officials as they conduct broad scale testing for covid-19," Chief Executive Robert B. Ford said in a statement. 

"Abbott is a leader in providing antibody testing at large scale on multiple systems, which is helping meet the needs of laboratories as they look to build testing capacity."

The antibody test from the Abbott Park, Ill., company last week received a vote of confidence from researchers at the University of Washington via the Journal of Clinical Microbiology. 

The group said the test "demonstrates excellent analytical performance." 

The researchers found that Abbott's SARS-CoV-2 IgG lab-based serology blood test had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in patients 17 days or more after covid-19 symptoms began. 

The FDA's emergency-use authorization means a company can market an unapproved medical product in an emergency to diagnose, test or prevent serious life-threatening diseases. Or similarly, an approved medical product can be marketed for an unapproved use. These apply when no adequate and approved alternatives are available, the FDA says.

The FDA has approved numerous emergency-use orders for coronavirus testing over the past few months. 

In just the first week on May the FDA granted emergency-use authorization more than a dozen times for different tests related to covid-19. 

Abbott Labs shares at last check were rising 0.7% to $94.32. 

Quidel Rapid Covid-19 Test Wins Emergency FDA Clearance