FDA grants emergency use authorization to Abbott Labs' new coronavirus antibody test
- Abbott plans to ship nearly 30 million tests this month and will have the capacity to ship 60 million tests in June.
- The tests can indicate whether a person has had Covid-19 and was either asymptomatic or recovered.
The Food and Drug Administration granted emergency use authorization for Abbott Laboratories' new coronavirus test that detects Covid-19 antibodies, the company announced Monday.
Abbott said it plans to ship nearly 30 million tests this month and will have the capacity to ship 60 million tests in June.
The tests can indicate whether a person has had Covid-19 and was either asymptomatic or recovered.
"Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for Covid-19," Abbott CEO Robert Ford said in a statement.
The authorization means laboratories will be allowed to use the test even though it has not been formally approved or cleared by the FDA.
U.S. officials and corporations across America are pouring money into antibody testing, hoping it will give people the confidence to return to work and reopen parts of the economy. President Donald Trump has recommended states use the tests as they start relaxing some of the strict social distancing measures imposed to combat the pandemic, which has infected more than 1.3 million people across the United States, according to data compiled by Johns Hopkins University.
Last week, the FDA tightened rules for coronavirus antibody tests, ordering manufacturers to submit emergency use authorization forms within 10 days.
Since the FDA issued its initial antibody test policy in mid-March, the agency said it has become aware of "a concerning number" of commercial serology tests being promoted inappropriately, including for diagnostic use, or performing poorly.
This is Abbott's fourth Covid-19 test to win emergency use authorization. Abbott had already launched three coronavirus tests in the United States, including a rapid test that produces results in as little as five minutes and the newly released test that shows if a person has antibodies against the virus.
The company announced last month that it was working with CVS Health to get its tests "outside of the hospital" and into places like urgent-care clinics and nursing homes.
Abbott said the new test is more efficient and can provide more tests and take up less space, an important feature the company said for labs that process tens of thousands of patient samples but are often short on space.
It can exclude false positives 99.6% of the time and exclude false negatives 100% of the time for patients tested 14 days after symptoms began, the company said Monday.
It plans to submit for European CE mark approval this week.