Abbott Laboratories will try its rapid Covid-19 test on asymptomatic people to determine its effectiveness, according to CEO Robert Ford.
The Food and Drug Administration (FDA) granted Abbott emergency use authorization late Wednesday for its new coronavirus antigen test.
The antigen test is the first coronavirus test that is only about $5 and presents results in minutes on a testing card without the use of any lab equipment. It works like a pregnancy test.
According to Abbott, it will “ship tens of millions of tests in September, ramping production to 50 million tests a month in October.”
A statement released by White House Press Secretary Kayleigh McEnany about the purchase of the rapid tests states that “Through Operation Warp Speed and in partnership with Abbott Laboratories, final production will be scaled to an unprecedented 50 million tests monthly.”
Beyond the FDA approval
Meanwhile, in a separate statement, the Department of Health and Human Services said that the rapid tests will be “potentially deployed to schools and to assist with serving other special needs populations.”
According to Ford, the company plans to expand beyond the current FDA approval.
“We are working on developing data for asymptomatic claims, so we are running our clinical trial, and we’ll eventually have data to be able to support that,” Ford told CNBC’s Meg Tirrell on “Power Lunch.”
A spokeswoman for Abbott Labs said there are no additional details on the clinical trials to present at this time.
“Due to the potential for decreased sensitivity compared to molecular assays, negative results from an antigen test may need to be confirmed with a molecular test prior to making treatment decisions,” the FDA said in its authorization of the BinaxNOW test.
“Negative results from an antigen test should be considered in the context of clinical observations, patient history and epidemiological information,” the agency said.
In a CNBC op-ed, Ford said that Abbott’s rapid antigen tests such as BinaxNOW are important because they remove the waiting game for results.
“Rapid tests deliver actionable results quickly so that infected patients can immediately begin self-quarantine. This test, along with others like it, is risk reduction on a societal scale,” Ford wrote.
While Abboty Laboratories holds its trial for the test with asymptomatic people, Ford stressed it can be delivered and applied in a number of beneficial settings.
“In the meantime, we see it being able to be deployed, because it doesn’t requirement an instrument … through the federal government, through the state governments, through schools, through employers, or even through retail clinics,” Ford said. “We think that’s a great opportunity to be able to line up this volume.”
“Rapid antigen tests perform well while eliminating the waiting game,” Ford wrote in his op-ed. “Rapid tests deliver actionable results quickly so that infected patients can immediately begin self-quarantine. This test, along with others like it, is risk reduction on a societal scale.”