Abbott’s rapid COVID-19 test receives FDA approval for at-home use; can be shipped to consumers’ homes

Abdel Jimenez, Chicago Tribune

Abbott Laboratories said Wednesday it received federal emergency use authorization for its rapid COVID-19 test to be used at peoples’ homes, with results available in 15 minutes.

The medical device company is the latest to win emergency approval for an at-home coronavirus test from the Food and Drug Administration after Australian manufacturer Ellume received approval Tuesday to sell its test at drugstores.

The announcement comes at a time when the nation is seeing a spike in COVID-19 cases and a vaccine made by Pfizer, initially administered to health care workers, enters the market.

Abbott plans to make 30 million BinaxNOW rapid antigen tests available in the first quarter of 2021, with an additional 90 million tests in the second quarter, the company said in a news release Wednesday. The test will cost $25.

Abbott is partnering with digital health service provider eMed to deliver and oversee the administration of the tests. Dr. Patrice Harris, CEO of eMed, said the company plans to begin the process Jan. 1, starting with a questionnaire.

Abbott and eMed will require people to answer a series of questions through Abbott’s smartphone app Navica about their symptoms following guidelines on testing from the Centers for Disease Control and Prevention in order to receive a test, Harris said.

Once eligibility is determined, eMed will ship the test kits, which include a nasal swab and test card, within 24 hours, she said. Then, individuals must begin a video session under the supervision of a certified eMed guide, whose role is to authenticate and confirm that tests are done properly, Harris said.

“That’s what really sets us apart,” she said.

Before receiving FDA emergency approval, Abbott’s rapid test was administered by health care providers.

Harris said the company is working with states to determine options for people to pick up test kits at places like pharmacies.

Ellume’s COVID-19 rapid test is the first at-home test that doesn’t require a prescription and costs $30, with results ready in about 20 minutes. The company said it expects to produce 3 million tests next month before it increases production over the first half of 2021.