The FDA approves Abbott’s home-use fast Covid take a look at for $ 25
Abbott Laboratories BinaxNow kit
The Food and Drug Administration announced on Wednesday that it has approved Abbott Labs’ rapid Covid-19 test for home use, despite doctors having to prescribe the test for patients.
The test, which is an antigen test that gives results in about 15 minutes, was previously only approved for trained personnel. With the new release, however, patients can test themselves at home with the virtual support of a doctor. It is the third test approved in the US that “can be used entirely at home,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a statement.
Abbott has partnered with telemedicine provider eMed to deliver the test, called BinaxNOW, which costs $ 25 for home use, at home and oversee the collection and testing process. Patients collect the sample themselves using a nasal swab, and an app helps control the testing process and provide results, Abbott said.
Anyone over the age of 15 who is suspected by their doctor to have Covid-19 and who is within the first seven days of symptoms appearing is eligible for the test, according to the FDA. The test can also be used on people 4 years and older, although an adult must collect the sample, according to the agency.
“The FDA continues to approve COVID-19 tests that will give more Americans access to more flexibility and options for testing,” said FDA Commissioner Dr. Stephen Hahn in a statement. “The BinaxNOW COVID-19 Ag home test will have a significant manufacturing base and have the potential to support testing for millions of people.”
Abbott expects to run 30 million tests at home in the first quarter of 2021 and an additional 90 million in the second quarter. The FDA noted that antigen tests are not as accurate as many molecular tests.
“As the pandemic has developed, the need for rapid tests has grown. Unfortunately, we still hear that many people cannot access tests as quickly as they need them,” said Robert Ford, Abbott President and CEO, in one Explanation. “That’s why Abbott is bringing our BinaxNOW rapid test and our NAVICA platform home.”
The FDA first approved the test for use by trained personnel in August, touting it as the first Covid-19 test, costing about $ 5 and providing results in minutes on a test card without laboratory equipment, similar to a pregnancy test. The US quickly bought 150 million of the tests for $ 750 million to expand testing capacity.
However, it costs $ 25 to use the test at home, more than what it costs in medical facilities, Abbott said Wednesday.
“The FDA’s approval of the BinaxNOW card test for home use means we should be running tens of millions of COVID-19 tests in the coming months that Americans can use without leaving their homes,” said Alex Azar, Minister of Health and human services, in a statement on Wednesday.
Approval comes after the FDA approved Ellume’s home Covid test on Tuesday. This product is approved for use by people aged 2 and over and does not require a prescription.