The FDA has given its green light to a new coronavirus test from Abbott, which will be sold for $5 and fits entirely on a device about the size of a credit card.
The rapid antigen test is designed to deliver a reading from a nasal swab within 15 minutes and is paired with a free, optional smartphone app capable of logging and displaying COVID-19 test results—providing a “temporary digital health pass” that could help clear people for entry to places such as schools, hospitals, workplaces, airports and elsewhere.
"We intentionally designed the BinaxNOW test and Navica app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," Abbott President and CEO Robert Ford said.
"While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the Navica app is the digital network that allows people to share that information with those who need to know," Ford added.
The medtech manufacturer plans to ship tens of millions of the tests next month, before ramping up production to 50 million per month starting in October. Abbott said it has invested hundreds of millions of dollars in two new U.S. facilities this year to help produce the BinaxNOW tests. Since receiving its first FDA authorizations in March, the company said it has manufactured 14 million infection detection tests and 13 million antibody tests.
The test will be available with a prescription and performed by healthcare professionals including school nurses, medical assistants, pharmacists and employer occupational health specialists.
“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card. This means people will know if they have the virus in almost real-time,” said the FDA’s device center director, Jeff Shuren. “Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic.”
The lateral-flow diagnostic detects a specific protein found within the novel coronavirus—as well as its older sibling, the virus responsible for the 2003 SARS outbreak—and provides a visual result similar to a pregnancy test. The BinaxNOW card-based platform has also been used for respiratory syncytial virus, influenza and other diseases.
It is best used within the first seven days after symptoms appear, to help identify people who should isolate themselves to prevent the spread of the disease, Abbott said. In a clinical study, the test showed a false-positive rate of 1.5% and a false-negative rate of 2.9%.
In addition, according to a report today from Politico, the Trump administration has reached a $750 million deal with Abbott to purchase 150 million tests—which would amount to a substantial increase in U.S. testing capacity, with the country performing 22 million tests last month.
The deal is set to be officially announced this week, with the tests to be distributed to nursing homes, schools and other locations, the report said.
Editor's note: This story has been updated with additional information on the Trump administration's purchasing deal with Abbott.