Abbott Laboratories (NYSE:ABT) stock is set to start Thursday’s trading up around 10% as a rapid COVID-19 test capable of proving results within 15 minutes got the greenlight from the US Food and Drug Administration (FDA).
The FDA granted an Emergency Use Authorization (EUA) for Abbott’s BinaxNOW product for the detection of COVID-19 infection – the EUA is an authorisation for use and is not the same as an FDA clearance or an authorization.
Abbott will sell the tests at a price of US$5 per test.
The med-tech company intends to ship around 1mln tests a day and said it plans to ship ‘tens of millions’ of tests in September before ramping up to a rate of 50mln tests per month from the beginning of October.
Abbott notes that the BinaxNOW COVID-19 test is a “near-person rapid antigen test” and it can be used for “first line of defence” testing.
"The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing," said Joseph Petrosino, professor at Baylor College of Medicine which provided labs in the effort to develop COVID-19 tests.
He added: “With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."
The test kit is described as ‘highly portable’, about the size of a credit card, and the company is in parallel launching a complementary mobile app for iPhone and Android, called NAVICA.
It said the app will provide users with a temporary digital health pass which could allow organisations to view and verify the test results.
According to Abbott, the test has demonstrated 97.1% sensitivity of 97.1% and 98.5% specificity in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.
In New York, Abbott stock is up around US$10.31 or 9.99% priced at US$113.50 in premarket.
The test utilises what Abbott describes as a simple nasal swab to collect specimens from people suspected of having an active infection. The company said that no equipment is needed to process samples or read results, and minimal chemical reagents are required.
Abbott noted that it has developed multiple tests to help combat COVID-19, this latest one is its sixth. To date it has supplied some 27mln COVID-19 tests in the US, including 14mln detection kits and 13mln antibody tests.