Exclusive: Fully at-home rapid COVID test to move forward
Two companies behind an at-home rapid COVID-19 test are releasing encouraging clinical trial results ahead of applying for an emergency use authorization (EUA), company executives tell Axios.
Why it matters: Antigen tests that could quickly provide results at home would be a major help in identifying and slowing the spread of COVID-19, but they have to get into the hands of consumers at an affordable price.
Driving the news: Cellex, a biotechnology company, and Gauss, a computer vision startup, are announcing today that their rapid at-home coronavirus test achieved sensitivity rates of 94% and specificity rates of 97% compared to the PCR gold standard of lab tests, in a recent clinical trial.
- Sensitivity refers to a test's ability to identify true positive cases, while specificity refers to its ability to find true negatives.
- Those results are encouraging enough for the companies to move forward for an application for an EUA from the FDA, which is needed to fast track the test for home use.
The big picture: Cellex and Gauss are among dozens of companies racing to produce and market rapid at-home tests, but according to the Washington Post this week, no firm has yet applied to the FDA for authorization.
- One concern about at-home tests is that the results may not flow to officials, leaving them in the dark on COVID-19 spread, though Cellex and Gauss have partnered with a data integration platform to transmit test results.
The bottom line: Cheap at-home tests could be a game changer for the pandemic, but only if they're accurate — and only if people take steps to isolate themselves after a positive result.