FDA grants emergency OK of Hologic's asymptomatic COVID-19 test

The FDA has granted emergency authorization to Hologic's COVID-19 test to treat asymptomatic people. 

It's the first test widely available specifically for screening asymptomatic people and those without other reasons to suspect COVID-19 infection. Hologic said it expects the test to play a key role in identifying early infection and helping to reopen schools, workplaces and the broader economy. 

The test, called the Panther Fusion test, can return results in about three hours, and machines can process more than 1,000 test results in 24 hours, Hologic said. 

"Accurately identifying individuals early in the course of infection — so they can quarantine before passing on the virus — is critical to stemming the spread of this pandemic," said Kevin Thornal, president of the diagnostic solutions division at Hologic. "The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available."

The FDA also authorized Hologic's pooling protocol, which enables labs to combine up to five patients' samples into a single tube for processing. If the result comes back negative, all five people are negative.All the negative samples are then retested to figure out who is infected.

This method of testing helps to monitor the virus's spread in large populations. Experts have said faster results are better than more precise tests that take several days.


Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars