Video above: What does a false positive coronavirus test result mean? Due to a recently identified manufacturing issue, the U.S. Food and Drug Administration (FDA) is warning the public of the ...

WASHINGTON - In an effort to increase the availability of testing for COVID-19, the U.S. government has awarded a $231.8 million contract to an Australian company behind the first fully at-home rapid ...

A class action complaint was filed against Ellume USA LLC after the company recalled millions of at-home COVID-19 test kits last year. The complaint alleges Ellume is "unjustly retaining the monies ...

Oct 6 (Reuters) - Australian diagnostic test maker Ellume has recalled some lots of its COVID-19 home test, saying they may show false-positive results due to a recently identified manufacturing issue ...

In a major step toward ending the coronavirus pandemic, the United States Food and Drug Administration granted emergency use authorization for the first over-the-counter COVID-19 test for use at home ...

WASHINGTON -- The first home test for COVID-19 that doesn't require a prescription will soon be on U.S. store shelves. U.S. regulators Tuesday authorized the rapid coronavirus test, which can be done ...

The Biden administration announced on Monday that the US Department of Defense and US Department of Health and Human Services are working with Australian company Ellume to provide more of its fully at ...

Apr. 1—Australian-based biopharmaceutical company Ellume Ltd. officially opened a new facility in Frederick on Thursday, its first U.S. manufacturing location. The 215,000-square-foot facility, ...

WASHINGTON, D.C. — A home test for COVID-19 will soon be on U.S. store shelves. The U.S. Food and Drug Administration (FDA) on Tuesday issued an emergency use authorization for the first kit that ...