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 ...

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 ...

An Australian company that clinched the first US clearance for its at-home Covid-19 test kit has collapsed into liquidation after a sale to a competitor fell through. Covid-19 test maker Ellume Ltd.’s ...

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 ...