Sen. Ed Markey, D-Massachusetts, has sent letters to CEOs of at-home COVID-19 test-makers, asking why tests are selling for as much as $12 apiece. In a letter sent today to Abbott CEO Robert Ford, for example, Markey cited a Reuters story from October 2021 in which British test-maker Mologic said that rapid antigen tests can […]
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Time recognizes Abbott offerings among this year’s 100 best inventions
Abbott (NYSE:ABT) was among a series of medtech companies to receive recognition from Time in its list of 2021’s best inventions. The list of the year’s top inventions included Abbott’s innovations twice, with a nod to its NeuroSphere Virtual Clinic and its at-home COVID-19 testing offerings. Get the full story at our sister site, Medical Design & Outsourcing.
Ellume’s at-home COVID-19 tests recall expands to more than 2 million
The FDA announced this week that a recall of Ellume at-home COVID-19 tests at risk of false positives has expanded to include more than 2 million. The Class I recall had only been in the hundreds of thousands of kits when first announced in October. The Australian company has stressed that the reliability of negative […]
5 at-home COVID-19 diagnostic tests you should know
The wait for a completely at-home COVID-19 test ended in November when the FDA authorized the first ones that enabled people to obtain samples and results at home. The agency since then has authorized five at-home COVID-19 tests for emergency use since the beginning of the pandemic. The kits are made to take a sample […]
Quidel wins FDA nod for at-home antigen test
The FDA issued an emergency use authorization today for the Quidel Corp. (NSDW:QDEL) QuickVue At-Home COVID-19 test, another antigen test to rapidly collect and test samples at home, without the need to send a sample to a laboratory for analysis. The QuickVue At-Home COVID-19 test is authorized for prescription home use with self-collected nasal swab […]
FDA issues mea culpa for early COVID-19 serology test nods
Early in the pandemic, when the numbers of asymptomatic COVID-19 cases were mounting, officials at the FDA decided to authorize the use of serology tests that laboratories had validated but that the agency hadn’t actually reviewed. Now two FDA officials are admitting that this was a mistake, but one the agency has learned from. In […]
Biden administration orders home COVID-19 tests
The U.S. Defense Dept. announced today that it awarded Ellume $231.8 to onshore production capacity of its Ellume COVID-19 home test. In coordination with the U.S. Dept. of Health and Human Services (HHS), the DoD contract is an industrial base expansion to allow Ellume to increase the production capacity of its home test by 640,000 […]
BREAKING: FDA authorizes first over-the-counter, fully at-home COVID-19 test
FDA announced today that it has granted an EUA for the Ellume COVID-19 Home — the first fully at-home test for the novel coronavirus that the agency is authorizing for over-the-counter sales. FDA last month OK’d an at-home test from Lucira, but it needs a prescription. The first authorization for a non-prescription COVID test came […]
NIH announces more than $98M in contracts for new COVID-19 testing tech
The National Institutes of Health today announced six new contracts worth $98.35 million for COVID-19 testing approaches to improve sample collection, processing and results. NIH awarded the contracts in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) as part of the Rapid Acceleration of Diagnostics (RADx) initiative. They cover innovations including integration with […]
