Ellume, a startup that won a $232 million contract to manufacture more of its over-the-counter Covid-19 tests in the U.S., has started building a manufacturing facility in Maryland. In the longer term, it plans to use the site to prepare for future outbreaks and pandemics.
After insurers were mandated to cover at-home Covid-19 tests, more people tested at-home screenings for other conditions. As preventive tests declined significantly during the pandemic, insurers also turned to creative means to give people access.
Ellume, whose at-home Covid-19 test was cleared by the FDA in December, got a $232 million contract from the Department of Health and Human Services to deliver 8.5 million tests.
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Shots: The US FDA has granted EUA for Ellume COVID-19 home test for non-prescription home use in symptomatic and asymptomatic individuals aged ≥2yrs. The data submitted to the US FDA from an independently run, simulated home-setting clinical study of 198 subjects aged 2-82yrs, demonstrated 96% accuracy including 95% overall sensitivity & 97% specificity vs emergency …
The FDA authorized an at-home antigen test for Covid-19 developed by Ellume. It does not require a prescription.