The company expanded a recall of its at-home Covid-19 tests due to a manufacturing error. The FDA upped the recall to a Class 1 recall, its most serious level, after noting a higher-than-acceptable false positive rate for the affected tests.
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.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.
After insurers were mandated to cover at-home Covid-19 tests, more people tested at-home screenings for other conditions, speakers said in a discussion hosted by MedCity INVEST. 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.
The FDA authorized an at-home antigen test for Covid-19 developed by Ellume. It does not require a prescription.