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 last week, but samples from the LabCorp test need to go to a lab for processing.
Elume’s test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on a smartphone. The app provides step-by-step video instructions to perform the test. Results show up on the user’s smartphone in fewer than 15 minutes, with options to share the results with healthcare professionals, health authorities, employers and educators.
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic,” FDA commissioner Dr. Stephen Hahn said in a news release.
Ellume (Valencia, Calif.) received $30 million from NIH in October to further the development of the device. The company said last week that it has expanded its manufacturing facility in Brisbane, Australia, and rapidly expanded its manufacturing efforts and supply chain in the U.S.
Production has started, with a goal of ramping up to more than 100,000 tests a day starting in January. Ellume plans to manufacture and deliver 20 million of the tests to the U.S. during the first half of 2021.
A simulated home-use clinical study of 198 subjects, ages 2 to 82, found Ellume’s test had an overall sensitivity of 95% (positive percent agreement) and specificity of 97% (negative percent agreement) when compared to an emergency use-authorized RT-PCR laboratory test, according to Ellume.