As the nation grapples with the grim milestone of half a million deaths due to the pandemic, an over-the-counter (OTC), in-home COVID-19 test is on the horizon.
The test, produced by Australia-based Ellume, detects infection by locating antigens, which are proteins produced by the virus.
The federal government recently announced a $231.8 million contract with Ellume. In the coming weeks, the company is expected to announce the location of its U.S. manufacturing facility.
It’s projected the company’s U.S. manufacturing will generate 1,000 jobs. By year’s end, the facility is expecting to produce 19 million tests per month.
“Ellume will be delivering 100,000 tests per day from the Australian factory until the U.S. plant is up and running,” Sarah Bortman, a company spokeswoman tells WorkingNation.
Ellume plans to deliver 20 million home tests to the U.S. within the first half of the current year. As part of its contract with the Department of Defense, 8.5 million Ellume tests are designated for use by the federal government.
Ellume’s is the first OTC, in-home test approved for sale in U.S. stores by the Food and Drug Administration (FDA). It includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with a smartphone app. Users follow instructions for taking the test by watching a video via the app.
The test provides results within 15 minutes. Results can be shared with health care providers through a secure cloud connection.
Because of the possibility of false negatives, company officials do not consider the test a stand-alone solution.
Awaiting FDA Approval
San Diego-based Quidel Corporation is awaiting FDA approval for its own over-the-counter, at-home test. The company already received approval last year for six COVID tests used across a variety of diagnostic equipment found in hospitals and medical labs.
Quidel recently announced a new facility in nearby Carlsbad that should be operational in the second half of this year. The company is currently seeking Emergency Use Authorization (EUA) for its QuickVue test to be sold directly to consumers.
Quidel is actively hiring to fill open positions including engineers, chemists, technicians, manufacturing, purchasing, sourcing, and support services.
As of Monday, the U.S. had completed more than 323 million COVID-19 tests, according to the Centers for Disease Control.