Ellume COVID-19 home test: US awards $231M contract to provide over-the-counter kits

WASHINGTON - In an effort to increase the availability of testing for COVID-19, the U.S. government has awarded a $231.8 million contract to an Australian company behind the first fully at-home rapid coronavirus test — which can be obtained without a prescription.

The test, made by Ellume, can show results on an individual’s smartphone within 15 minutes of receiving a sample. The test kit includes a nasal swab, a chemical solution and a testing strip. The digital analyzer connects to a smartphone app, which displays the results and then helps to interpret them. Users can also connect with a health care professional on the app.

It’s one of only three tests that consumers can use themselves, and the only one available without a doctor’s prescription.

A provided image from Ellume shows its COVID-19 Home Test for over-the-counter home use in both symptomatic and asymptomatic individuals. (Photo credit: Ellume)

Since the onset of the coronavirus outbreak, health experts have stressed the need for fast, widespread home testing so that people can screen themselves and avoid contact with others if they have an infection. But the vast majority of tests still require a nasal swab performed by a health worker that must be processed at high-tech laboratories.

In December, the Ellume test received an Emergency Use Authorization from the U.S. Food and Drug Administration. Clinical trials showed it correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms, according to a statement by the FDA.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

Ellume’s test looks for viral proteins shed by COVID-19, which is different from the gold standard tests that look for the genetic material of the virus.

Like other tests that scan for proteins, FDA officials noted that Ellume’s test can deliver a small percentage of false-positive and false-negative results. People who get a negative result but have coronavirus symptoms should follow up with a health care professional, the agency said.

Ellume will deliver 8.5 million tests to the U.S. government that will be distributed across the country, as part of the new contract with the Department of Defense and in coordination with the Department of Health and Human Services.

The company said the new contract will also help fund Ellume’s first manufacturing facility in the U.S. Once completed, Ellume said it will produce more than 500,000 tests per day. At full capacity, the U.S facility will be able to produce up to 19 million tests per month, according to the company.

A company spokesperson said in December that the test will be priced around $30 and will be available at pharmacies and for purchase online.

The head of the U.S. Centers for Disease Control and Prevention said Monday that new COVID-19 cases and hospitalizations are down in recent weeks, but three new variants of the coronavirus have been detected in the U.S. that are causing concern.

RELATED: Coronavirus variant P.1 surging in Brazil 'deeply worrying,' experts say

To prevent further mutations, public health experts like Dr. Anthony Fauci, the nation’s top infectious-disease expert, have called on Americans to get the vaccine as soon as they’re eligible. 

"Viruses cannot mutate if they don’t replicate," Fauci said. "And if you stop their replication by vaccinating widely and not giving the virus an open playing field to continue to respond to the pressures that you put on it, you will not get mutations."

Fauci added that vaccine makers should be "nimble to be able to adjust readily" to make tweaks to the vaccines if needed.

The more serious strains have created a new urgency to speed up vaccinations. The White House said 1 million doses will be distributed to some 6,500 pharmacies across the country next week, and it has boosted the weekly allocation of vaccines sent directly to states and territories.

The Biden administration has announced a goal of 300 million vaccinated Americans by the end of summer. 

RELATED: CDC study urges more ‘efficient and equitable administration’ of COVID-19 vaccines

This story was reported from Cincinnati. The Associated Press contributed.