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Gauss/Cellex rapid at-home COVID-19 test. Photo: Courtesy of Gauss

Two companies behind an at-home rapid COVID-19 test are releasing encouraging clinical trial results ahead of applying for an emergency use authorization (EUA), company executives tell Axios.

Why it matters: Antigen tests that could quickly provide results at home would be a major help in identifying and slowing the spread of COVID-19, but they have to get into the hands of consumers at an affordable price.

Driving the news: Cellex, a biotechnology company, and Gauss, a computer vision startup, are announcing today that their rapid at-home coronavirus test achieved sensitivity rates of 94% and specificity rates of 97% compared to the PCR gold standard of lab tests, in a recent clinical trial.

  • Sensitivity refers to a test's ability to identify true positive cases, while specificity refers to its ability to find true negatives.
  • Those results are encouraging enough for the companies to move forward for an application for an EUA from the FDA, which is needed to fast track the test for home use.

The big picture: Cellex and Gauss are among dozens of companies racing to produce and market rapid at-home tests, but according to the Washington Post this week, no firm has yet applied to the FDA for authorization.

  • One concern about at-home tests is that the results may not flow to officials, leaving them in the dark on COVID-19 spread, though Cellex and Gauss have partnered with a data integration platform to transmit test results.

The bottom line: Cheap at-home tests could be a game changer for the pandemic, but only if they're accurate — and only if people take steps to isolate themselves after a positive result.

Go deeper

Jan 29, 2021 - Health

J&J says its one-shot vaccine is 66% effective against moderate to severe COVID

Photo: Thiago Prudêncio/SOPA Images/LightRocket via Getty Images

Johnson & Johnson announced Friday that its single-shot coronavirus vaccine was 66% effective in protecting against moderate to severe COVID-19 disease in Phase 3 trials, which was comprised of nearly 44,000 participants across eight countries.

Between the lines: The vaccine was 72% effective in the U.S., but only 57% effective in South Africa, where a more contagious variant has been spreading. It prevented 85% of severe infections and 100% of hospitalizations and deaths, according to the company.

Jan 29, 2021 - Health

Ex-CDC director Tom Frieden on the next COVID-19 vaccines

Americans fortunate enough to receive COVID vaccines now, outside of clinical trials, are getting shots made by either Pfizer or Moderna. But newly released data from Novavax and Johnson & Johnson suggests that more vaccines could be on the way, with J&J's requiring a single dose.

Axios Re:Cap digs into the news and why it matters with Tom Frieden, former head of the CDC, as COVID-19 variants spread globally.

Jan 29, 2021 - World

EU grants conditional approval of AstraZeneca vaccine

Photo: Sunil Ghosh/Hindustan Times via Getty Images

The European Commission on Friday granted conditional approval of the Oxford-AstraZeneca coronavirus vaccine for people 18 years and older.

Why it matters: This is the third vaccine to receive approval from the commission, coming hours after the Emergency Medicines Agency recommended its authorization.