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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

CDC to cut guidance on quarantine period for coronavirus exposure

A health care worker oversees cars as people arrive to get tested for coronavirus at a testing site in Arlington, Virginia, on Tuesday. Photo: Olivier Douliery/AFP via Getty Images

The CDC will soon shorten its guidance for quarantine periods following exposure to COVID-19, AP reported Tuesday and Axios can confirm.

Why it matters: Quarantine helps prevent the spread of the coronavirus, which can occur before a person knows they're sick or if they're infected without feeling any symptoms. The current recommended period to stay home if exposed to the virus is 14 days. The CDC plans to amend this to 10 days or seven with a negative test, an official told Axios.

  • The CDC did not immediately respond to a request for comment.
Updated 5 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Health: Nursing homes are still getting pummeledU.S. could hit herd immunity by end of summer 2021 if Americans embrace virus vaccines, Fauci says.
  2. Politics: Pelosi, Schumer call on McConnell to adopt bipartisan $900B stimulus framework.
  3. World: U.K. clears Pfizer-BioNTech vaccine for mass rollout — Putin says Russia will begin large-scale vaccination next week.
  4. Business: Investors are finally starting to take their money out of safe-haven Treasuries.
  5. Sports: The end of COVID’s grip on sports may be in sight.
Dec 1, 2020 - Health

CDC panel: COVID vaccines should go to health workers, long-term care residents first

Hospital staff work in the COVID-19 intensive care unit in Houston. Photo: Go Nakamura via Getty

Health-care workers and nursing home residents should be at the front of the line to get coronavirus vaccines in the United States once they’re cleared and available for public use, an independent CDC panel recommended in a 13-1 emergency vote on Tuesday, per CNBC.

Why it matters: Recent developments in COVID-19 vaccines have accelerated the timeline for distribution as vaccines developed by Pfizer and Moderna undergo the federal approval process. States are preparing to begin distributing as soon as two weeks from now.