A nasal swab from a coronavirus test. Photo: Ben Hasty/MediaNews Group/Reading Eagle via Getty Images

In terms of regulatory flexibility, the FDA's approach to coronavirus antibody testing is a 180-degree turn from its approach to diagnostic testing.

The big picture: The antibody tests, also known as serological tests, essentially detect whether someone's immune system has reacted to the coronavirus, helping determine whether they have had it — regardless of whether they had symptoms.

  • The tests will help determine how widespread the coronavirus outbreak has been, something currently unknown because of diagnostic testing failures.

By the numbers: Only one test has received an emergency use authorization from the FDA , but more than 80 test developers have notified the agency that they have non-authorized tests available for use, which is allowed.

  • The agency eventually adopted a similarly flexible approach to diagnostic tests.
  • But the Trump administration has been widely criticized for its early decisions to rely on tests made by the CDC, and for being slow to allow commercial and academic labs to participate.

Yes, but: The FDA's rationale for keeping a close hold on who was making coronavirus tests was that it was important for the tests to be accurate.

  • Scott Becker, executive director of the Association of Public Health Laboratories, has raised concerns about questionable serological tests that have appeared on the market, and has voiced these concerns about the "wild, wild West" environment to the administration, per the Washington Post.

Go deeper: Why the U.S. is so far behind on coronavirus testing

Go deeper

Updated 2 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Politics: Chris Christie: Wear a mask "or you may regret it — as I did" — Senate Democrats block vote on McConnell's targeted relief bill.
  2. Business: New state unemployment filings fall.
  3. Economy: Why the stimulus delay isn't a crisis (yet).
  4. Health: FDA approves Gilead's remdesivir as a coronavirus treatment How the pandemic might endMany U.S. deaths were avoidable.
  5. Education: Boston and Chicago send students back home for online learning.
  6. World: Spain and France exceed 1 million cases.

Early voting eclipses 2016 total with 12 days until election

People stand in line to vote early in Fairfax, Virginia in September. Photo: Tasos Katopodis/Getty Images

Americans have cast more than 47.1 million ballots in the 2020 presidential election, surpassing the total early-vote count for 2016 with 12 days left until Election Day, according to a Washington Post analysis of voting data.

Why it matters: The election is already underway, as many states have expanded early and mail-in voting options because of the coronavirus pandemic.

What to expect from the final debate of the 2020 election

Trump and Biden at the first debate. Morry Gash-Pool/Getty Image

Watch for President Trump to address Joe Biden as “the big guy” or “the chairman” at tonight's debate as a way of dramatizing the Hunter Biden emails. Hunter's former business partner Tony Bobulinski is expected to be a Trump debate guest.

The big picture: Trump's advisers universally view the first debate as a catastrophe — evidenced by a sharp plunge in Trump’s public and (more convincingly for them) private polling immediately following the debate.