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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

56 mins ago - World

Pope Francis denounces European governments' migrant response

Pope Francis adresses refugees at the Reception and Identification Centre (RIC) in Mytilene on the island of Lesbos on Sunday. Photo: Louisa Gouliamaki/Pool/AFP via Getty Images

Pope Francis criticized European countries' response to migrants and asylum seekers during his visit to a refugee camp on the Greek island of Lesbos Sunday.

Why it matters: The pope said "migration is a humanitarian crisis that concerns everyone," but little had changed in the global response to displaced peoples since his first visit to Lesbos five years ago, per a transcript of his remarks. "Human lives, real people, are at stake. ... let us stop this shipwreck of civilization!"

Chris Cuomo accuser: On-air "hypocrisy" spurred report

Journalist Chris Cuomo. Photo: Gilbert Carrasquillo/GC Images

A woman who accused fired CNN journalist Chris Cuomo of sexual misconduct said Sunday she decided to come forward after learning of his comments about women who made similar accusations about his brother. He denies her allegations.

Why it matters: Her attorney Debra Katz said in a statement that she heard "the hypocrisy" of his on-air words about his brother, former New York Gov. Andrew Cuomo, and was "disgusted by his efforts to try to discredit these women," so "retained counsel to report his serious sexual misconduct against her to CNN."

Updated 6 hours ago - Politics & Policy

Omicron dashboard

Illustration: Shoshana Gordon/Axios

  1. Health: CDC director says number of U.S. Omicron cases "likely to rise" — Two years of COVID-19 — Prior coronavirus infections may not protect well against Omicron.
  2. Vaccines: Data demonstrates most-vaccinated counties less vulnerable to worst of COVID — Omicron adds urgency to vaccinating world — Omicron fuels the case for COVID boosters.
  3. Politics: Nevada to impose insurance surcharge on unvaccinated state workers — New Jersey GOP lawmakers defy statehouse COVID policy — Oklahoma sues Biden administration over Pentagon vaccine mandate.
  4. World: Vaccine mandates lose steam in the U.S. while Europe doubles downWHO: Delta health measures help fight Omicron — COVID cases surge in South Africa in sign Omicron wave is coming.
  5. Variant tracker: Where different strains are spreading.