President Trump holds the Abbott Labs coronavirus test at the White House on March 30. Photo: Win McNamee/Getty Images

The FDA has received at least 15 reports that suggest Abbott Labs coronavirus tests are inaccurately telling patients that they do not have the virus, FDA said in a Thursday press release citing early data.

Why it matters: These tests have been widely distributed by the federal government in response to the pandemic. The U.S. deployed over 235,000 tests to public health laboratories in every state across the U.S., Assistant Secretary of Health Adm. Brett Giroir said on Monday.

What they're saying: "We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test," Tim Stenzel of the FDA's Center for Devices and Radiological Health said in a statement.

  • "This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test," he said.
  • Specifically, the FDA says that Abbott tests may be incorrectly telling users that they do not have the coronavirus.

What's next: The FDA says it is working with Abbott to review reports of inaccurate test results. Abbott has agreed to conduct further clinical studies on how the tests interact with COVID-19 positive patients, the agency said.

Go deeper: AMA cautions use of coronavirus antibody tests to determine "immunity"

Go deeper

Aug 21, 2020 - Health

Trump administration blocks FDA from regulating lab-developed tests

Photo: Pier Marco Tacca/Getty Images

The Department of Health and Human Services this week blocked the Food and Drug Administration's ability to regulate lab-developed tests, including for the coronavirus, that have been produced by hundreds of hospitals.

What they're saying: The change prohibits the FDA from overseeing such tests before they're marketed without a detailed rule-making process. HHS said it is taking the action as part of broader Trump administration review of "duplicative actions and unnecessary policies."

Bryan Walsh, author of Future
Aug 22, 2020 - Health

Better testing can fight more than the pandemic

Illustration: Eniola Odetunde/Axios

New coronavirus diagnostics could eventually enable near-constant testing — and herald a future where even common infections no longer go undiagnosed.

Why it matters: Rapid testing could be especially important during the winter, when it will become vital to quickly distinguish between an ordinary cold or flu and a new disease like COVID-19.

Updated 3 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

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