FDA Enters Public-Private Partnership To Evaluate COVID-19 Tests Amidst Concerns Over Efficacy

The US FDA is partnering with industry stakeholders and advocacy groups to investigate the long-term effectiveness of COVID-19 tests. The announcement follows recent moves by the agency to pull a slew of antibody tests from the market due to a high rate of false negatives and criticism from stakeholders, including lawmakers.

The concept of a safe handshake. Shaking hands in medical gloves on gray background

The US Food and Drug Administration is extending a public-private partnership it has already undertaken to assess COVID-19 therapies to also evaluate tests for the SARS-CoV-2 virus. The announcement comes after the agency pulled a number of serology tests from shelves after serious concerns about their effectiveness.

The agency said it has joined the Reagan-Udall Foundation for the Food and Drug Administration, and the Friends of Cancer Research in their COVID-19 Diagnostics Evidence Accelerator project. The...

More from Regulation

More from Policy & Regulation