FDA Regulations for Liquid Biopsy

The FDA regulates liquid biopsies, which are tests that analyze blood samples to detect cancer or other diseases. These regulations ensure that the tests are safe, accurate, and effective. Before a liquid biopsy can be marketed, it must undergo a thorough review process, including evidence from clinical studies that show it performs as intended. The FDA monitors these tests to ensure they meet quality standards, protecting patients from unreliable results that could affect diagnosis and treatment decisions. Overall, these regulations aim to provide confidence in the reliability of liquid biopsy tests in clinical settings.