FDA moves to regulate some tests it says may be unreliable

Original source (on modern site) | Article images: [1]

The Food and Drug Administration has finalized a divisive plan to regulate laboratory medical tests — including some used to diagnose cancer and Alzheimer's disease — over concerns about reliability and risks to patients.

The agency says inaccurate results may force patients to unnecessarily start a new treatment or delay care. Federal officials maintain that granting the FDA greater oversight will help ensure the tests are safe and effective, but critics contend the move will stifle the quick development of new tests.