FDA wants to regulate thousands of lab tests that have long skirted oversight

By MATTHEW PERRONE
AP Health Writer

WASHINGTON (AP) — The Food and Drug Administration says it plans to begin regulating laboratory-based medical tests. It’s a multibillion-dollar industry that regulators say poses a growing risk to patients. The agency’s proposed rule was announced Friday. It would formally bring thousands of tests performed in large laboratories under FDA oversight. It also would end decades of regulatory ambiguity. Regulators say the change will help ensure tests used to diagnose cancer, heart disease and thousands of other conditions are safe, accurate and reliable. The FDA will take comments on its proposal for 60 days before beginning to write a final rule.