FDA implements new rule to regulate lab tests

The Food and Drug Administration (FDA) finalized a rule on Monday to ensure accuracy in lab-developed tests (LDTs) that affect decisions for serious illnesses, including cancer treatment and newborn diagnostics.

The move comes in response to concerns about inaccurate tests leading to incorrect treatments for conditions such as heart disease, cancer, autism and Alzheimer’s.

Set to take effect in two months, the new FDA rule will determine which lab tests are complicated or high-stakes. Then it will see if the tests are accurate in diagnosis.

LTDs are usually developed and conducted within a single laboratory. It has grown into a $10 billion industry in the past 20 years. Such tests make up around 50% of all lab tests in the US, according to estimates by Grand View Research.