The FDA has finalized a divisive plan to regulate some lab tests, including those used to diagnose cancer and Alzheimer’s disease, over concerns about reliability and risk to patients.
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 cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” FDA Commissioner Robert M. Califf said in a news release. The FDA does not review most lab tests before patients use them. But it finalized a plan to phase in the regulation of lab tests over the course of four years. Many tests will now
The agency is allowing tests already in use to stay on the market without necessarily going through the FDA’s new rules — a move the agency says is intended to address the risk that the cost of compliance with new requirements could lead to the loss of tests patients rely on.a wide array of substances or markers in the body, such as proteins, glucose, cholesterol and DNA — all of which provide critical information about a patient’s health.
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