Home-brew tests need regulation

摘要

On 18 April, the US Centers for Disease Control and Prevention (CDC) published an alert. The agency had learned of a new test being used to diagnose Lyme disease, a tick-borne bacterial infection that can cause fatigue, joint pain and nervous-system problems. The test, like many others for the disease, had not been formally evaluated and approved by governmental regulators, and agency scientists worried that the method would churn out too many false positives. But because of a regulatory loophole, there was little the CDC could do except ask consumers to avoid the tests and urge people to seek out the few diagnostics that had been approved by the US Food and Drug Administration (FDA).