The Food and Drug Administration (FDA) has decided to wait until the next administration is in office before deciding whether a largely unregulated class of laboratory tests should be subject to more rules.
Hospitals and private companies have developed and marketed tens of thousands of these so-called laboratory-developed tests, many of them meant to reveal the risk of cancer, heart disease or other maladies. They are designed, made and used in the same lab. The Mayo Clinic and the company Quest Diagnostics are two large providers of lab-designed tests in what The Wall Street Journal estimates is a multibillion-dollar market.
The problem, according to the FDA, is that lack of oversight of has led to a world where patients—or their insurance—might be paying for tests that don’t provide reliable results, or might be making decisions about surgery based on a false positive.