The FDA Should Stay Away from Laboratory Developed Tests

Source: Independent Institute
by Raymond J March

“In healthcare, tests are our eyes into the body’s secretive operations. Whether being swabbed for COVID-19, tested for a genetic condition, taken a drug test, or undergoing routine blood work ordered by your doctor, you’ve likely used a laboratory developed test (LDT). About 70 percent of all medical decisions in the US are based on LDT results. LDTs, developed in-house by laboratories and administered to patients through physician approval, have long been the unsung heroes in medical diagnostics. While laboratories adhere to many federal and state regulations, LDTs receive significantly less oversight. They are fostering innovation and responsiveness to emergent health threats. Now, the Food and Drug Administration is trying to change that.” (11/16/23)