As Bob Dylan wrote, ‘‘The times, they are a-changin’ ’’ While Dylan certainly had larger issues in mind than the state of the clinical laboratory industry, it still is a fair description of what is happening for laboratories right now.

For many years, clinical laboratory testing involved relatively simple blood and urine tests. The U.S. Food and Drug Administration (FDA) took a relatively ‘‘hands off’’ approach toward laboratory-developed tests (LDTs), exercising what the agency termed ‘‘enforcement discretion’’ for these tests, which are developed and used in-house by laboratories. But, in recent years, there has been a dramatic change in the nature of the clinical laboratory industry. The mapping of the human genome and more advanced analytic techniques have led to great advances in laboratory testing, most of which is more sophisticated and costly than the simple blood and urine tests that were laboratories’ bread and butter in the past. The FDA has become more concerned about the complexity of LDTs that laboratories oftentimes develop and market today. The FDA announced in 2014 that it is ready to bring regulation of LDTs under its enforcement umbrella for the first time, possibly affecting thousands of tests.

Originally published in Bloomberg BNA - April 27, 2016.