Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools.
Many Americans might have assumed that the FDA already had oversight of all medical tests; it does not.
However, FDA Commissioner Dr. Robert Califf said the time is now to monitor the quality of high-tech tests for cancer, heart disease and a myriad other illnesses.
“A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” Califf explained in an FDA news release.
