The U.S. Food and Drug Administration is delaying a major effort to bring thousands of genetic tests under its purview, despite growing concerns that currently unregulated tests are wrongly identifying conditions from Lyme disease to cancer.
The FDA issued draft rules to greatly increase its coverage of the tests two years ago. Industry officials and observers widely anticipated the rules would be finalized before President Obama left office.
Yesterday, the agency statement said it was hoping to outline its new view of how to oversee the tests in the “near future” – and sent a clear signal there would be no action until president-elect Trump took office. Patients and health care providers “need accurate, reliable, and clinically valid tests to make good health care decisions—inaccurate or false test results can harm individual patients,” an FDA statement said Friday.
But the agency said it realizes “just how important it is that we continue to work with stakeholders, our new Administration, and Congress to get our approach right.” At issue are laboratory developed tests, which include many of the genetic tests created since the human genome was first sequenced over a decade ago.
As long as these tests are designed, manufactured, and used within a single laboratory, they can be sold without FDA approval, making it challenging for patients and doctors to know which have been proven accurate and which ones have not.
The laboratory community has long opposed regulation, saying it would stifle innovation and cost too much. Alan Mertz, president of The American Clinical Laboratory Association, called the FDA’s decision “a victory for diagnostic innovation and most importantly, patients.”
