FDA planning to issue LDT guidance

FDA has drafted a guidance document that lays out its plans for regulating laboratory-developed tests, FDA spokesperson Susan Laine told BioCentury on Monday. The agency is "proposing to regulate all in vitro diagnostic tests in the same risk-based framework the agency currently uses, whether or not they are performed by a single laboratory," she said. In remarks at the American Society of Clinical Oncology meeting on Sunday, FDA Commissioner Margaret Hamburg said the agency is "working to make sure that the accuracy and clinical validity of high-risk tests are established before they come to market." She said the "risk-based framework we have under development will ensure that diagnostics used in cancer treatment will provide medical professionals with a critical baseline for confidence in the tests they order for their patients." Laine said the guidance is "currently in administrative review" by the White House Office of Management and Budget, but did not provide an expected release date. ...