Genetic testing advances have gotten ahead of federal regulators. That was a message delivered to lawmakers this week in a hearing on personalized laboratory-developed genetic tests. The tests examine genes and DNA to see if they indicate the presence of, or risk for developing, particular diseases or disorders, which can be used to develop treatment plans. A Government Accountability Office report in 2010 critiqued the quality of direct-to-consumer genetic tests and medical groups question the reliability of the information.
The Food and Drug Administration, which is tasked with regulating diagnostic testing, has held off focusing on the tests but has informed Congress that it will soon issue draft guidance regarding the oversight of laboratory-developed tests. However, while the agency is inching toward broader regulation, the process may take years.
CQ HealthBeat’s (@CQHealthTweet) Kerry Young reported on Wednesday on the varying testimony from cancer research groups who are urging stepped-up oversight of the tests and laboratory groups who question the authority and capability of the FDA to regulate testing. The FDA’s director of the Center for Devices and Radiological Health Jeffrey Shuren told the House panel that he will seek input on new regulations but noted, “whatever we come up with, we are not going to satisfy everyone.”