CDC Panel Calls For Oversight Of CLIA-Waived Labs

A Centers for Disease Control and Prevention advisory panel on Thursday (Nov. 10) recommended increasing oversight of clinical labs that have been granted a waiver, under the Clinical Laboratory Improvement Amendments, to diagnose patients using CLIA-waived tests. Advisers cited concerns that a lack of oversight could lead to lower-quality laboratory developed tests. The panel also recommended FDA ensure that specimens from self-collection devices originate from humans and that a new type of certificate be created for labs that analyze data...