Future Of LDT Oversight Still Uncertain

After years of back-and-forth on the issue, the debate over which federal agency will regulate laboratory-developed tests (LDT) going forward is far from settled. The FDA says it has the statutory authority to regulate LDTs and will release a final guidance on LDT oversight this year. Meanwhile, some lawmakers and industry groups are circulating alternative proposals that would either give FDA more authority over LDTs or give the authority to CMS under an expanded CLIA program. Other groups are threatening litigation once the final guidance is released unless there are significant changes that make the new framework more palatable. Currently there are several alternate proposals being floated around Capitol Hill. Two, put forth by AMP and CAP, are similar in many ways, with both exempting low-risk tests from premarket reviews and giving CMS or third-party reviewers the sole authority to review moderate-risk tests. FDA would only be involved in review of high-risk tests. A third proposal, put forth by the House Energy and Commerce Committee, is based on an alternate framework drafted by the Diagnostic Test Working Group, a coalition of IVD companies and laboratories. This draft legislation would create a new FDA center for in vitro clinical tests, which would use a new standard reasonable assurance of analytical validity and clinical validity in reviewing all high-risk in vitro clinical tests, regardless of whether the test is offered by a laboratory or as a distributed product. FDA would handle premarket review of LDTs while CMS would continue oversight of laboratory operations.

Source: https://www.aacc.org/publications/cln/articles/2016/april/future-of-ldt-oversight-still-uncertain