Proposed Center Within FDA Could Streamline Approval Process for Lab-Developed Tests

Regulation of laboratory-developed tests (LDTs) has been vigorously debated for a while now, especially after the FDA announced that it'd develop a risk-based oversight framework for these tests, which are, by definition, designed, manufactured, and used within a single laboratory.

Reactions following the announcement were mixed: both the American Society of Clinical Oncology and the American Cancer Society Cancer Action Network supported the FDA’s action, citing a need for a stronger evidence base in diagnostics. However, the American Medical Association and the Association for Molecular Pathology, along with the testing industry’s trade group, the American Clinical Laboratory Association (ACLA), opposed the move. ACLA wants regulation of LDTs to fall under CMS' Clinical Laboratory Improvement Amendments (CLIA) program, and have called for a modernization of the CLIA program instead.

Now, the House Energy and Commerce Committee (E&C) has developed a bill that classifies LDTs based on their characterization and the impact of an adverse result on public health. Additionally, timelines set within the bill would help accelerate the review/approval process within the FDA to improve public access to the tests. While the committee had a placeholder for LDTs in the original Cures bill, it was eliminated in the approved proposal and is now being floated as an independent bill.

While the final decision for approving or rejecting the LDT lies with the FDA, they have to provide the test-developer the rational behind their decision within a 60-day period. While establishing clinical utility is not a requirement for high-risk tests, manufacturers/developers have to ensure analytical and clnical validity of the test. Moderate-risk tests, the bill proposes, would only need data supporting analytical validity, and a "reasonable belief" that it is clinically valid for its proposed use.

The E&C draft's proposed “Center for In Vitro Clinical Tests” would be responsible for the implementation of the new regulatory structure.