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Reforming Oversight of Essential Laboratory Developed Tests

LDTLaboratory developed tests (LDTs) are proprietary tests that clinical labs create for in-house use whenever a commercial test does not exist or is not appropriate for a particular patient health issue. For example, a lab may develop an LDT to monitor a rare disease or screen for a new designer drug. These tests are at the cutting edge of clinical laboratory science and play a vital role in providing quality healthcare in the face of patients’ changing medical needs.

Regulation of LDTs is currently overseen by the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Act (CLIA). Under CLIA, laboratories are required to clinically and analytically validate any LDTs and adhere to strict quality control and proficiency standards.

Although CLIA provides robust safeguards, there has been an ongoing debate over whether Food and Drug Administration (FDA) regulation is more appropriate for LDTs. The coronavirus pandemic has reinvigorated this debate and vividly illustrated the stakes as clinical laboratories struggled to rapidly scale-up testing in the face of significant regulatory obstacles from FDA’s emergency use authorization requirements.

Food and Drug Administration

In 2021, Representatives Larry Bucshon (R-IN) and Dianne DeGette (D-CO) reintroduced legislation, the Verifying Accurate, Leading-edge IVCT Diagnostics (VALID) Act, which would expand FDA oversight of LDTs and reduce CMS’ oversight responsibilities. VALID adheres closely to a framework outlined in a Technical Assistance document issued by FDA for a previous proposal known as the Diagnostic Accuracy and Innovation Act (DAIA).

As the real-world implications of FDA regulation have become evident, many observers in the lab community have questioned the wisdom of putting the agency in charge of regulating LDTs. The Verified Innovative Testing in American Laboratories (VITAL) Act, introduced by Sen. Rand Paul, responds to those concerns and seeks to codify LDTs as solely under the purview of CLIA.

AACC has long maintained that any update to the regulation of LDTs should occur through CLIA and the association endorsed VITAL shortly after its introduction. The coronavirus pandemic has underscored the association’s concern that FDA oversight of LDTs will prove burdensome and inevitably limit patient access to these critical tests.

Additional Resources

AACC Position Statements

Policy Briefs

Video Presentations

AACC Letters to Congress

AACC Letters to FDA

From Other Organizations

Government Resources