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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Although CLIA provides robust safeguards, there is concern that the regulatory framework is becoming outdated as LDTs grow increasingly numerous and complex. Among regulators and stakeholders there is an ongoing debate over the appropriate level of regulation for LDTs.

Food and Drug Administration

Draft legislation known as the Verifying Accurate, Leading-edge IVCT Diagnostics (VALID) Act proposes to address the issue by establishing a new regulatory framework overseen by the Food and Drug Administration (FDA). 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).

AACC supports risk-based regulation but is concerned that expanded FDA oversight will prove burdensome for labs and inevitably reduce the number of LDTs being performed. While additional oversight may be warranted for certain high-risk tests, the regulation of LDTs should remain with CMS under CLIA in order to protect patient access to these critical tests.

Additional Resources

AACC Position Statements

11.30.2018: Modernization of CLIA: LDTs
04.20.2017: Oversight of Laboratory Developed Tests

AACC Letters to Congress

02.11.2019: AACC Responds to Congressional Request for Feedback on Draft LDT Bill
08.20.2018: AACC Provides Feedback on FDA DAIA Comments
06.21.2018: AACC Opposes Legislation to Expand FDA Oversight of LDTs
04.06.2017: AACC Submits Comments to Reps. Bucshon and DeGette Regarding the Diagnostic Accuracy and Innovation Act
09.19.2016: AACC Input to Senate HELP Committee on LDT Regulatory Oversight
05.16.2016: AACC Urges Senate Delay of LDT Guidance
05.04.2016: AACC Supports House Language Delaying FDA LDT Guidance
11.17.2015: AACC Raises Concerns About Expanded FDA Oversight of LDTs
01.05.2015: AACC Provides Input to the House Energy and Commerce Committee Regarding LDTs

AACC Letters to FDA

01.29.2015: AACC Urges FDA to Maintain the Existing Regulatory Structure for LDTs
01.29.2015: AACC Provides Input Regarding FDA’s Notification and Medical Device Reporting Proposals for LDTs
01.08.2015: AACC Provides Testimony at the FDA Workshop on the Regulation of LDTs

Government Resources

VALID Act Draft Text
HHS Technical Assistance on VALID
DAIA Act Summary
FDA Technical Assistance on DAIA