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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

Recently, Representatives Larry Bucshon (R-IN) and Dianne DeGette (D-CO) introduced 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

11.30.2018: Modernization of CLIA: LDTs

04.20.2017: Oversight of Laboratory Developed Tests

AACC Letters to Congress

03.27.2020: AACC Endorses S.3512, the Verified Innovative Testing in American Laboratories (VITAL) Act

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

02.28.2020: AACC Calls on FDA to Allow Clinical Labs to Develop Their Own Tests for the Coronavirus

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