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