Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of laboratory developed testing procedures during the COVID-19 response. Unlike a recent bipartisan House bill, the Senate bill does not include a role for the U.S. Food and Drug Administration (FDA) in regulating laboratory developed tests.

On 17 March 2020 Sen. Rand Paul introduced S. 3512, the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020.  According to Sen. Paul, the VITAL Act would help diagnostic and prognostic tests become available more quickly during public health emergencies by securely placing laboratory developed testing services solely under the oversight of the Center for Medicare and Medicaid Services (CMS) pursuant section 353 of the Public Health Service Act, as updated by the Clinical Laboratory Improvement Amendments (CLIA provisions).  At the same time, the VITAL Act would exclude FDA from any oversight role in regard to laboratory developed testing procedures, even during a public health emergency.   This bill is in contrast to the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, introduced into the House on 5 March 2020, which would install a regulatory framework for a new product paradigm called in vitro clinical tests (IVCTs), encapsulating laboratory developed tests (LDTs), traditional in vitro diagnostics (IVDs) assays sold to laboratories by manufacturers, and other tests and test components.  Under the VALID Act, IVCTs would all be regulated by FDA. 

The VITAL Act defines a laboratory developed testing procedure  as “a professional medical service that utilizes a laboratory examination in the context of clinical care or public health services and that meets the standards for establishment of performance and specification established by regulation under [the CLIA provisions] applicable to:”

  • laboratory-modifications of test systems approved, cleared, or authorized by FDA;
  • methods developed or performed, and results produced and interpreted, within a laboratory or laboratories under common ownership or within the same organization that is CLIA certified;
  • standardized methods (e.g., textbooks and peer-reviewed publications); or
  • methods in which performance specifications are not provided by the manufacturer of test systems or components. 

This would expand on the currently accepted definition of a laboratory developed test (as outlined in FDA’s long-standing “enforcement discretion” framework for such services), which is an IVD that is designed, manufactured and used within a single laboratory.  According to Sen. Paul, the U.S. response to the present COVID-19 pandemic was hampered in part because the FDA initially required all tests to obtain emergency use authorization (EUA) before being used on patients.  By allowing laboratories to follow the CLIA process during public emergencies, Sen. Paul argues that the delays in making testing available and the inability to prevent community spread experienced during the COVID-19 pandemic would be prevented in any future public health emergency. 

In addition to defining agency oversight of laboratory developed procedures, the VITAL Act would require CMS to hold a public meeting to solicit recommendations on updating the CLIA provisions.  The Department of Health and Human Services would also be required to make reports to Congress regarding:

  • Recommendations for how to update the CLIA provisions; and
  • Assessment of the availability and utilization of laboratory developed testing procedures during the COVID-19 response, including:
    • Validation criteria and process, and average length of time from validation to achieving EUA approval;
    • Number of patients and samples tested by laboratories that utilized the EUA process; and
    • Recommendations to avoid delays in testing in the event of a future infectious disease outbreak.

We will continue to monitor the progress of the VITAL Act and regulations related to in vitro diagnostics.  Please contact us if you have any questions.

Authored by Blake Wilson, Christine Zimmerman, and Randy J. Prebula

Susan Tiedy-Stevenson
Senior Director
Washington, D.C.
Janice Hogan
Randy Prebula
Washington, D.C.
Blake Wilson
Christine Zimmerman


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