Regulation of Laboratory Developed Testing Procedures (LDPs)

What is an LDP?

Laboratory developed testing procedures (LDPs, also referred to as LDTs) are testing services that hospitals, academic, and clinical laboratories develop and use in patient care. These services are not commercially manufactured and marketed, but rather are designed, developed, validated, performed, and interpreted by board-certified professionals in a single laboratory. LDPs are often created in response to unmet clinical needs and are instrumental for early and precise diagnosis or monitoring and guidance of patient treatment. LDPs are not boxed and shipped medical products that are distributed across state lines rather they are validated testing protocols that are used in conjunction with the expertise of laboratory medical professionals.

In many cases, LDPs represent the standard of care. An assessment from 2018 indicated that there are over 70,000 genetic tests available to patients, and nearly all of them are LDPs. Patients rely on LDPs to diagnose their condition, establish risk of developing a disease, inform an appropriate treatment plan, predict response to a specific drug, or to provide a prognosis of likely disease progression. LDPs are important tools that support medical decision making and are central to public health. Additionally, because LDPs can be developed quickly and modified to fit the unique needs of patients, they are the transformative tools that shape medical practice in the future. During the COVID-19 pandemic, LDPs have been used to fill a serious gap in our testing capacity.

Are LDPs currently regulated?

Yes! Clinical laboratories and the LDPs developed and performed by their personnel are regulated by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), in addition to state level requirements, and professional accreditation bodies.

Is it time for CLIA to be modernized?

Yes! The CLIA regulations, as they currently stand, do not reflect or accommodate the advancements in molecular testing. Modernization of CLIA requirements could better achieve a flexible system that fosters innovation and promotes emerging medical knowledge to enable healthcare professionals the ability to offer precise, accurate, and the most up-to-date tests to patients. In 2018, numerous stakeholders came together calling for CLIA to be modernized. You can read more about how AMP believes that CLIA should be modernized below:

AMP 2015 CLIA
Modernization
Proposal

AMP Principles
for
LDP Oversight

AMP Position Statement:
Revisiting Oversight and Regulation of
Molecular-Based Laboratory-Developed Tests

Sign-on Letter Requesting the CLIAC
Discuss the Modernization of the
CLIA Regulations for LDPs

Sign-on Letter Expressing Concern
About Advancing the VALID Act of 2022
as Part of the FDASLA Act

If you are unable to view the embedded PDF, you can directly access the report here: https://www.amp.org/AMP/assets/File/advocacy/AMPCLIAproposalpresentation-FINAL.pdf

Why is the Verified Innovative Testing in American Laboratories (VITAL) Act necessary?

The declaration of the public health emergency, effective January 27, 2020, resulted in all tests for SARS-CoV-2 being required to have an emergency use authorization (EUA) from FDA, regardless of whether they are boxed and shipped testing kits or medical procedures. This new and duplicative regulatory hurdle delayed the widespread availability of COVID-19 diagnostic testing for weeks. As a result of a survey of laboratory professionals, the Association for Molecular Pathology found that approximately 35% of respondents noted that it took more than a month for their laboratory to receive an EUA. The practice of medicine should not be regulated by the FDA, and the Agency’s experience during this public health emergency revealed that it does not have the ability to oversee the thousands of LDPs that are vital to clinical care.

What does VITAL do?

Codifies that regulation of laboratory developed testing procedures rests within CLIA and not the FDA, including during a public health emergency,
Defines LDPs as a professional medical service,
Mandates CMS to hold a public meeting no later than 90 days after the enactment of this Act to solicit recommendations on ways to update CLIA regulations, and
Directs the HHS Secretary to report to Senate HELP Committee and House Energy and Commerce Committee on recommendations for updating CLIA as well as provide an assessment of the availability and utilization of LDPs during COVID-19 pandemic response.

Press Release

Legislative Text

Sign-On Letter

AACC, ACMG, AMP, and APC Webinar: Regulation of Laboratory Developed Tests

In October, 2021, the American Association for Clinical Chemistry (AACC), the American College of Medical Genetics and Genomics (ACMG), AMP, and the Association of Pathology Chairs (APC) released a joint webinar to discuss LDPs, current conversations in Washington around LDP oversight, and how members can advocate to ensure continued access to these critical patient services. You can view the modules from that webinar below:

If you are unable to view the embedded video above, you can directly access the video on YouTube here: https://www.youtube.com/watch?v=O6TiU5YytTE.

If you are unable to view the embedded video above, you can directly access the video on YouTube here: https://www.youtube.com/watch?v=2I_oz_ffdpo.

If you are unable to view the embedded videos above, you can directly access the videos on YouTube here: https://www.youtube.com/watch?v=iSwYAc9NQxQ.

AMP Statements Regarding LDP regulation:

Date	Subject
July 6, 2022	UPDATED: Sign-on Letter Expressing Concern About Advancing the VALID Act of 2022 as Part of the FDASLA Act
May 22, 2022	AMP Comments on the Discussion Draft of the FDASLA Act and in Particular, Subtitle C of Title VIII Which Includes VALID Act of 2022
May 6, 2022	UPDATED: Stakeholder Sign-on Letter Requesting Congress Consider the VALID Act Separately from the Medical Device User Fee Agreement (MDUFA) V Legislative Process
February 23, 2022	Stakeholder Sign-on Letter Requesting Congress Consider the VALID Act Separately from the Medical Device User Fee Agreement (MDUFA) V Legislative Process
November 2, 2021	Sign-on Letter Requesting the Clinical Laboratory Improvement Advisory Committee (CLIAC) Discuss the Modernization of the CLIA Regulations for Laboratory Developed Tests (LDTs/LDPs)
September 8, 2021	Sign-On Letter in Support of the VITAL Act
May 10, 2021	AMP Restates Support for HHS’ Statement on the Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests
October 19, 2020	AMP Comments on the Verifying Accurate, Leading-edge IVCT Development (VALID) Act
September 23, 2020	Joint Statement of Support HHS’ Statement on the Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests
May 4, 2020	AMP Response to the FDA Citizen Petition on Behalf of the Coalition to Preserve Access to Pharmacogenomics (PGx)
February 13, 2019	AMP Comments on the draft discussion of the Verifying Accurate Leading-edge IVCT Development Act of 2018
August 24, 2018	AMP Comments on FDA's Technical Assessment of the Diagnostic Accuracy and Innovation Act Draft Legislation
June 21, 2018	Stakeholder Sign-on Letter Calling for CLIA Modernization
Summer 2017	AMP SUPPLEMENTAL Comments to Reps. Bucshon and DeGette on Diagnostic Accuracy and Innovation Act Draft Legislation
April 7, 2017	AMP Comments to Reps. Bucshon and DeGette on Diagnostic Accuracy and Innovation Act Draft Legislation
October 6, 2016	AMP Comments to FDA on Use of Standards in FDA Regulatory Oversight of NGS Based IVDs Used for Diagnosing Germline Diseases
October 6, 2016	AMP Comments to FDA on Use of Public Human Genetic Variant Databases to Support Clinical Validty for NGS Based IVDs
December 13, 2015	AMP's Analysis of FDA's Report Titled "The Public Health Evidence for FDA Oversight of LDTs: 20 Case Studies"
November 18, 2015	AMP's Written Testimony to Hearing on "Examining the Regulation of Diagnostic Tests and Laboratory Operations"
June 22, 2015	AMP Comments to House E&C Committee on Regulation of In Vitro Clinical Tests Draft Legislation
February 2, 2015	AMP Comments on FDA “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)
November 18, 2014	Stakeholder Sign-on Letter on FDA draft guidance “Framework for Regulatory Oversight of Laboratory Developed Tests”