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.
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.
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:
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
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.
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.
|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”|