Laboratory Developed Tests

Laboratory Developed Tests (LDTs) are tests that hospitals, academic, and clinical laboratories develop as testing services according to their own procedures. These tests are often created in response to unmet clinical needs, and are commonly used for early and precise diagnosis, monitoring, and guiding patient treatment. LDTs are also used to diagnose and assess diseases…

Laboratory Developed Tests (LDTs) are tests that hospitals, academic, and clinical laboratories develop as testing services according to their own procedures. These tests are often created in response to unmet clinical needs, and are commonly used for early and precise diagnosis, monitoring, and guiding patient treatment. LDTs are also used to diagnose and assess diseases and disorders for rare and emergent diseases, or those with small patient populations. Nearly all diagnostic tests and FDA-approved test kits begin as LDTs, and in many cases, LDTs represent the standard of care.

The ability of laboratories to develop custom diagnostic tests has been critical to the growth of personalized medicine and keeping pace with the changing face of disease to best serve patients and clinicians. Molecular and genetic diagnostics have advanced our medical knowledge through ever-increasing levels of accuracy and precision in both screening and diagnostic tests, and they better guide diagnosis, and prevention or treatment decisions. Through these innovations, clinical laboratories have played a critical role in reducing medical costs and improving the quality of patient care.

The current oversight framework has worked well to promote innovation and advance patient care. To continue these advancements into the twenty-first century, ACLA believes the appropriate time has arrived to design a new, logical framework that contemplates the future of clinical laboratory diagnostics. We support the pursuit of comprehensive statutory reform for the oversight of both LDTs and In Vitro Diagnostics (IVDs) through a transparent process with Congress, the Administration, and other stakeholders.

In pursuing reform, ACLA strongly asserts that any new framework must ensure continued innovation and robust patient access to accurate and reliable clinical laboratory diagnostic services. Core principles that will accomplish these paired goals include: 1) reform that recognizes diagnostics as distinct and not inappropriately incorporated into regulatory frameworks designed for other products or services; 2) “grandfathering” and transition policies that will not disrupt patient access to currently-available clinical laboratory services; and 3) an appropriate balance between both innovation, and assurances for accuracy and reliability through smart regulation.

Our Key Principles for Diagnostic Reform can be found here.

 

 

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  • ACLA Expresses Concern with FDA Guidance on Laboratory Developed Tests (LDTs)

    July 31, 2014
    WASHINGTON, DC – In response to today’s announcement that the Food and Drug Administration (FDA) will release a draft guidance in 60 days to regulate laboratory developed tests (LDTs), the American Clinical Laboratory Association (ACLA) urged the agency to exercise caution, and expressed concern that another layer of regulation could stifle diagnostic innovation and ultimately jeopardize patient access to timely and effective treatments. Historically,Continue Reading »...
  • ACLA Praises Letter to OMB From Nation’s Leading Academic Medical Center Labs Opposing FDA Regulation of Laboratory Developed Tests

    July 17, 2014
    WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) today lauded a letter sent from twenty three laboratory directors of the nation’s most prestigious academic medical centers to Brian Deese, Acting Director of the Office of Management and Budget (OMB), urging him to refrain from releasing draft guidance from the Food and Drug and Administration (FDA) that would impose an additional cumbersome regulatory approvalContinue Reading »...
  • ACLA Response to LDT Demo Notice

    July 02, 2014
    July 1, 2014 Major General Richard W. Thomas, MD Chief Medical Officer and Director Defense Health Agency, Healthcare Operations Directorate 7700 Arlington Boulevard Falls Church, VA 22042 Dear General Thomas: On behalf of the American Clinical Laboratory Association (“ACLA”) and our members, I am writing to express our appreciation for the recent action by the Defense Health Agency (“DHA”) to establish a demonstration projectContinue Reading »...
  • Clinical Labs Industry Files Petition Against Potential FDA Regulation of Laboratory Developed Tests

    June 04, 2013
    Washington, D.C. — The American Clinical Laboratory Association (ACLA) filed today a citizen petition under the Federal Food, Drug, and Cosmetic Act (FDCA) challenging Food and Drug Administration (FDA) authority to regulate laboratory developed tests (LDTs) in response to statements that the agency intends to regulate LDTs as “devices” under the FDCA. As detailed in ACLA’s petition, LDTs are in vitro assays that clinicalContinue Reading »...
  • Citizen Petition to FDA Regarding Laboratory Developed Tests (LDTs)

    June 04, 2013
      Division of Dockets Management Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061 Rockville, MD 20852 CITIZEN PETITION The American Clinical Laboratory Association (ACLA) submits this petition under the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) to request the Commissioner of Food and Drugs to take the actions described in Section A with respectContinue Reading »...
  • Letter to Daniel Levinson Regarding LDTs in Work Plan

    November 15, 2012
      November 15, 2012   Mr. Daniel Levinson Office of the Inspector General Department of Health and Human Services 300 Independence Avenue SW Washington, DC 20201   Dear Mr. Levinson:   We are writing with regard to an item in the Office of the Inspector General’s (“OIG’s”) Work Plan for 2013 on oversight of Laboratory-Developed Tests (“LDTs”). The American Clinical Laboratory Association (“ACLA”) isContinue Reading »...
  • Comments on Proposed UDI Rule

    November 07, 2012
        November 7, 2012 BY ELECTRONIC SUBMISSION Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2011-N-0090; RIN 0910-AG31; Unique Device Identification System: Proposed Rule Dear Sir/Madam: The American Clinical Laboratory Association (“ACLA”) is pleased to provide comments to the Food and Drug Administration (“FDA”) on issues related to the proposed rule,Continue Reading »...
  • Letter to Chairman Pitts and Ranking Member Pallone Regarding MDUFA

    May 07, 2012
      May 7, 2012   The Honorable Joe Pitts Chairman Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives 2125, Rayburn House Office Building Washington, DC 20515 The Honorable Frank Pallone, Jr. Ranking Member Subcommittee on Health Committee on Energy and Commerce U.S. House of Representatives 2322-A, Rayburn House Office Building Washington, DC 20515   Dear Chairman Pitts and Ranking MemberContinue Reading »...
  • ACLA Expresses Strong Support for Bill Modernizing Regulation of Lab-Developed Tests

    October 14, 2011
    For Immediate Release, October 14, 2011 Contact: Alan Mertz, 202-637-9466 ACLA Expresses Strong Support for Bill Modernizing Regulation of Lab-Developed Tests Washington DC – The American Clinical Laboratory Association (ACLA) today announced its “full and strong” support for legislation introduced by Rep. Michael Burgess (R-TX) that would modernize the current regulatory pathway for all laboratory developed tests. The legislation, H.R. 3207, the Modernizing LaboratoryContinue Reading »...
  • Comments on RUO IUO

    August 24, 2011
      August 24, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville MD 20852 RE: Docket No, FDA-2011-D-0305 Draft Guidance for Industry and FDA Staff: Commercially Distributed In Vitro Diagnostic Products labeled for Research Use Only or Investigational Use Only: Frequently Asked Ouestions Dear Sir or Madam: The American Clinical Laboratory Association (“ACLA”) is pleased to provide commentsContinue Reading »...
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