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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  • 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 »...
  • Letter to FDA Regarding Oversight of Laboratory Developed Tests

    September 15, 2010
      September 15, 2010 Jeffery E. Shuren, M.D., J.D. Director, Center for Devices and Radiological Health U.S. Food and Drug Administration Building WO66, Room 5442 10903 New Hampshire Ave. Silver Spring MD 20993 RE: Docket No. FDA-2010-N-0274 – Oversight of Laboratory Developed Tests Dear Dr. Shuren: The undersigned groups, which represent the full spectrum of laboratory medicine operations and the providers of clinical andContinue Reading »...
  • Comments on Supplemental LDTs

    September 15, 2010
      September 15, 2010 RE:       Docket No. FDA-2010-N-0274   —  Oversight of Laboratory Developed Tests; Public  Meeting;  Request  for  Comments   EXECUTIVE  SUMMARY Clinical laboratories are providers of testing services; not medical device manufacturers, a fact that necessitates flexibility and innovative thinking on FDA’s part in regulating LDTs. (See page  3 -4) Regulation of clinical laboratory developed tests (LDTs) should not vary based on the settingContinue Reading »...
  • Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests

    July 16, 2010
    July 16, 2010 For Immediate Release Contacts: Alan Mertz, 202-637-9466; amertz@clinical-labs.org David Mongillo, 202-637-9466; dmongillo@clinical-labs.org Clinical Laboratory Industry on Role for FDA in Regulating Laboratory Developed Tests “21st Century tests require 21st Century Solutions” Washington, DC — The Food and Drug Administration can promote progress toward personalized medicine by approaching the oversight of laboratory developed tests (LDTs) in a focused, flexible, and balanced wayContinue Reading »...
  • Comments on Device Tax and LDTs

    February 28, 2010
    See Original PDF here. February 28, 2010 Internal Revenue Service 1111 Constitution Avenue, NW Washington, DC 20224 Re: Notice 2010-89 Dear Ladies and Gentlemen: The American Clinical Laboratory Association (ACLA), is pleased to provide these comments regarding implementation of the excise tax on medical devices in new Section 4191 of the Internal Revenue Code (the ―Code‖), as added by Section 1405 of the HealthContinue Reading »...
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