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 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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