FDA’s Proposed Regulatory Changes to Laboratory-Developed Tests (LDTs)

By Roz Sweeney, Ph.D., Nerac Analyst

Originally Published: November 17th, 2014

Introduction

The FDA recently issued updated draft guidance for proposed regulatory changes affecting laboratory developed tests (LDTs). Laboratory developed tests (or LDTs) are traditionally IVDs developed and used by CLIA labs for treating or testing patients within that lab’s associated healthcare facility. They have historically fallen under FDA enforcement discretion, under the rationale that they fall within the practice of medicine, which is not regulated by the FDA. (While the specific tests are exempt, the labs are regulated under the Clinical Laboratory Improvements Amendment of 1988.)

Over the past 30-40 years, LDT’s have evolved considerably as medicine has gotten more complex. The FDA believes that the claims of certain LDTs are not adequately supported with evidence and that certain LDTs may lack appropriate controls yielding erroneous results. The FDA is aware of harm caused by faulty LDTs. For example, the Agency is aware of harm caused by biomarker tests for early detection of ovarian cancer. In this case, patients received inappropriate treatments or even harmful treatments as a result of these tests.

Other reasons for the need for increased oversight include LDT’s being used on larger populations (e.g. outside of the local healthcare facility) and in situations where more stringently regulated devices exist (e.g. same indication and use as PMA approved devices). The proposed regulations are intended to even the playing field in safety, efficacy, and performance of LDT’s with class I, II, III IVDs.

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