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Laboratory Developed Test (LDT)
A laboratory developed test (LDT) is a type of in vitro diagnostic (IVD) procedure that an individual lab develops for its own use only.
In academic medical center laboratories, these proprietary clinical laboratory tests often are created to address an unmet clinical need.
Currently, LDTs are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They are generally not reviewed by the Food and Drug Administration (FDA), although proposed legislation before Congress seeks to change that arrangement.
LDTs can only be offered and used by a single clinical laboratory; otherwise, they require FDA authorization before they can be manufactured or used outside of the lab they were developed in.
LDTs have played an important role in promoting the rapid development of new testing technologies. There has, however, been concern expressed by the FDA that the lack of oversight for these tests causes patients to get unnecessary treatments.
These tests played an important role in the early response to the SARS-CoV-2 pandemic. Many COVID-19 tests started as LDTs that then obtained Emergency Use Authorization (EUA) from the FDA.
The FDA has argued that due to advances in technology and business models, LDTs have evolved and proliferated significantly since the FDA first obtained authority to regulate all in vitro diagnostics in 1976. Some LDTs are now more complex, have a nationwide reach, and present higher risks, such as detection of risk for breast cancer and Alzheimer’s disease. In such cases, LDTs are similar to other IVDs that have undergone pre-market review.
In 2010, the FDA announced its intention to reconsider its policy of enforcement for LDTs. Four years later, the agency notified Congress of its intent to issue a draft oversight framework for LDTs based on risk to patients rather than whether they were made by a conventional manufacturer or a single laboratory. This draft oversight framework included pre-market review for higher-risk LDTs, like those used to guide treatment decisions, including the many companion diagnostics that have entered the market as LDTs. In addition, under the draft framework, the FDA would continue to exercise enforcement discretion for low-risk LDTs and LDTs for rare diseases, among others.
Those statements set the stage for more recent developments in how LDTs are regulated. In 2021, the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) was proposed by a bipartisan group of lawmakers. If the VALID Act becomes law, the FDA will have clear authority to regulate LDTs and generally will require these tests to have FDA approval before being marketed or used. CLIA’s influence over LDTs would wane under the VALID Act.
A substantial portion of laboratory leaders and pathologists believe that passing the VALID Act will stifle innovation in the field of clinical lab testing due to the costs and resources associated with FDA review. Proponents of the VALID Act argue that FDA pre-market approval is needed for all IVD tests because they are similar to medical devices and thus require extensive data collection.
As of August 2022, the VALID Act had been appended to a larger Senate bill that focused on FDA user fees. A vote is still pending on the larger bill. The House version of the VALID Act remained an individual bill.
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The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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