Regulatory reform of Laboratory Developed Tests (LDT) has been a long time in the making, but lawmakers and industry groups alike are debating to what degree of oversight is appropriate. Legislation called the VALID (Verifying Accurate Leading-edge IVCT Development) Act has been in the works since 2018 and was introduced to the House in 2021. This bill's purpose is to grant the FDA the authority to regulate LDTs. In December 2022, the VALID Act was tacked on to a year-end omnibus spending package, but provisions to improve diagnostics regulation were ultimately excluded.
The VALID Act sought to increase regulatory oversight by means of reclassifying LDTs as In-Vitro Clinical Tests (IVCT), placing them within the same regulatory scheme as In-Vitro Diagnostics (IVD) under the FDA’s authority. The proposed legislation is intended to create a risk-based framework to oversee the development and implementation of advanced and reliable clinical diagnostic tests. Under this system, IVCTs would require FDA premarket approval before introduction into interstate commerce, with the exception of certain exemptions surrounding legacy tests and risk levels.
Regulatory Framework for LDTs
Unlike the IVD test kits produced by authorized manufacturers, LDTs traditionally are clinical tests developed and performed by single laboratories. However, it is increasingly common that these labs are testing patient samples shipped from far and wide, enabling a much further reach than ever before.
For decades, clinical laboratories have submitted to oversight by the Centers for Medicare & Medicaid Services (CMS) under CLIA (Clinical Laboratory Improvement Amendments). CLIA review typically occurs only once a lab has begun testing and only focuses on some components of analytical validity. The FDA review of IVCTs would take place pre-market and include a broader scope of investigation on clinical validity and intended use.
Supporters of the VALID Act argue that under current federal lab standards, the accuracy of LDTs is not adequately overseen, potentially putting patient care in harm’s way. Clinical decision-making relies on the accuracy and validity of clinical tests. A stronger regulatory framework is especially paramount as clinical tests are increasingly being broadly marketed. Advocates maintain that tighter control of test performance would help ensure that all tests are safe, effective, and work as intended. Without reform, clinical decision-making will continue to be undermined by under-regulated LDTs.
Opponents of this legislation are concerned that patient access to advanced clinical diagnostics will be negatively impacted. For decades clinical testing laboratories have enjoyed the ability and freedom to innovate under CLIA. Submitting to FDA oversight under the VALID Act would hinder the availability of cutting-edge clinical tests by weighing down developers with regulation, stifling innovation, and increasing costs, all of which are barriers to market.
It is expected that FDA will prioritize LDT regulatory reform in 2023. The FDA continues to engage closely with Congress and the diagnostics industry, hoping that legislation will pass to enable the VALID Act to prevail. While it’s preferred that diagnostic policy updates be directed by legislative pathways, it is within the agency’s administrative rule-making power to enact guidelines to revamp the regulation of lab-based testing. Whether reform will be prescribed by Congress or influenced by the FDA is still to be seen.
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Calia Harakaly – Associate Medical Device Consultant