Today, many LDTs are made from complex components, marketed across the country, often by large companies, and performed by laboratories without direct connection to the patient’s care team. These tests also promise to diagnose a wide range of serious conditions, from genetic disorders to cancer. They are widely used by hospitals and clinics, even for patients in remote locations.

These changes in how LDTs are made and used put patients at a much higher risk of being harmed by inaccurate or unreliable tests. Case studies of LDTs marketed without FDA oversight that have produced inaccurate or misleading results and harmed patients support that concern. 

In response, the FDA has decided that LDTs should be subject to the same standards as other medical devices. 

Special interests representing the clinical laboratory industry are challenging the FDA’s ability to regulate LDTs, claiming that LDTs should remain under the exclusive oversight of the Centers for Medicare & Medicaid Services (CMS), which provides oversight of some aspects of clinical laboratories through the Clinical Laboratory Improvement Amendments (CLIA). CLIA enforces certain standards to ensure laboratories meet basic quality and proficiency standards but does not empower CMS to keep inadequate tests from reaching patients or to ensure that tests can produce the medically relevant results they claim.

On behalf of Dr. Reshma Ramachandran, Dr. Joseph S. Ross, and Kushal T. Kadakia – practicing physicians and healthcare policy experts, Democracy Forward filed an amicus brief defending the FDA’s authority to regulate LDTs.

Our brief documents the FDA’s authority to protect the public from inaccurate and unreliable diagnostic tests and explains why – in light of seismic changes in the way that LDTs are made, marketed, and used, which has significantly increased the risk they pose to patients if left unregulated – FDA oversight is urgently needed to close dangerous gaps and ensure that LDTs are safe and effective for use in healthcare decision making. 

The brief also shows instances where LDTs have produced inaccurate or unreliable results to illustrate patient harm from wrong tests. For example, a patient could receive a false-positive result for a serious condition, like cancer, which might cause the patient to experience anxiety and undertake invasive and risky treatments unnecessarily. Or, a false-negative result could cause a patient to delay or forego a needed treatment, which might adversely affect their health and recovery. The FDA’s role is essential to ensure that LDTs meet consistent safety and accuracy standards to protect patients.

Without FDA review, patients and doctors may not have access to clear, accurate information about a test’s performance and limitations. By requiring tests to go through FDA evaluation, patients can be better informed about the reliability of the tests they count on.