The FDA has proposed a new regulatory plan to oversee potentially thousands of laboratory-developed medical tests that the agency contends may be prone to errors. In an announcement made on July 2014, the U.S. Food and Drug Administration has made it clear that for the first time it will regulate many diagnostic tests, especially for cancer and other chronic illnesses. The tests would include those that are used by healthcare professionals to guide medical treatment for their patients, and some genetic tests. Already, the FDA oversees direct-to-consumer tests irrespective of whether they are traditional diagnostics or LDTs.
The agency estimates that there are currently around 11,000 LDTs developed by about 2,000 labs in the U.S. The regulations will be more consistent with FDA’s current regulation of in vitro diagnostic devices. In vitro diagnostic test involves taking a sample from the patient, such as blood, saliva, or a tissue biopsy, to diagnose a medical condition.
Independent laboratories often provide a huge variety of diagnostic tests to hospitals and other healthcare providers. Though the Centers for Medicare and Medicaid Services has a certain amount of jurisdiction in the area, these tests are not FDA regulated.
According to the FDA Commissioner Margaret A. Hamburg, “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Such tests have also led to incorrect diagnoses of autism. The agency will begin by scrutinizing ‘high-risk’ tests. There will be a lengthy time period first, including a 60-day notice to Congress and a comment period before the plan can become final”.
All the proposed plans are outlined in FDA’s detailed “Framework for Oversight of Laboratory Developed Tests”. The agency has also announced that no changes will be made for LDTs used for organ, stem cell, or tissue transplants, as they require a very careful and complex matching of donor to recipient, and rely heavily on sequencing the complicated HLA system of the human genome.