Having blood work done at a doctor's office is nothing new for most people, but most of these tests currently do not have FDA approval. However, now the FDA wants a larger role.
Blood work is done by companies such as Myriad Genetics Inc., Quest Diagnostics Inc. and Laboratory Corporation of America Holdings. It is used to test for a variety of diseases such as diabetes and high cholesterol. It may also be used to help find the best drug to use for certain cancer patients. As these tests get more sophisticated and carry greater consequences, the FDA wants to play a larger role in the regulation of these tests.
"Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA," said Dr. Margaret A. Hamburg, FDA Commissioner. "Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today's action demonstrates the agency's commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient."
Previously, the FDA did not regulate these laboratory developed tests (LDTs) because they were generally used for rare or low-risk diseases. However, as technology grows more sophisticated, so do these tests.
The FDA is only asking for high risk LDTs to undergo testing for safety and efficacy before being used by consumers. The exceptions to this are tests that currently have no other FDA-approved test available. Procedures and protocols for new tests will be phased in over the next several years.
"The agency's oversight would be based on a test's level of risk to patients, not on whether it is made by a conventional manufacturer or in a single laboratory, while still providing flexibility to encourage innovation that addresses unmet medical needs," said Dr. Jeffrey Shuren, director of the FDA's center for Devices and Radiological Health.
Not everyone is happy with the FDA's decision to have a heavier hand in the situation. American Clinical Laboratory Association president Alan Mertz said LDTs already have oversight in the form of federal laws in place.
"FDA intervention would add another layer of unnecessary and duplicative regulation to the LDT approval process, impose a stranglehold on diagnostic innovation and reduce patient access to the latest groundbreaking diagnostic advancements," he said in a statement.
