How the FDA will make diagnostic tests safer.

High quality patient care relies heavily on accurate disease diagnosis. That’s why, on April 30, 2024, the U.S. Food and Drug Administration (FDA) issued new rules designed to improve the accuracy and reliability of laboratory tests known as in vitro diagnostic products (IVDs). IVDs are tests that use samples of human tissue or blood to identify health conditions or diseases.

IVDs are a technical name for common tests that regular people use, like pregnancy or COVID-19 tests and blood glucose monitors. But doctors also use IVDs to diagnose or predict a patient’s risk of developing a medical condition or disease (such as cancer or heart disease). Then the specialist can develop treatment plans based on the results (such as choosing the correct treatment protocol). 

What most people don’t know is that many diagnostic tests escape scrutiny by the FDA. Our federal regulator, up until it issued this rule, had decided not to oversee a subset of these IVDs, known as lab-developed tests. Currently, manufacturers of laboratory-developed tests are only required to prove analytic validity (showing the test measures what the manufacturer claims it measures) in a review by the Centers for Medicare and Medicaid Services. That’s very different from assuring that a diagnostic test is backed up with clinical data to support a test’s intended use. 

The FDA now says that lack of scrutiny could result in “missed diagnoses or misdiagnoses, improper patient management decisions, or missed opportunities for beneficial treatment.”

We agree. 

Not only are patients at risk of the wrong treatment or no treatment at all, but these inaccurate tests are wasting money. One study compared accuracy of a non-regulated test to an FDA-approved test used to identify a marker for metastatic non-small cell lung cancer. The analysis showed an additional $7.3 million in treatment costs could be avoided if the more accurate FDA-approved test had been used for the cohort of 60,500 patients. 

We have been pushing Congress to force the FDA to conduct stronger oversight of these tests. And in December, U.S. PIRG filed comments to support the FDA’s decision to start regulating these lab-developed tests. We are cheering that the FDA has taken on this job, without waiting for Congress to tell it to.  

“The FDA is putting patients first by beginning to make many lab test developers prove their tests are accurate and clinically reliable before they are offered for use on patients,” said Patricia Kelmar, U.S. PIRG’s health care campaigns senior director in a press release after the rule was announced. “Physicians and their patients rely on the outcomes of lab-developed tests to make life and death decisions about treatment. For too long, makers of these tests have remained under-regulated by the FDA.”