RELEASE: Consumer group urges FDA to protect patients from inaccurate lab tests

Many patients are at risk of misdiagnosis

WASHINGTON — U.S. PIRG filed comments Monday with the U.S. Food and Drug Administration (FDA) to support proposed rules that would improve the accuracy and reliability of laboratory tests used to diagnose and treat patients across the United States.  

The nonprofit consumer advocacy group has been pushing for stronger oversight of laboratory-developed in vitro diagnostic products (IVDs). These tests, conducted on samples of human tissue or blood, are used to diagnose or predict the risk of developing a medical condition or disease (such as cancer or heart disease) and to develop treatment plans based on the results (such as choosing the correct treatment protocol). Some IVDs such as pregnancy tests and blood glucose monitors are also sold directly to consumers. 

Currently, manufacturers of laboratory-developed IVDs 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. However, manufacturers don’t have to complete that review until up to two years after they offer the LDT to the public. Under the proposed FDA rule, these tests would have to undergo the same review required of other medical devices. That review would, among other standards, require the laboratories developing these tests to prove clinical validity, demonstrating that the results show the presence or absence of the condition or disease. 

“The FDA is putting patients first with these rules that will make developers prove their tests are accurate and reliable,” said Patricia Kelmar, U.S. PIRG’s health care campaigns senior director. “Physicians and their patients rely on the outcomes of lab-developed tests to make life and death decisions about treatment. For too long, the makers of these tests have not had to prove their accuracy and reliability, with little to no scrutiny from the FDA.” 

An excerpt from U.S. PIRG’s comments:

Over time, LDTs have gotten more complex and are being used in larger patient populations than before. And LDTs are used to develop treatment plans for complex conditions. LDTs are no longer being used only on small patient populations in one site of service. Today, laboratories are taking in large numbers of testing samples from around the country so the impact of even one inaccurate test can be affecting thousands of lives. It is crucial to have accurate and reliable tests. For these reasons and more, there is much more at stake when LDTs are allowed on the market without needing to prove clinical validity, demonstrating that the results show the presence or absence of the condition or disease. This proposed rule will set the FDA on the path to enforcing important standards of validity that are imposed on other medical devices. 

The FDA issued this proposed rulemaking after a bipartisan group of U.S. Senators and Representatives introduced the related VALID Act in 2022. That legislation never received a full vote in Congress after hospitals and academic medical centers which manufacture these tests opposed it.