RELEASE: New FDA policy will protect patients from inaccurate lab tests

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Agency issues rules, supported by U.S. PIRG, for greater oversight of diagnostic testing

WASHINGTON — The U.S. Food and Drug Administration (FDA) on Monday issued new final rules designed to improve the accuracy and reliability of laboratory tests known as in vitro diagnostic products (IVDs). Last December, U.S. PIRG filed comments in support of the FDA’s proposed IVDs rules. The nonprofit consumer advocacy group has been pushing for stronger oversight of these tests, which are generally used by medical professionals on samples of human tissue or blood (although consumers can buy some IVDs, such as pregnancy tests and blood glucose monitors, directly off store shelves). Until now, no one has strictly regulated these products.  

“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. “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.” 

IVD tests can diagnose or predict the patient’s risk of developing a medical condition or disease (such as cancer or heart disease) and then providers develop treatment plans based on the results (such as choosing the correct treatment protocol). 

Currently, manufacturers of laboratory-developed IVDs (LDTs) 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 says that lack of scrutiny could result in “missed diagnoses or misdiagnoses, improper patient management decisions, or missed opportunities for beneficial treatment.” 

The FDA justified the new rule as “a significant step forward for public health”, answering its own concern that “IVDs offered as LDTs do not have appropriate assurances of safety and effectiveness.” Increased oversight set forth in this rule requires the laboratories developing most of these tests to prove clinical validity, demonstrating that the results show the presence or absence of the condition or disease.

U.S. PIRG is still analyzing the 528-page rule and has some reservations, notably the 3 ½-year delay before the new oversight takes place. The consumer group is worried about the scope of the exceptions put forth in the rule. Some tests already on the market and tests for “unmet needs” (e.g. those where there is no other existing test available for that diagnosis) are exempted from this higher level of scrutiny. However, this is a good step toward improved oversight and regulation of lab-developed tests.

“This rule should eventually mean better patient safety. However, we’ll need to monitor its implementation to make sure that more lab-developed tests undergo close FDA oversight and fewer are exempted,” said Kelmar.